In-Country Representatives and Registration Holders: 2026 Guide

TL;DR

Who holds your registration is a switching-cost decision, and the switching cost is set by each market's transfer rules, not by the size or goodwill of the distributor. In the comparable name-based national-register subset, between 59.3% (Singapore) and 90.0% (Indonesia) of imported-device registrations are held by an entity other than the manufacturer or an identifiable affiliate. The UAE directory produces a 99.98% non-matching supplier-name share; its supplier field is a separate proxy, not a verified registration-holder field ^{1234567891011121314}.

Dependence on one holder is the norm. Between 72.1% (Brazil) and 89.8% (Hong Kong) of foreign manufacturers have their entire registered portfolio in a market with a single local holder, and 60.7% (UAE) to 91.3% (Israel) of registrations sit with holders that represent five or more manufacturers. Serving many named manufacturers can indicate an intermediary, although subsidiaries and company-name fragmentation also contribute ^{1234567891011121314}.

The transfer rules fall into three regimes. Where the manufacturer owns the file (United States, Canada, European Union), changing the local representative is a re-appointment. Where a transfer procedure exists, it needs the incumbent's signature: Singapore charges S$880 and quotes 40 working days, Malaysia RM 500 per registration and about 30 working days, Australia no fee and about 10 working days but only with the current sponsor's consent ^15161718. In appointment-dependent markets, budget for a new filing where the applicable route requires it. The reviewed issuance pages for the UAE and Israel establish local-holder requirements but do not, by themselves, prove that every holder change requires a new registration.

An independent holder prices that risk. Pure Global's flat annual in-country representation fee is USD 1,000 for a US Agent and USD 2,000 to 3,000 per registration in the other markets on its list, with submission on a reference approval, renewals, modifications and authority correspondence included Pricing. Compare that recurring cost and its exit terms with the expected cost of transfer, duplicate filing and any supply interruption. An independent holder separates the sales relationship from the file, but still needs a cooperation and handover contract.

Three ways to hold a licence, and why the default gets chosen for you

A manufacturer entering a market that requires a local registrant has three structures to choose from: its own local entity, the importing distributor, or an independent in-country representative. Each optimises a different variable, and the choice is often made by default in the first distribution agreement rather than by design.

An own entity optimises control. A locally incorporated subsidiary can hold marketing authorisations in its own name, appoint or replace distributors freely, and keep the technical documentation in the group. The cost is a legal entity, local licences, local staff and, in several markets, a local quality-system certificate. For a company testing a secondary market, compare those fixed costs with realistic first-year volumes and the value of retaining control.

A distributor holder optimises speed and cash. The distributor already has the local establishment licence, files the registration as part of the distribution deal, clears customs and talks to the authority. The manufacturer avoids an upfront regulatory project. Where the agreement and local rules assign all three roles, the distributor becomes the registrant, importer and authority counterpart, and in many markets the registration certificate is issued to the distributor rather than to the manufacturer.

An independent representative separates the regulatory role from the commercial one. A third party outside the sales channel holds the registration or acts as the statutory representative, keeps custody of the file and the authority correspondence, and issues authorisations to one or several distributors. The manufacturer pays a recurring fee and keeps the freedom to change its commercial partners.

Distributor holding became the default for practical reasons. Authorities wanted a domestic party to accept notices and liability, and overseas manufacturers relied on local trading houses for language, customs and relationships. Writing in Medical Device and Diagnostic Industry in July 2000, Patricia M. Flood described the consequence: "Products are registered in the distributor's name, which presents a problem should a company wish to switch distributors; typically, in such cases the products must be reregistered" ¹⁹. The register data below show that the pattern she described still dominates.

The World Health Organization's Global Model Regulatory Framework (2017) keeps the roles separate on paper: the manufacturer, the authorised representative acting under a mandate, the importer and the distributor each have their own obligations, and the framework notes that the authorised representative may also be the importer or distributor ²⁰. That overlap is where the default comes from. A distributor that steps into the representative role holds both the commercial channel and the regulatory file, and the two are then hard to separate ²¹.

Who holds the licence today

We measured who holds imported-device registrations in thirteen national registers, using public snapshots taken between 2 and 12 September 2026. The name-comparison subset indicates substantial use of non-matching local entities. It includes records with different legal meanings, which are kept separate in the interpretation.

The chart shows the share of foreign-manufacturer registrations whose holder is neither the manufacturer nor an identifiable affiliate. All figures are name-based estimates: names were normalised by removing punctuation and legal suffixes, and holder and manufacturer were treated as one family when the names were equal, one contained the other, or they shared the first distinctive word.

Outside Canada, where the manufacturer holds the licence by regulation, third-party holding runs from 59.3% in Singapore to 90.0% in Indonesia ^{1234567891011121314}. In the UAE product directory, the supplier-name proxy stands at 99.98% of 4,553 foreign records; the actual holder must be confirmed from the authorization ^891011121314. Brazil is at 81.0% of 68,354 foreign registrations, Australia at 72.5% of 57,681 foreign ARTG inclusions, Colombia at 64.8% of 18,889 and Hong Kong at 60.6% of 10,313 valid listings ^{1234567891011121314}.

Taiwan and Israel are omitted from this chart because the holder and manufacturer names are in different scripts (Traditional Chinese and Hebrew against Latin), so name-based affiliation stays uncomputed. Both markets still appear in the concentration and dependence measures below.

The type mix splits the holder base into manufacturer affiliates, distributors or trading companies, independent representation firms and unclassified entities. This is a separate entity-type classification: an affiliate of one manufacturer may hold another manufacturer's products. Its affiliate share therefore differs from the pairwise name-match share above; neither metric proves corporate ownership. The thirty largest holders in each market were labelled by hand; the remainder were labelled by keyword rule; anything else is reported as unclassified rather than assumed to be a distributor.

Independent representation firms are a thin slice everywhere: 0.2% of foreign registrations in Colombia, 1.7% in Indonesia, 2.6% in Singapore and Hong Kong, 2.8% in Brazil and 4.4% in Australia ^{1234567891011121314}. Entities classified as manufacturer affiliates account for 53.1% of Singapore and 57.2% of Hong Kong records in the separate holder-type screen ^1234567. Distributors dominate Brazil (45.6%) and the UAE (74.4%) ^891011121314. In Indonesia 75.1% of foreign registrations sit with unclassified local companies ^1234567. Indonesian eligibility and appointment rules define who may register an imported device; they leave the commercial role of these unclassified companies unresolved in this dataset ²².

