HSA Singapore Medical Device Registration

Medical devices sold in Singapore are regulated by the Health Sciences Authority (HSA). The main medical device regulation in Singapore is the Health Products (Medical Devices) Regulations 2010. All medical devices except Class A devices require product registration with the HSA and are listed in the Singapore Medical Device Register (SMDR).

Manufacturers, wholesalers, and importers of medical devices must also obtain the appropriate license, known as a dealer’s license. This applies to all device classes, including Class A.

HSA medical device classification

Medical devices in Singapore are classified into four categories based on risk, informed by the ASEAN Medical Device Directive: Class A, B, C, and D. The device’s class determines the registration route and associated documentation requirements.

HSA medical device regulatory pathways

HSA supports numerous regulatory pathways with eligibility based on device classification, authorizations in other markets, and market history. Class A devices are exempt from registration. Most Class B, C, D devices are eligible for immediate, abridged, or expedited pathways if they have current authorizations from US FDA, EU (Notified Bodies under MDR/IVDR), Australia TGA, Health Canada, and Japan PMDA.

Class A Medical Devices (Exempt from Registration)

• Process: No product registration or review required. A product notification must be submitted via SHARE.

• Requirements: A valid HSA dealer’s licence (Manufacturer and/or Importer, and/or wholesaler, as applicable); foreign manufacturers need to appoint a Singapore Registrant.

• Documentation: Maintenance of an appropriate Quality Management System in accordance with dealer licensing requirements.

• Timeline: Immediate on submission.

• Renewal: Notification remains active as long as dealer’s license is maintained and annual fees are paid.

Class B, C, and D Medical Devices (Registration Required)

• Process: All Class B, C, and D devices must be registered with HSA via the SHARE portal. The registration route depends on the device’s classification, marketing and safety history, and prior approvals in reference markets (US, Canada, EU, Australia, Japan).

• Requirements: A valid HSA dealer’s licence (Manufacturer and/or Importer, and/or wholesaler, as applicable); foreign manufacturers need to appoint a Singapore Registrant.

• Documentation: Specific documentation requirements can vary by evaluation route, but can include: - Completed application form in SHARE. - Technical documentation, with scope and depth depending on the evaluation route. - Evidence of approval from overseas reference regulatory agencies (required for immediate, abridged, and expedited routes). - Valid ISO 13485 certificate or other acceptable QMS certification (MDSAP, Conformity to US FDA Quality System Regulations, or Japan MHLW Ordinance 169 are also accepted). - Labeling and Instructions for Use in English. - Letter of Authorisation, if submitted by a third party on behalf of the product owner. - List of device configurations. - Additional documents required for immediate, abridged, and expedited routes: Proof of marketing history and Declaration of no global safety issues.

• Timeline: Vary considerably by device classification and evaluation route.

• Renewal: Registrations remain active as long as supported dealer’s licenses and certifications are maintained and annual fees are paid.

Evaluation Routes and Turnaround Times for Class B, C, and D Devices

• Full Evaluation (Class B, C, D): No prior approval from any of HSA’s overseas reference regulatory agencies. Turnaround time is 160-310 working days.

• Full Evaluation Priority Review (Class B, C, D): No prior approval from any of HSA’s overseas reference regulatory agencies and fulfill criteria. Turnaround time is 104-202 working days. - Route 1(1): Belongs to one of five focused healthcare areas: Cancer, Diabetes, Ophthalmic diseases, Cardiovascular diseases, Infectious diseases. - Route 1(2): It is designed and validated for an unmet clinical need: i) No other existing treatment ii) Breakthrough technology. - Route 2: Does not meet Route 1 criteria.

• Abridged Evaluation (Class B, C, D): Approval from at least one overseas reference regulatory agency. Turnaround time is 100-220 working days.

• Expedited Class C Registration 1 (ECR-1): Approval and three years of marketing in one oversees reference market; no safety issues, withdrawals, or rejections. Turnaround time is 120 working days.

• Expedited Class C Registration 2 (ECR-2): Approval in two oversees reference markets; no withdrawals or rejections. Turnaround time is 120 working days.

• Expedited Class D Registration (EDR): Approval in two oversees reference markets; no withdrawals or rejections. Turnaround time is 180 working days.

• Immediate Class B Registration (IBR) - Condition 1: Approval and three years of marketing in one oversees reference market; no safety issues, withdrawals, or rejections. Immediate approval on submission.

• Immediate Class B Registration (IBR) - Condition 2: Approval in at least two oversees reference markets; no global safety issues, withdrawals, or rejections. Immediate approval on submission.

• Immediate approval for Standalone Medical Mobile Applications: Approval in at least one oversees reference market; no global safety issues, withdrawals, or rejections. Immediate approval on submission.

Other HSA registration requirements

• Local representative: Foreign manufacturers must appoint a Singapore-based registrant or license holder to submit device registration and manage regulatory communications with HSA. Must have a valid dealer’s license.

• Dealer's license: Required for all parties involved in importing or supplying medical devices regardless of device classification. Must be renewed annually. Foreign manufacturers do not need to hold a dealer’s license; this is maintained by their importer or Registrant.

• Translation: All submission documents and labeling/IFU must be in English.

• Quality system evidence: Vary depending on evaluation route and reference market. Note that acceptable QMS evidence is different for dealer’s license applications.

• Post-market obligations: Registrants and dealers are responsible for adverse event reporting, field safety corrective actions (FSCA), and maintaining distribution records. Vigilance reports must be submitted according to HSA timelines.

How Do I Obtain a Medical Device Dealer’s Licence in Singapore?

Companies must apply through the SHARE portal administered by the Health Sciences Authority (HSA). There are three types of dealer’s licences: Manufacturer’s Licence, Importer’s Licence, Wholesaler’s Licence.

Dealer’s license applicants must maintain an appropriate Quality Management System (QMS) certification for the duration of the licence. Proof of QMS certification is required with the application.

What documentation is required to register a medical device or IVD in Singapore?

Documentation depends on the classification and registration route:

For Class A (exempt devices):

• No product registration

• Dealer’s license required

• Compliance with labeling and safety regulations

For Class B, C, D (registered devices):

• Technical documentation in ASEAN Common Submission Dossier Template (CSDT) (required sections vary based on risk class and evaluation route)

• Evidence of reference agency approvals (approval letters or certificates)

• QMS Certificate (ISO 13485, MDSAP, Conformity to US FDA Quality System Regulations, or Japan MHLW Ordinance 169 are accepted)

• Labeling and IFU in English

• Letter of Authorization (if submitted by a third party)

• List of device configurations

• Proof of marketing history (required for some expedited and immediate routes)

• Declaration of no global safety issues (required for some expedited and immediate routes)

What is a Singapore Registrant and why do you need one?

A Singapore Registrant is a local entity authorized to register and/or market a medical device on behalf of a foreign manufacturer. This representative is responsible for submitting registration applications, maintaining licenses, and ensuring compliance with HSA requirements. All foreign manufacturers must designate a registrant in Singapore.

Do foreign manufacturers need a dealer’s license?

Device manufacturers not based in Singapore do not need to hold a dealer’s license. Their Singapore Registrant will hold a dealer’s license.