Simple, Transparent Pricing for Global Medical Device Registration
Accelerate market entry with AI-powered dossier compilation and local regulatory representation, all for a flat annual fee. Use our Fee Calculator to get your instant estimate with a few clicks.
Predictable Annual Fees
Starting at $2,000 USD per year for the first device (excluding government fees).
All-Inclusive Support
Dossier preparation and submission, in country representation, translation, modifications, distributor authorization, and post market support.
Turnkey Registration in Key Markets
Our flat fee pricing structure is offered in major medical device markets worldwide (special terms apply in some markets).
Calculate Your Price
Select your target markets, device classification, and number of devices to generate an instant estimate. Pricing updates automatically as you adjust your selections.
Flat annual fee by market
Pure Global charges a transparent flat annual fee that starts at $1,000/year and ranges from $1,000 to $3,000/year per device listing, depending on the market and device risk class, with lower per-device rates as you add more products. Government fees are billed separately. The figures below are the starting (single-device) annual fee — use the calculator above for an exact quote.
View the full fee table — 18 markets, all risk classes
| Market | Device class / risk | Flat annual fee (from) |
|---|---|---|
| Americas | ||
 Brazil | Low/Medium Risk | from $2,000/year |
| Medium/High Risk | from $3,000/year | |
 Colombia | Low/Medium Risk | from $2,000/year1 |
| Medium/High Risk | from $3,000/year1 | |
 Mexico | Class LR/I | from $2,000/year |
| Class II/III | from $3,000/year | |
 United States | All Classes | from $1,000/year6 |
| Europe | ||
 European Union | All Classes | from $2,000/year4 |
 Switzerland | All Classes | from $2,000/year7 |
 United Kingdom | All Classes | from $2,000/year5 |
| Asia Pacific | ||
 Australia | All Classes | from $2,000/year |
 Hong Kong | Class I/II (MD) | from $2,000/year8 |
| Class III/IV (MD) | from $3,000/year8 | |
| Class A/B (IVD) | from $2,000/year8 | |
| Class C/D (IVD) | from $3,000/year8 | |
 India | Class A | from $2,000/year9 |
| Class B/C/D | from $3,000/year9 | |
 Indonesia | All Classes | from $2,000/year |
 Macau | Class I/II | from $2,000/year |
| Class III / Class C/D | from $3,000/year | |
 Malaysia | Low/Medium Risk | from $2,000/year |
| Medium/High Risk | from $3,000/year | |
 Pakistan | All Classes | from $3,000/year |
 Philippines | All Classes | from $2,000/year |
 Singapore | Low/Medium Risk | from $2,000/year2 |
| Medium/High Risk | from $3,000/year | |
 Thailand | Low/Medium Risk | from $2,000/year3 |
| Medium/High Risk | from $3,000/year3 | |
 Vietnam | All Classes | from $2,000/year |
- CCAA Importer certificate included, if required
- Class A products need to be imported by Pure Global; passthrough fees from service providers may apply
- Products need to be imported by Pure Global; importation and passthrough fees may apply
- Includes document review, CFS request support, and EUDAMED support. Government fees do not apply.
- Processing of CFS requests included. Passthrough fees from service providers may apply.
- Support with processing annual FDA fee included
- Based on CE reference market approval. Free sale certificate requests included. Government fees do not apply.
- There are no government fees in this market
- Importation fee applies when handled by the Indian Authorized Agent: 2% of import value, minimum $300 and maximum $1,000 per importation; importation agreement required
What's Included in Your Flat Annual Fee?
Everything you need for medical device & IVD registration.
Dossier Preparation
We compile and submit your dossier in half the time using our AI powered workflows and in house expertise (not included in some markets).
In-Country Representation
As your in country representative, local regulatory experts interface directly with health authorities on your behalf.
Translation Services
Dossier preparation includes localization from English for submission documents where required (excludes certified translations).
Modifications & Renewals
Compliant and on time filing for device modifications and registration renewals.
Importer Authorization
Generate import authorizations to local distributors and importers, where applicable.
Post-Market Support
Support for post market surveillance, vigilance, reporting, and ongoing regulatory obligations.
* Government fees not included
Government fees and other required third party fees are not included, but we can help you estimate these costs.
* Custom pricing for large portfolios
Registering more than 10 devices? We will create a custom pricing estimate for your needs.
* Three-year contract required
Early contract termination is possible with 50% payoff of the remaining contract value. If you prefer a one year contract, pay a 50% higher fee in the first year.
The Value of flat-fee pricing
After 20+ years in MedTech regulatory services, we believe pricing should be simple, fair, and transparent.
Budget with Confidence
Know exactly what you'll pay before you commit.
Compare Markets
Instantly evaluate market costs side-by-side.
Scale Efficiently
See pricing for 1 to 10 listings so you can plan your portfolio expansion.
Instant Self-Service
No need to wait for quotes. Get your pricing immediately.
Pricing Questions Answered
The flat annual fee includes:
- In-country regulatory representation
- Device registration compilation*
- Dossier submission to local authorities
- Translations from English to the local language for required submission documents
- Import authorizations for local distributors, where applicable
- Post-approval modifications
- Annual renewals
- Post-market surveillance correspondence with authorities
*Not included in the US, EU, UK, Switzerland, and Australia. Dossier compilation available separately for a fixed rate.
The following are excluded:
- Government and third-party fees
- Importation handling by the in-country representative
- Translations into English
- Marketing material translations
- Certified translations required by authorities
Medical device and IVD registration services start at $2,000 USD per year, depending on device risk level, number of listings, and selected markets.
Flat fee pricing is available for 14 global markets, including Brazil, Colombia, Mexico, the United States*, the European Union*, Switzerland*, the United Kingdom*, Australia*, Hong Kong, Indonesia, Malaysia, Singapore, Thailand, and Vietnam.
Pure Global supports 30+ global markets. Pricing for additional markets is customized based on regulatory scope.
*Flat fee pricing excludes dossier preparation in US, EU, UK, Switzerland, and Australia. Available separately for a fixed rate.
Your annual fee is based on:
- Number of device listings (1–10 standard)
- Device risk level (low/medium or medium/high)
- Selected markets
Portfolios with more than 10 listings require custom pricing.
No. Government fees and required third-party fees are not included in the annual fee and are billed separately.
Translations from English to the local language for regulatory submission documents are included.
The following are not included:
- Translations into English
- Marketing material translations
- Certified translations required by authorities
These services are available for an additional fee.
Yes. Where required, Pure Global serves as the authorized in-country representative and manages all regulatory correspondence with local authorities.
Yes. A three-year contract is required.
Yes. Early termination is permitted with a 50% payoff of the remaining contract value.
Yes. One-year contracts are available with a 50% higher fee in the first year.
Flat-fee pricing for the EU starts at $2,000 USD per year for one device group and scales to $4,000 USD for five device groups1. This fee includes:
- Ongoing regulatory representation under EU MDR or IVDR
- Review of prepared documentation
- Support with EUDAMED registration and maintenance2
- Free Sale Certificate (FSC) requests
Compilation of the Technical Documentation File is not included in the annual fee and is offered separately at a fixed rate.
1 Pricing structure also applies in the UK, Australia, and Switzerland.
2 MHRA Portal registration in the UK, ARTG registration in Australia, and Swissdamed registration in Switzerland are included in the annual fees for these markets.
Flat-fee pricing for the US starts at $1,000 USD per year and covers:
- Representation as your Official Correspondent and US Agent
- Support for FDA establishment registration
- Guidance on FDA annual user fee processing
Compilation of 510(k) or other premarket submissions are not included in the flat fee. These services are available separately at a fixed rate.