Concentration by holder is low. The ten largest holders account for 34.8% of foreign registrations in the UAE and 28.3% in Hong Kong, 23.4% in Australia and 22.1% in Singapore, then 19.6% in Israel, 18.8% in Colombia, 18.3% in Taiwan, 15.4% in Mexico, 14.7% in Brazil, 12.7% in Indonesia and Malaysia, 10.9% in Vietnam and 10.3% in Canada ^{1234567891011121314}.

No single holder dominates the measured record totals. Brazil has 2,693 distinct holders of foreign registrations, Australia 2,803 sponsors, Taiwan 2,465 licence holders and Vietnam 8,162 companies in its registration publications ^{1234567891011121314}. These counts indicate a fragmented landscape, not a list of providers qualified or willing to take a particular product. Transfer rules, technical competence and contractual access all constrain the shortlist.

Single-holder dependence is the number that matters

Market-level fragmentation hides manufacturer-level concentration. The figure that governs a manufacturer's risk is how many holders it uses, rather than how many the market has.

In Hong Kong 89.8% of foreign manufacturers (1,725 of 1,922) have all their listings with one Local Responsible Person ^1234567. In Singapore the share is 87.7% (3,044 of 3,472), in the UAE 82.9% (673 of 812), in Indonesia 78.6% (6,730 of 8,564), in Taiwan 77.0% (5,553 of 7,216), in Australia 75.3% (7,029 of 9,338), in Colombia 75.2% (3,975 of 5,286), in Israel 72.5% (7,102 of 9,800) and in Brazil 72.1% (6,212 of 8,611) ^{1234567891011121314}.

Spreading the file across holders is rare. The share of manufacturers with three or more holders in a market runs from 1.6% in Hong Kong and 3.1% in Singapore to 10.6% in Australia, 10.7% in Israel and 11.5% in Brazil ^{1234567891011121314}. Most manufacturers place their whole national portfolio with one counterpart.

That counterpart is usually not a captive subsidiary. Grouping registrations by how many manufacturers each holder represents, multi-principal holders (five or more manufacturers) hold 91.3% of foreign registrations in Israel (24,963 of 27,327), 83.4% in Australia (48,076 of 57,681), 82.0% in Indonesia (51,369 of 62,679), 79.4% in Taiwan, Brazil and Singapore, 75.8% in Hong Kong, 60.8% in Colombia and 60.7% in the UAE ^{1234567891011121314}.

A holder linked to dozens of manufacturer names warrants an intermediary-role check; corporate independence requires a separate ownership check. In Indonesia, PT Tawada Healthcare holds 820 imported registrations across 125 manufacturers, PT Enseval Medika Prima 670 across 101, PT Intisumber Hasil Sempurna Global 606 across 98 and PT Transmedic Indonesia 413 across 109 ^1234567. Australia has 684 sponsors that represent five or more manufacturers, Brazil 774 such holders and Taiwan 576 ^{1234567891011121314}.

The combination is the exposure: one holder per manufacturer, and that holder serving many manufacturers. A multi-principal distributor allocates its sales effort and tender bids across its portfolio, and the manufacturer's leverage in that relationship depends on whether it can take its file elsewhere. In consent-based transfer regimes, described below, taking the file elsewhere requires the holder's signature.

Canada is the counter-example that shows how regulatory design removes the problem. Under the Medical Devices Regulations, the licence for a Class II, III or IV device is applied for and held by the manufacturer, and importers and distributors operate under establishment licences instead ²³²⁴. In the active licence listing, 32,360 of 35,714 licences (90.6%) are held by companies outside Canada, and our manufacturer-holder comparison is zero by construction. This reflects the register's legal manufacturer role, which can include an own-brand manufacturer, rather than proving that the licence holder operates the factory ^891011121314. From 14 December 2026, foreign distributors selling through a licensed Canadian importer will no longer need their own establishment licence ²³²⁴. A manufacturer can change its Canadian importer without touching its licences.

Europe and the United States: separate the representative from authorization ownership

In the EU and US, ownership of a conformity certificate or premarket authorization is distinct from the local representative or US Agent appointment. The actual legal manufacturer, authorization owner and establishment registrant must still be identified; they need not all be the same corporate entity.

In the EUDAMED public device records (snapshot of 25 July 2026), 1,543,197 UDI-DI records carry a manufacturer registration number from outside the EU-27 and EEA/EFTA. Of those, 1,302,407 (84.4%) name an authorised representative. 1,012 distinct representatives serve 8,478 non-EU manufacturers; 432 manufacturers use more than one ²⁵.

The EU representative market is concentrated among professional firms. The ten representatives with the most manufacturers together appear for 4,500 manufacturers, 53.1% of non-EU manufacturers that name a representative, and the ten largest by record volume hold 58.8% of representative-named non-EU records (765,265 records) ²⁵. SUNGO Europe B.V. represents 1,443 manufacturers across 97,759 records, Shanghai International Holding Corp. GmbH (Europe) 469 across 108,954, Emergo Europe B.V. 459 across 57,053, MedPath GmbH 385 across 38,765 and Obelis s.a. 331 across 195,875 ²⁵.

Representatives cluster in a few member states: 462,306 representative-named non-EU records point to a German representative, 316,908 to the Netherlands, 211,052 to Belgium and 102,725 to Spain. The manufacturers they serve are mainly in China (560,225 records), Turkey (227,757), the United States (221,714), South Korea (86,370), Japan (79,192), the United Kingdom (72,028) and Israel (67,926) ²⁵.

The legal basis is Article 11 of Regulation (EU) 2017/745: a non-EU manufacturer designates a representative by written mandate, and the mandate leaves the manufacturer's core obligations with the manufacturer ²⁶. Article 12 governs the change: an agreement between the manufacturer, the incoming representative and, where practicable, the outgoing one sets the termination and start dates, how long the outgoing name may still appear on labelling, the transfer of documents, and the outgoing representative's duty to forward complaints ²⁶. MDCG 2022-16 expects that agreement to be tripartite unless the outgoing representative has ceased to exist or is untraceable ²⁷. Changing only the representative normally follows the mandate and Article 12 handover route, alongside relevant database, labeling and certificate updates. Document access and transition cooperation still matter.

