Singapore HSA
Singapore Medical Device Regulation
Regulatory Body: Medical Device Branch of the Health Sciences Authority (HSA)
Regulation: Health Products Act 2007 and Health Products (Medical Devices) Regulations 2010
Classification: Class A, B, C, and D
Representative (should be based in country or not): Yes, Authorized Representative is required.
Registration timeline: 100-310 days (depending on class & route)
Registration Pathway
There are mainly four routes of registration:
Medical device that has not got any prior approval from US, Europe, Canada, Australia, or Japan regulatory bodies at the point of registration application will be subject to full evaluation route. This route takes 160-310 days for device registration.
Devices with prior authorization in the US, Europe, Canada, Australia, or Japan are eligible for abridged evaluation routes. It takes 100-220 days depending on the class for registration under ECR.
This route ensures immediate registration upon submission. Devices should fulfil mentioned conditions to be eligible for this route.
It takes 120-180 days for registration under ECR. Devices should fulfil mentioned conditions to be eligible for this route.
Depending on the classification of the device one can apply for the applicable route.
- Class A: Class A devices do not need registration.
- Class B:
- (i) Full Evaluation Route
- (ii) Abridged Evaluation Route (device should be approved by at least 1 regulatory agency)
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(iii) Immediate Class B Registration (IBR) Evaluation Route
- Condition 1: Device should be approved by at least 1 regulatory agency & marketed for 3 years in the respective country. It should not have any safety issues & no prior withdrawal/rejection from any other regulatory body.
- Condition 2: Device should be approved by at least 2 regulatory agencies. It should not have any safety issues & no prior withdrawal/rejection from any other regulatory body.
- The device should fulfil at least one condition to be eligible for IBR.
- Class C and Class D:
- (i) Full Evaluation Route
- (ii) Abridged Evaluation Route (device should be approved by at least 1 regulatory agency)
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(iii) Expedited Evaluation Route
- a. Expedited Class C Registration (ECR)
- Condition 1: Device should be approved by at least 1 regulatory agency & marketed for 3 years in the respective country. It should not have any safety issues & no prior withdrawal/rejection from any other regulatory body.
- Condition 2: Device should be approved by at least 2 regulatory agencies. It should not have prior withdrawal/rejection from any other regulatory body.
- The device should fulfil at least one condition to be eligible for ECR.
- b. Expedited Class D Registration (EDR)
- Device should be approved by at least 2 regulatory agencies and should not have prior withdrawal/rejection from any other regulatory body.
- a. Expedited Class C Registration (ECR)
- (iv) Immediate Class C Registration (ICR)
[Solely for Standalone Medical Mobile Application]
Device should be approved by at least 1 regulatory agency. It should not have open field safety corrective actions (including recalls) at the time of submission, any safety issues, or prior withdrawal/rejection from any regulatory body.
Documents Required for Registration
- Prepare the submission dossier using ASEAN CSDT or IMDRF ToC format
- Provide proof of compliance with the reference market’s QMS requirements
- Notarization or legalization requirements depend on the submission route
- Abridged / Expedited submissions may include summary pre-clinical and clinical data
How OMC Medical Can Assist
- Register your medical device with Singapore HSA
- Prepare and compile the submission dossier for registration
- Identify the correct regulatory pathway based on device classification
- Keep you updated with current Singapore regulatory requirements
Registration Procedure
- Appoint a Singapore registrant for your medical device
- Determine the classification of the device
- Choose the appropriate submission pathway based on classification and prior approvals
- Prepare the submission dossier using ASEAN CSDT or IMDRF ToC format
- Submit the application electronically via MEDICS and pay the applicable fee
- Upon approval, the device will be listed in the Singapore Medical Device Register (SMDR)
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