Medical Device Registration in Singapore

Singapore’s chief medical regulatory body is the Health Sciences Authority (HSA). In 2007, the HSA passed the Health Products Act, allowing them to conduct mandatory product registration and regulate the supply, distribution, manufacturing, import, and advertisement of all health products. Registered medical devices are listed on the Singapore Medical Device Register (SMDR), which is publicly available on the HSA’s website.

• Health Canada (HC)
• Japan Ministry of Health Labor & Welfare (MHLW)
• United States Food & Drug Administration (US FDA)
• Therapeutic Goods Administration/European Union Notified Bodies (TGA/EU NB)

Yes, medical devices require registration before they can be sold.

Medical devices are classified into 4 risk classes:

• Class A: Low Risk (ex. surgical retractors, tongue depressors)
• Class B: Low-moderate Risk (ex. hypodermic needles, suction equipment)
• Class C: Moderate-high Risk (ex. lung ventilator, bone fixation plate)
• Class D: High Risk (ex. heart valves, implantable defibrillator)

Class A Non-Sterile Devices

• Class A non-sterile medical devices are exempt from registration and do not need to be registered with the HSA prior to being placed on the market. However, Class A non-sterile medical devices require a local agent in Singapore with appropriate wholesaler/importer licenses.
• Even though Class A non-sterile devices do not require registration with the HSA, they still must conform to the Essential Principles for Safety and Performance for Medical Devices prior to going on the Singapore market.

Class A Sterile Devices

• Step 1: Submission of application dossier via the Medical Device Information and Communication System (MEDICS) – The product application fee is immediately charged upon application submission.
• Step 2: Review of application dossier – The review conducted by the HSA is based on the supporting data, which the applicant submitted. If clarification or additional information is required, the HSA will issue the applicant a request.
• Step 3: Regulatory decision and listing on the SMDR for successful registration – Upon review of the application submitted, a regulatory decision is made by the HSA. Applications that satisfied the registration requirements are then registered and listed on the SMDR.

Approval Timeline: 1 month

Class B Medical Devices

• There are 4 evaluation routes for Class B Medical Devices:
  1. Full Evaluation Route – A medical device that has not obtained any prior approval from any of HSA’s reference regulatory agencies at the pint of application will be subject to the full evaluation route.
  2. Abridged Evaluation Route – To qualify, a medical device must have obtained at least one regulatory agency approval for a labeled use identical to the one intended for marketing in Singapore at the time of submission.
  3. Expedited Class B Registration (EBR) Evaluation Route
     • To qualify for EBR1, at the time of the submission the medical device must fit the following criteria:
       1. Have approval from at least one of HSA’s independent reference regulatory agencies for a labeled use identical to the one intended for marketing in Singapore.
       2. Marketed for at least three years in the above independent reference regulatory agency’s jurisdiction.
       3. No safety issues globally associated with the use of the medical device when used as intended by the Product Owner in the last three years.
     • To qualify for EBR2, at the time of submission the medical device must have obtained approvals from at least two of HSA’s independent reference regulatory agencies for a labeled use identical to that intended for marketing in Singapore.
  4. Immediate Class B Registration (IBR) Evaluation Route
     • To qualify for the IBR evaluation route, at the time of the submission the medical device must fit the following criteria:
       1. Have approval from at least two of HSA’s independent reference regulatory agencies for a labeled use identical to the one intended for marketing in Singapore.
       2. Marketed for at least three years in two of the above independent reference regulatory agencies’ jurisdiction.
       3. No safety issues globally associated with the use of the medical device when used as intended by the Product Owner in the last three years.
       4. No rejection/withdrawal of the medical device by/from any reference regulatory agency/that foreign jurisdiction(s) or HSA/Singapore due to quality, performance/efficacy or safety issues.
• Process for Evaluation Routes (1-3) Above:
  1. Submission of application via MEDICS
  2. Verification of Application
  3. Evaluation of Application
  4. Regulatory decision and listing on SMDR for successful registration
• Process for the IBR Evaluation Route
  1. Successful submission of application via MEDICS
  2. Device is registered and listed on SMDR
  3. Verification of Documents

Class C & D Medical Devices

• There are 3 evaluation routes for Class C & D Medical Devices:
  1. Full Evaluation Route (qualifications as defined above)
  2. Abridged Evaluation Route (qualifications as defined above)
  3. Expedited Evaluation Route
     • Expedited Class C Registration (ECR) – same qualifications as for EBR
     • Expedited Class D Registration (EDR) – To qualify for EDR, the device must have obtained approvals from at least two of HSA’s independent reference regulatory agencies for a labeled use identical to that intended for marketing in Singapore. The following devices do not qualify for EDR: active implantable devices; implantable devices in direct contact with the central nervous system; hip, knee and shoulder joint replacements; devices incorporating a registrable drug in an ancillary role, IVD devices intended for HIV testing or blood/tissue donor compatibility testing.
• Process for Evaluation Routes (1-3) Above
  1. Submission of application via MEDICS
  2. Verification of Application
  3. Evaluation of Application
  4. Regulatory decision and listing on SMDR for successful registration

Class A (Sterile)

1. Letter of Authorization
2. Proposed Device Labeling
3. IFU, patient information leaflet and promotional material (including brochures and catalogues)
4. A list of all materials of animal, human, microbial and/or recombinant origin used and manufacturing process if applicable
5. Sources of all materials of animal, human, microbial and/or recombinant origin used and manufacturing process (if applicable)
6. Information on sterilization method(s) and validation standard(s) used
7. Proof of Quality Management System (QMS) – E.g. ISO 13485 certificate, conformity to US FDA Quality System Regulations, Japan MHLW Ordinance 169 or attestation stating adequate QMS

Class B, C, & D

1. Letter of Authorisation
2. Annex 2 List of Configurations
3. Proof of reference agency’s approval(s)
4. Proof of marketing history in the reference agencies’ jurisdictions (e.g. invoice with date, proof of sale, or a declaration on marketing history)
5. Declaration of no safety issues globally
6. Executive Summary
7. Essential Principles Checklist and Declaration of Conformity
8. Device Description
9. Design verification and validation documents
10. Clinical Evidence
11. Proposed Device Labeling
12. Risk Analysis
13. Manufacturer Information (site’s name and address)
14. Proof of Quality Management System (QMS) – E.g. ISO 13485 certificate, conformity to US FDA Quality System Regulations, Japan MHLW Ordinance 169
15. Manufacturing Process – Flow Chart

No, local testing is not required for registration in Singapore.

No, clinical studies are generally not required for registration in Singapore.

No, approval in the Country of Origin is not required for registration in Singapore.