The US works the same way. In the openFDA registration and listing data (metadata of 31 August 2026, retrieved 12 September 2026), 334,839 listing records split into 156,264 US and 178,575 foreign. 141,279 foreign records (79.1%) name a US Agent business and 37,296 (20.9%) leave the field blank. The ten largest agent names hold 25.6% of the named foreign records ²⁸.

Listing records overweight large manufacturers, so establishments are the better unit. The FDA registration export of 22 July 2026 contains 25,436 distinct establishments, 15,294 of them outside the US ²⁸. By establishments served, Registrar Corp is agent for 1,093 foreign sites (6,797 listing records) and Regrek LLC for 780 (7,423 listing records); Emergo Global Representation serves 241, IRC USA 172, MEDAGENT 163, FDAbasics 130, ROC Chinese-European Industrial Research Society 114, ABMED Medical Technology 111 and Liberty Management Group 109 ²⁸. The 25 largest independent agent names together serve 3,169 foreign establishments, 20.7% of the total ²⁸. Manufacturer groups that act as agent for their own plants serve a handful each: Zimmer Biomet 24, Arthrex 25, GE HealthCare 31, Philips 32 ²⁸.

Under 21 CFR 807.40 a foreign establishment names one US Agent as part of its registration; the agent assists FDA with communications, questions and inspection scheduling, and changes to the agent's name, address or phone number are reported within 10 business days ²⁹. The agent owns neither the registration nor the listings nor any 510(k), De Novo or PMA. A change is made by the establishment in FDA's registration system, and the new agent confirms by email within 10 business days ³⁰. Nothing in the rule gives the outgoing agent a hold over the file.

What it takes to move a licence: three transfer regimes

Outside the EU and the US, the transfer rules decide whether a distributor-held registration is recoverable. Reading the current authority pages for sixteen jurisdictions, the mechanisms sort into three regimes, mapped below with the fee, the published processing time and how far the incumbent has to cooperate.

Regime A: changing the representative preserves the product authorization (US, Canada, EU)

The local representative here is an appointee, not an owner. In the US, registration and listing belong to the foreign establishment; the agent change has no government fee and takes effect once the new agent confirms ²⁹³⁰. In Canada, the licence is the manufacturer's and the importer holds an establishment licence; a new importer needs its own establishment licence, and the manufacturer's licence is untouched ²³²⁴. In the EU, the manufacturer holds the documentation and the certificate; the representative change follows the Article 12 agreement, and the guidance provides for a bilateral agreement when the outgoing representative is unavailable ²⁶²⁷.

Regime B: a transfer procedure exists, and it needs the incumbent (Singapore, Malaysia, Australia, Brazil, Mexico, Taiwan)

These authorities publish change procedures that ordinarily preserve the existing authorization when their conditions are met. The ordinary routes require incumbent documents, while exceptional circumstances and accompanying product changes can alter the process.

Singapore's Health Sciences Authority handles a change of registrant under GN-24-R2 (July 2025). The accepting company applies with a letter of request from the product owner and a form completed by the relinquishing company; supply and complaint records pass to the new registrant, and the relinquishing company gets no refund of its annual retention fee ¹⁵¹⁶. The fee is S$880 and the published turnaround is 40 working days ¹⁵¹⁶. The route described in the guidance depends on the relinquishing company's form.

Malaysia's Medical Device Authority handles a change of ownership under MDA/GD/0041. The new authorised representative applies with its establishment licence, a letter of authorisation from the manufacturer and a manufacturer letter giving the appointment date and the device list; the current representative completes a declaration, surrenders the certificates and hands over distribution and complaint records ¹⁷. The fee is RM 500 per registration ID, the target is about 30 working days, and the registration keeps its original validity ¹⁷. Without the current representative's declaration the file described in the guidance is incomplete.

Australia's Therapeutic Goods Administration accepts a notification of transfer of sponsorship signed by the former and the new sponsor, charges no fee and usually updates the ARTG within 10 working days ¹⁸. The same page states: "You cannot use the form to transfer sponsorship without the consent of the current sponsor" and adds that third parties such as manufacturers have no lawful power to transfer the sponsorship of an ARTG entry to another person ¹⁸. The alternative is a new ARTG entry under the new sponsor, which the TGA allows for the same product with the same manufacturer ¹⁸.

Brazil's ANVISA governs the transfer of registration ownership under RDC 903/2024, which replaced RDC 102/2016 without changing the procedure. The outgoing holder files a cancellation petition and the incoming holder files a transfer petition, concurrently and within 180 days of the corporate or commercial operation that caused the change ³¹. The procedure presupposes such an operation and the outgoing holder's petition; without them the new holder registers afresh.

Mexico's COFEPRIS processes a cession of rights over the sanitary registration as an administrative modification, trámite COFEPRIS-2022-022-005-A, with a published digital time of 22 business days and a government fee under the federal fee law ³². The assignee files, and the assignor's cession is the document the file turns on.

Taiwan treats a change of licence holder as a licence variation under the regulations on licence issuance, listing and annual declaration. The transferor and transferee apply jointly, with the transferee's dealer licence and a letter from the foreign manufacturer that terminates the transferor's registration right and names the transferee; the letter is valid for one year from issue ³³³⁴. Without a joint application the new firm applies for its own licence.

Regime C: budget a new filing or establish the available change route

Appointment-dependent files need a different continuity plan. Distinguish a documented new-filing requirement from an issuance page that is simply silent about transfers; silence is not proof that transfer is prohibited.

In Indonesia the registrant of an imported device is a licensed distributor or appointed representative named in the manufacturer's letter of authorisation. The registration guidelines set the appointment term at two to five years, and the marketing authorisation's validity follows that term ²². Pure Global's Indonesia market page states that one local representative is permitted per device and that changing it requires cancelling the authorisation and applying again, with registration fees by class from IDR 1.5 million to IDR 5 million Indonesia medical device registration. Use a new-filing contingency for that scenario and confirm the current KEMKES procedure before ending the existing appointment.

In the UAE the Emirates Drug Establishment issues the marketing authorisation on a file that includes the agency contract between the manufacturer and the local agent, with a published completion time of 45 working days and fees of AED 100 for the application and AED 5,000 for the registration ³⁵. The agency contract establishes a document dependency. This issuance service page does not settle whether the exact proposed agent change can use a variation; obtain EDE's route before budgeting cancellation or a supply gap.

In Vietnam the consolidated Decree 98 allows three kinds of registration holder: a Vietnamese enterprise that owns the device, a Vietnamese enterprise authorised by the owner, or the owner's resident representative office ³⁶. The registration number is revoked when the holder ceases operations or is no longer authorised by the owner and no replacement has been arranged, subject to the continuity rules in Article 37; the newly authorised holder declares or registers under its own name ³⁶.

In Israel the registration holder is an Israeli entity, normally the importer, and the Ministry of Health's procedure asks the holder for its own ISO 9001 or GMP certificate alongside the manufacturer's documents ³⁷. The cited registration checklist establishes the holder's documents, rather than the full rules for changing an existing holder. Israel also publishes a change-of-registration procedure; assess the proposed change under the current AMAR process before assuming a fresh application. ³⁸

Egypt has a published route for one direction of change: the variation guideline lists the documents for transferring a registration licence from an agent or distributor to a scientific office, with manufacturer authorisation letters at the centre ³⁹. The page is silent on a transfer between two independent distributors.

Between the regimes: Hong Kong and Colombia

Hong Kong's listing system is administrative and the Local Responsible Person is designated by the manufacturer. Under GN-10:2026, transferring the LRP is a major change: the incoming party submits a Takeover Application in MDIS, and implementation requires approval ⁴⁰⁴¹⁴². Colombia's Decree 4725 separates the registration holder from the importer, and INVIMA's register shows foreign manufacturers named as holders with local importers listed as roles ^{43891011121314}. Where the manufacturer is the holder, changing the importer is a modification; where the distributor is the holder, Colombia behaves like a consent market.

Choosing the holder for each market

The regime, not the distributor, should set the structure. The table translates the three regimes into a holder recommendation, the conditions under which a distributor-held file is acceptable, and the contract terms to add when it is.

Our judgment for appointment-dependent markets is to price commercial separation before the first filing. Where a holder change requires a fresh application, an independent holder can preserve continuity when distributors change. Where a variation is available, compare its conditions and timing. The same assessment must cover an eventual change of independent holder.

Our judgment on Regime B markets: a distributor-held registration is workable only if the transfer documents are agreed before the first filing. That means the distribution agreement obliges the distributor to sign the authority's relinquishing or declaration forms on request, to deliver copies of certificates and correspondence when issued, and to cooperate with records handover, with a defined response time and remedies. A prospective distributor that refuses those terms has answered the holder question.

Our judgment on Regime A markets: the representative role alone creates less regulatory ownership dependence, so prioritize responsiveness, competence, direct records access and a usable transition agreement. A US Agent or EU representative that forwards every authority contact the same day is worth more than the cheapest line.

How much does an independent in-country holder cost in each market?

The transfer fee is only one line in this decision. Singapore's change of registrant costs S$880, Malaysia's change of ownership RM 500 per registration, the UAE's marketing authorisation AED 5,000 plus AED 100, and Australia's sponsor transfer nothing ^1516173518. The expensive part of a distributor dispute is the time without a valid file, the legal effort to obtain a signature, or a second dossier.

Pure Global publishes its in-country representation fees. On its in-country representation page it describes the roles it takes, including US Agent, EU Authorised Representative, UK Responsible Person, registration holder, local applicant and sponsor, across 32 markets listed in September 2026 In-Country Representation. Its US Agent page states that the agent receives and forwards FDA communications, helps schedule inspections and answers questions about the establishment's devices, and that the role excludes post-market surveillance and the submission of regulatory documents US FDA Agent for medical device companies. Its Indonesia page describes the local representative holding the marketing authorisation and the distribution licence it needs Indonesia medical device registration.

The fees track market and risk class, not device type. The US Agent line is USD 1,000 per year for all classes and includes establishment registration support and processing of the annual FDA fee, which is payable separately Pricing. The EU Authorised Representative line is USD 2,000 per year for one device group and the UK Responsible Person line USD 2,000 for one registration; the Australian sponsor line is USD 2,000 for one registration on a CE reference approval Pricing.

In Singapore, Malaysia, Hong Kong, Brazil, Mexico and Colombia the first registration is USD 2,000 per year for the lower-risk classes and USD 3,000 for the higher-risk classes; Indonesia and Vietnam are USD 2,000 for all classes, with an Indonesian importation handling fee of 2% of import value (minimum USD 300, maximum USD 1,000) charged separately; Switzerland is USD 2,500 Pricing. The annual fee includes preparation and submission of the registration on a reference approval, modifications, renewals and correspondence with the authority Pricing. A three-year contract applies, early termination is possible against 50% of the remaining value, an annual contract carries a 50% higher first-year fee, and portfolios above ten devices are priced individually Pricing. Multi-registration and three-year-contract discounts apply. No approval or timeline is guaranteed.

One-time work is priced separately from the holder role. Regulatory pathway determination is a flat USD 5,000 per device or family; US 510(k) compilation is USD 15,000 to 20,000; the Canadian service lines range from USD 3,000 for Class I-related establishment work to USD 20,000 to 25,000 for Class IV compilation; Class I devices do not require an individual medical device licence; EU clinical evaluation report compilation is priced by class up to USD 30,000 Pricing. The dossier side of that budget is covered in the technical file cost guide, and the evidential limits of a register entry in the registration verification guide Medical device technical file compilation cost (2026)Medical device registration verification (2026).

The worked example is one Class C or Class III device held independently in four markets: US Agent USD 1,000, Australian sponsor USD 2,000, Singapore registrant at Class C USD 3,000 and Brazil registration holder at Class III USD 3,000, a flat USD 9,000 per year Pricing. With lower-risk classes in Singapore and Brazil the total is USD 7,000. Government fees, testing, translations from languages other than English and dossier compilation are outside these lines.

Two markets sit outside the representation table. Canada has no representative line because the manufacturer holds the licence; the list carries compilation lines only Pricing²³²⁴. Japan's marketing authorisation holder role is absent from the published list and is quoted on request Pricing.

Source: Pure Global Master Price List, 2026, checked against the public pricing page on 12 September 2026 Pricing.

Methodology and limits

The holder analysis used public snapshots of thirteen national registers taken between 2 and 12 September 2026: Indonesia (imported AKL authorisations), Singapore, Australia, Brazil, Taiwan (active licences), the UAE, Israel, Hong Kong (valid listings), Canada (active licences), Malaysia, Mexico, Vietnam and Colombia (valid registrations) ^{1234567891011121314}. The unit is one registration, deduplicated on the registration or licence number; Colombian role rows were grouped by registration and Canadian device rows were rolled up to licences. The foreign cohort is defined by the recorded manufacturer country or address.

Affiliation between holder and manufacturer was estimated from names after removing punctuation and legal suffixes: equal names, containment, or a shared first distinctive word count as one family, with generic words such as medical, healthcare and surgical excluded. Holder type used manual labels for the thirty largest holders in each market (360 labels) and a keyword rule for the rest; the residual is reported as unclassified. Holder breadth counts the distinct foreign manufacturers a holder represents in the same register.

Four limits matter for reading the numbers. Egypt's public table has no holder column and was left out. Malaysia, Mexico and Vietnam publish the holder but not the manufacturer, so only concentration is reported. Taiwan and Israel record holders and manufacturers in different scripts, so affiliation was left uncomputed. Brazil's export includes 17,407 of 103,065 rows without a status value, which were retained; the UAE source is a product directory with a supplier field rather than a formal holder register ^{1234567891011121314}.

The EU analysis read all 2,926,029 records of the EUDAMED public device export (snapshot 25 July 2026); records are UDI-DI rows, not devices, and non-EU status follows the manufacturer registration number's country prefix ²⁵. The US analysis combined FDA's registration and listing export of 22 July 2026 (419,651 rows) with bounded openFDA queries on 12 September 2026; listing records and establishments are reported separately because one establishment can carry hundreds of listings, and the two snapshots differ by six weeks ²⁸.

Transfer fees, processing times and procedural requirements are the authorities' published figures on 12 September 2026 and are quoted with their conditions; several authorities publish no fixed time ^{151617232426291831323334223536373940414243}.

Frequently asked questions

Can a foreign manufacturer hold its own registration?

In most of the markets reviewed here, no. Singapore, Malaysia, Indonesia, Australia, Brazil, Mexico, Taiwan, Vietnam and the UAE require the registrant, representative, sponsor or holder to be an entity established in the country ^{1516172218313233343635}. Canada provides a manufacturer-held model: the manufacturer applies for and holds the licence wherever it is based ²³²⁴. Colombia's register shows foreign manufacturers named as holders with a local importer as a role ^{43891011121314}. In the US and the EU the manufacturer holds the clearance or certificate and the documentation and appoints a US Agent or an authorised representative ²⁹²⁶.

Can a distributor refuse to hand over the registration?

In consent-based markets, yes in practice. The TGA states that sponsorship cannot be transferred without the current sponsor's consent and that manufacturers cannot transfer it themselves ¹⁸. Singapore's and Malaysia's procedures both require a form from the relinquishing holder, Brazil's requires the outgoing holder's cancellation petition, Mexico's requires the assignor's cession and Taiwan's requires a joint application ^{15161731323334}. Where the distributor will not sign, the routes left are a commercial settlement or a new registration under a new holder. Where a new filing is needed, plan records and stock continuity separately. In the US, Canada and EU the representative or distributor role alone does not confer ownership of the product authorization; portal access, documents and any separately held ownership can still create a dispute ^29232426.

Is a US Agent the same as a registration holder?

No. Under 21 CFR 807.40 the US Agent is a liaison: it helps FDA communicate with the foreign establishment, answers questions about the establishment's imported devices and assists with inspection scheduling ²⁹. It does not own the establishment registration, the device listings or any premarket clearance, and the establishment can name a different agent through FDA's registration system, with the new agent confirming by email ³⁰US FDA Agent for medical device companies. A registration holder in Indonesia, Brazil or the UAE, by contrast, is the party the authorisation is issued to.

For a market-by-market comparison of the actual holder, exit documents and annual cost, discuss your registration portfolio with Pure Global. Bring the current certificates, appointments and distribution agreements so the transition plan can address the existing files.

References

1. Info Alkes — Asia-Pacific national registers: Indonesia Ministry of Health, Info Alkes; Health Sciences Authority (Singapore), Singapore Medical Device Register; Therapeutic Goods Administration (Australia), Australian Register of Therapeutic Goods; Taiwan Food and Drug Administration, Medical device licence open data; Hong Kong Department of Health, MDACS list of listed medical devices; Medical Device Authority (Malaysia), Malaysian Medical Device Register; Vietnam Infrastructure and Medical Device Administration, Public registration publications; Pure Global analysis of snapshots taken 2 to 12 September 2026, accessed 12 September 2026. Supports third-party holding, single-holder dependence, multi-principal holding and concentration figures for Asia-Pacific markets. infoalkes.kemkes.go.id ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩
2. Singapore Medical Device Register — Asia-Pacific national registers: Indonesia Ministry of Health, Info Alkes; Health Sciences Authority (Singapore), Singapore Medical Device Register; Therapeutic Goods Administration (Australia), Australian Register of Therapeutic Goods; Taiwan Food and Drug Administration, Medical device licence open data; Hong Kong Department of Health, MDACS list of listed medical devices; Medical Device Authority (Malaysia), Malaysian Medical Device Register; Vietnam Infrastructure and Medical Device Administration, Public registration publications; Pure Global analysis of snapshots taken 2 to 12 September 2026, accessed 12 September 2026. Supports third-party holding, single-holder dependence, multi-principal holding and concentration figures for Asia-Pacific markets. data.gov.sg ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩
3. Australian Register of Therapeutic Goods — Asia-Pacific national registers: Indonesia Ministry of Health, Info Alkes; Health Sciences Authority (Singapore), Singapore Medical Device Register; Therapeutic Goods Administration (Australia), Australian Register of Therapeutic Goods; Taiwan Food and Drug Administration, Medical device licence open data; Hong Kong Department of Health, MDACS list of listed medical devices; Medical Device Authority (Malaysia), Malaysian Medical Device Register; Vietnam Infrastructure and Medical Device Administration, Public registration publications; Pure Global analysis of snapshots taken 2 to 12 September 2026, accessed 12 September 2026. Supports third-party holding, single-holder dependence, multi-principal holding and concentration figures for Asia-Pacific markets. tga.gov.au ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩
4. Medical device licence open data — Asia-Pacific national registers: Indonesia Ministry of Health, Info Alkes; Health Sciences Authority (Singapore), Singapore Medical Device Register; Therapeutic Goods Administration (Australia), Australian Register of Therapeutic Goods; Taiwan Food and Drug Administration, Medical device licence open data; Hong Kong Department of Health, MDACS list of listed medical devices; Medical Device Authority (Malaysia), Malaysian Medical Device Register; Vietnam Infrastructure and Medical Device Administration, Public registration publications; Pure Global analysis of snapshots taken 2 to 12 September 2026, accessed 12 September 2026. Supports third-party holding, single-holder dependence, multi-principal holding and concentration figures for Asia-Pacific markets. data.gov.tw ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩
5. MDACS list of listed medical devices — Asia-Pacific national registers: Indonesia Ministry of Health, Info Alkes; Health Sciences Authority (Singapore), Singapore Medical Device Register; Therapeutic Goods Administration (Australia), Australian Register of Therapeutic Goods; Taiwan Food and Drug Administration, Medical device licence open data; Hong Kong Department of Health, MDACS list of listed medical devices; Medical Device Authority (Malaysia), Malaysian Medical Device Register; Vietnam Infrastructure and Medical Device Administration, Public registration publications; Pure Global analysis of snapshots taken 2 to 12 September 2026, accessed 12 September 2026. Supports third-party holding, single-holder dependence, multi-principal holding and concentration figures for Asia-Pacific markets. mdis.mdd.gov.hk ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩
6. Malaysian Medical Device Register — Asia-Pacific national registers: Indonesia Ministry of Health, Info Alkes; Health Sciences Authority (Singapore), Singapore Medical Device Register; Therapeutic Goods Administration (Australia), Australian Register of Therapeutic Goods; Taiwan Food and Drug Administration, Medical device licence open data; Hong Kong Department of Health, MDACS list of listed medical devices; Medical Device Authority (Malaysia), Malaysian Medical Device Register; Vietnam Infrastructure and Medical Device Administration, Public registration publications; Pure Global analysis of snapshots taken 2 to 12 September 2026, accessed 12 September 2026. Supports third-party holding, single-holder dependence, multi-principal holding and concentration figures for Asia-Pacific markets. mdar.mda.gov.my ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩
7. Public registration publications — Asia-Pacific national registers: Indonesia Ministry of Health, Info Alkes; Health Sciences Authority (Singapore), Singapore Medical Device Register; Therapeutic Goods Administration (Australia), Australian Register of Therapeutic Goods; Taiwan Food and Drug Administration, Medical device licence open data; Hong Kong Department of Health, MDACS list of listed medical devices; Medical Device Authority (Malaysia), Malaysian Medical Device Register; Vietnam Infrastructure and Medical Device Administration, Public registration publications; Pure Global analysis of snapshots taken 2 to 12 September 2026, accessed 12 September 2026. Supports third-party holding, single-holder dependence, multi-principal holding and concentration figures for Asia-Pacific markets. imda.moh.gov.vn ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩
8. Dados abertos, produtos para saúde — Americas, Middle East and Canada registers: ANVISA (Brazil), Dados abertos, produtos para saúde; Emirates Drug Establishment (UAE), Registered product directory; Israel Ministry of Health, AMAR medical-device register; Health Canada, Medical Devices Active Licence Listing; COFEPRIS (Mexico), Registros sanitarios de dispositivos médicos; INVIMA (Colombia), Registros sanitarios de dispositivos médicos on datos.gov.co; Egyptian Drug Authority, Public medical-device registration table; Pure Global analysis of snapshots taken 2 to 12 September 2026, accessed 12 September 2026. Supports third-party holding, single-holder dependence, concentration and Canadian licence-holder figures. dados.anvisa.gov.br ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩
9. Registered product directory — Americas, Middle East and Canada registers: ANVISA (Brazil), Dados abertos, produtos para saúde; Emirates Drug Establishment (UAE), Registered product directory; Israel Ministry of Health, AMAR medical-device register; Health Canada, Medical Devices Active Licence Listing; COFEPRIS (Mexico), Registros sanitarios de dispositivos médicos; INVIMA (Colombia), Registros sanitarios de dispositivos médicos on datos.gov.co; Egyptian Drug Authority, Public medical-device registration table; Pure Global analysis of snapshots taken 2 to 12 September 2026, accessed 12 September 2026. Supports third-party holding, single-holder dependence, concentration and Canadian licence-holder figures. services.ede.gov.ae ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩
10. AMAR medical-device register — Americas, Middle East and Canada registers: ANVISA (Brazil), Dados abertos, produtos para saúde; Emirates Drug Establishment (UAE), Registered product directory; Israel Ministry of Health, AMAR medical-device register; Health Canada, Medical Devices Active Licence Listing; COFEPRIS (Mexico), Registros sanitarios de dispositivos médicos; INVIMA (Colombia), Registros sanitarios de dispositivos médicos on datos.gov.co; Egyptian Drug Authority, Public medical-device registration table; Pure Global analysis of snapshots taken 2 to 12 September 2026, accessed 12 September 2026. Supports third-party holding, single-holder dependence, concentration and Canadian licence-holder figures. registries.health.gov.il ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩
11. Medical Devices Active Licence Listing — Americas, Middle East and Canada registers: ANVISA (Brazil), Dados abertos, produtos para saúde; Emirates Drug Establishment (UAE), Registered product directory; Israel Ministry of Health, AMAR medical-device register; Health Canada, Medical Devices Active Licence Listing; COFEPRIS (Mexico), Registros sanitarios de dispositivos médicos; INVIMA (Colombia), Registros sanitarios de dispositivos médicos on datos.gov.co; Egyptian Drug Authority, Public medical-device registration table; Pure Global analysis of snapshots taken 2 to 12 September 2026, accessed 12 September 2026. Supports third-party holding, single-holder dependence, concentration and Canadian licence-holder figures. health-products.canada.ca ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩
12. Registros sanitarios de dispositivos médicos — Americas, Middle East and Canada registers: ANVISA (Brazil), Dados abertos, produtos para saúde; Emirates Drug Establishment (UAE), Registered product directory; Israel Ministry of Health, AMAR medical-device register; Health Canada, Medical Devices Active Licence Listing; COFEPRIS (Mexico), Registros sanitarios de dispositivos médicos; INVIMA (Colombia), Registros sanitarios de dispositivos médicos on datos.gov.co; Egyptian Drug Authority, Public medical-device registration table; Pure Global analysis of snapshots taken 2 to 12 September 2026, accessed 12 September 2026. Supports third-party holding, single-holder dependence, concentration and Canadian licence-holder figures. gob.mx ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩
13. Registros sanitarios de dispositivos médicos on datos.gov.co — Americas, Middle East and Canada registers: ANVISA (Brazil), Dados abertos, produtos para saúde; Emirates Drug Establishment (UAE), Registered product directory; Israel Ministry of Health, AMAR medical-device register; Health Canada, Medical Devices Active Licence Listing; COFEPRIS (Mexico), Registros sanitarios de dispositivos médicos; INVIMA (Colombia), Registros sanitarios de dispositivos médicos on datos.gov.co; Egyptian Drug Authority, Public medical-device registration table; Pure Global analysis of snapshots taken 2 to 12 September 2026, accessed 12 September 2026. Supports third-party holding, single-holder dependence, concentration and Canadian licence-holder figures. datos.gov.co ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩
14. Public medical-device registration table — Americas, Middle East and Canada registers: ANVISA (Brazil), Dados abertos, produtos para saúde; Emirates Drug Establishment (UAE), Registered product directory; Israel Ministry of Health, AMAR medical-device register; Health Canada, Medical Devices Active Licence Listing; COFEPRIS (Mexico), Registros sanitarios de dispositivos médicos; INVIMA (Colombia), Registros sanitarios de dispositivos médicos on datos.gov.co; Egyptian Drug Authority, Public medical-device registration table; Pure Global analysis of snapshots taken 2 to 12 September 2026, accessed 12 September 2026. Supports third-party holding, single-holder dependence, concentration and Canadian licence-holder figures. eservicesdata.edaegypt.gov.eg ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩
15. GN-24-R2 Guidance on the Change of Registrant (July 2025) — Health Sciences Authority (Singapore), GN-24-R2 Guidance on the Change of Registrant (July 2025) and Fees and turnaround time for medical devices, accessed 12 September 2026. Supports the change-of-registrant documents, the S$880 fee and the 40-working-day turnaround. hsa.gov.sg ↩ ↩ ↩ ↩ ↩ ↩ ↩
16. Fees and turnaround time for medical devices — Health Sciences Authority (Singapore), GN-24-R2 Guidance on the Change of Registrant (July 2025) and Fees and turnaround time for medical devices, accessed 12 September 2026. Supports the change-of-registrant documents, the S$880 fee and the 40-working-day turnaround. hsa.gov.sg ↩ ↩ ↩ ↩ ↩ ↩ ↩
17. MDA/GD/0041 Change of Ownership for Medical Device Registration, First Edition, December 2016 — Medical Device Authority (Malaysia), MDA/GD/0041 Change of Ownership for Medical Device Registration, First Edition, December 2016, accessed 12 September 2026. Supports the change-of-ownership documents, the current representative's declaration, the RM 500 fee per registration ID and the 30-working-day target. mda.gov.my ↩ ↩ ↩ ↩ ↩ ↩ ↩
18. Changing the sponsor of a therapeutic good — Therapeutic Goods Administration, Changing the sponsor of a therapeutic good, accessed 12 September 2026. Supports the transfer notification, the absence of a fee, the 10-working-day update and the quoted consent statements. tga.gov.au ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩
19. Latin American Medical Device Regulations — Patricia M. Flood, Latin American Medical Device Regulations, Medical Device and Diagnostic Industry, 1 July 2000, accessed 12 September 2026. Supports the quoted description of distributor-held registrations and re-registration on a change of distributor. mddionline.com ↩
20. WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices — World Health Organization, WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices, 5 September 2017, accessed 12 September 2026. Supports the role definitions of manufacturer, authorised representative, importer and distributor. who.int ↩
21. Latin America Market Entry Strategies for Medical Device Companies — ComplianceOnline, Latin America Market Entry Strategies for Medical Device Companies, accessed 12 September 2026. Supports the comparison of subsidiary, distributor-held and representative-held registrations. complianceonline.com ↩
22. Pedoman registrasi izin edar — Ministry of Health (Indonesia), Pedoman registrasi izin edar, accessed 12 September 2026. Supports the letter-of-authorisation requirement and the link between the appointment term and the authorisation's validity. regalkes.kemkes.go.id ↩ ↩ ↩ ↩
23. Medical Devices Regulations, SOR/98-282 — Government of Canada, Medical Devices Regulations, SOR/98-282 and Canada Gazette, Part II, SOR/2026-110, accessed 12 September 2026. Supports the manufacturer-held licence (sections 26 and 32), establishment licences (section 44) and the 14 December 2026 amendment. laws-lois.justice.gc.ca ↩ ↩ ↩ ↩ ↩ ↩ ↩
24. Canada Gazette, Part II, SOR/2026-110 — Government of Canada, Medical Devices Regulations, SOR/98-282 and Canada Gazette, Part II, SOR/2026-110, accessed 12 September 2026. Supports the manufacturer-held licence (sections 26 and 32), establishment licences (section 44) and the 14 December 2026 amendment. gazette.gc.ca ↩ ↩ ↩ ↩ ↩ ↩ ↩
25. EUDAMED public device records — European Commission, EUDAMED public device records, snapshot 25 July 2026; Pure Global analysis, accessed September 2026. Supports the authorised-representative presence and concentration figures. ec.europa.eu ↩ ↩ ↩ ↩ ↩
26. Regulation (EU) 2017/745 on medical devices — European Parliament and Council, Regulation (EU) 2017/745 on medical devices, Articles 11 and 12, accessed 12 September 2026. Supports the mandate requirements and the change-of-representative agreement. eur-lex.europa.eu ↩ ↩ ↩ ↩ ↩ ↩
27. MDCG 2022-16 Guidance on Authorised Representatives — Medical Device Coordination Group, MDCG 2022-16 Guidance on Authorised Representatives, October 2022, accessed 12 September 2026. Supports the tripartite-agreement expectation and its exceptions. health.ec.europa.eu ↩ ↩
28. Device Registration and Listing API — openFDA, Device Registration and Listing API, metadata 31 August 2026, and FDA registration and listing export of 22 July 2026; Pure Global analysis, accessed September 2026. Supports the US Agent record and establishment counts. open.fda.gov ↩ ↩ ↩ ↩ ↩ ↩
29. 21 CFR § 807.40 Establishment registration and device listing for foreign establishments — Legal Information Institute, 21 CFR § 807.40 Establishment registration and device listing for foreign establishments, accessed 12 September 2026. Supports the single-agent requirement, the agent's duties and the 10-business-day change notice. law.cornell.edu ↩ ↩ ↩ ↩ ↩ ↩
30. U.S. Agents — Food and Drug Administration, U.S. Agents, accessed 12 September 2026. Supports the agent confirmation process in FDA's registration system. fda.gov ↩ ↩ ↩
31. Resolução da Diretoria Colegiada, RDC nº 903, de 6 de setembro de 2024 — ANVISA, Resolução da Diretoria Colegiada, RDC nº 903, de 6 de setembro de 2024, accessed 12 September 2026. Supports the concurrent transfer and cancellation petitions within 180 days. anvisalegis.datalegis.net ↩ ↩ ↩ ↩
32. Diario Oficial de la Federación, 24 January 2022, trámite COFEPRIS-2022-022-005-A — Secretaría de Salud (Mexico), Diario Oficial de la Federación, 24 January 2022, trámite COFEPRIS-2022-022-005-A, accessed 12 September 2026. Supports the cession of rights procedure and the 22-business-day time. dof.gob.mx ↩ ↩ ↩ ↩
33. Regulations for issuance of medical device licences, listing and annual declaration — Ministry of Health and Welfare (Taiwan), Regulations for issuance of medical device licences, listing and annual declaration and Center for Drug Evaluation, FAQ on change of licence holder, updated 20 November 2025, accessed 12 September 2026. Supports the joint application and manufacturer letter requirements. law.moj.gov.tw ↩ ↩ ↩ ↩
34. FAQ on change of licence holder, updated 20 November 2025 — Ministry of Health and Welfare (Taiwan), Regulations for issuance of medical device licences, listing and annual declaration and Center for Drug Evaluation, FAQ on change of licence holder, updated 20 November 2025, accessed 12 September 2026. Supports the joint application and manufacturer letter requirements. cde.org.tw ↩ ↩ ↩ ↩
35. Issuance of Marketing Authorization for a Medical Device — Emirates Drug Establishment, Issuance of Marketing Authorization for a Medical Device, accessed 12 September 2026. Supports the agency contract requirement, the AED 100 and AED 5,000 fees and the 45-working-day time. ede.gov.ae ↩ ↩ ↩ ↩
36. Consolidated Document No. 08/VBHN-BYT on the management of medical devices, 6 March 2026 — Ministry of Health (Vietnam), Consolidated Document No. 08/VBHN-BYT on the management of medical devices, 6 March 2026, accessed 12 September 2026. Supports the holder eligibility rules (Article 25), the continuity rules (Article 37) and the revocation ground (Article 38). datafiles.chinhphu.vn ↩ ↩ ↩ ↩
37. Procedure for registration in the medical equipment register — Ministry of Health (Israel), Procedure for registration in the medical equipment register, accessed 12 September 2026. Supports the registration holder's document requirements. gov.il ↩ ↩
38. Procedure for changing registration in the medical equipment register — Israel Ministry of Health, Procedure for changing registration in the medical equipment register, identified in the Ministry's current procedure collection, September 13, 2026. A separate change procedure exists; eligibility for a specific holder change requires checking its full current terms. gov.il ↩
39. Regulatory Guideline of the Procedures and Rules Organizing the Changes Done to a Registration License Data of a Medical Device, GL.CAMD.003 v3 — Egyptian Drug Authority, Regulatory Guideline of the Procedures and Rules Organizing the Changes Done to a Registration License Data of a Medical Device, GL.CAMD.003 v3, accessed 12 September 2026. Supports the transfer route from an agent or distributor to a scientific office. edaegypt.gov.eg ↩ ↩
40. GN-01 Overview of the Medical Device Administrative Control System — Department of Health (Hong Kong), GN-01 Overview of the Medical Device Administrative Control System and Code of Practice for Local Responsible Persons (September 2026) and GN-10:2026 Guidance Notes for Changes of Listed Medical Devices, verified 13 September 2026. COP-01 section 1.2 supports LRP eligibility; GN-10 sections 3.2 and 5.1.3 support approval before implementing an LRP transfer and the incoming party’s Takeover Application. mdd.gov.hk ↩ ↩
41. Code of Practice for Local Responsible Persons (September 2026) — Department of Health (Hong Kong), GN-01 Overview of the Medical Device Administrative Control System and Code of Practice for Local Responsible Persons (September 2026) and GN-10:2026 Guidance Notes for Changes of Listed Medical Devices, verified 13 September 2026. COP-01 section 1.2 supports LRP eligibility; GN-10 sections 3.2 and 5.1.3 support approval before implementing an LRP transfer and the incoming party’s Takeover Application. mdd.gov.hk ↩ ↩
42. GN-10:2026 Guidance Notes for Changes of Listed Medical Devices — Department of Health (Hong Kong), GN-01 Overview of the Medical Device Administrative Control System and Code of Practice for Local Responsible Persons (September 2026) and GN-10:2026 Guidance Notes for Changes of Listed Medical Devices, verified 13 September 2026. COP-01 section 1.2 supports LRP eligibility; GN-10 sections 3.2 and 5.1.3 support approval before implementing an LRP transfer and the incoming party’s Takeover Application. mdd.gov.hk ↩ ↩
43. Decreto 4725 de 2005 — INVIMA, Decreto 4725 de 2005, accessed 12 September 2026. Supports the holder and importer roles and the modification procedure. normograma.invima.gov.co ↩ ↩ ↩