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Singapore HSA

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Singapore HSA

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:
Full Evaluation Route
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.
Abridged Evaluation Route
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.
Immediate Registration Evaluation Route (IBR)
This route ensures immediate registration upon submission. Devices should fulfil mentioned conditions to be eligible for this route.
Expedited Registration Route (ECR)
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: For class B there are 3 routes for registration.

(i) Full Evaluation Route

(ii) Abridged Evaluation Route (device should be approved by at least 1 regulatory agency)

(iii) Immediate Class B Registration (IBR) Evaluation Route

Conditions to apply for this route are:

Condition 1: Device should be approved by at least 1 regulatory agency & marketed 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 at least fulfil one condition to be eligible for IBR.

Class C and Class D: For class C and class D there are 4 routes for registration.

(i) Full Evaluation Route

(ii) Abridged Evaluation Route (device should be approved by at least 1 regulatory agency)

(iii) Expedited Evaluation Route

a. Expedited Class C Registration (ECR)

Conditions to apply for this route are:

Condition 1: Device should be approved by at least 1 regulatory agency & marketed 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 at least fulfil one condition to be eligible for ECR.

b. Expedited Class D Registration (EDR)

Condition to apply for this route is that the device should be approved by at least 2 regulatory agencies. It should not have prior withdrawal/rejection from any other regulatory body.

(iv)  Immediate Class C Registration (ICR) Evaluation Route [solely for Standalone Medical Mobile Application]

Condition to apply for this route is that the device should be approved by at least 1 regulatory agency. It should not have open field safety corrective actions (including recalls) at the point of submission, any safety issue & no prior withdrawal/rejection from any other regulatory body.

Documents required for registration (notarization or legalization required or not?):

  • Prepare Submission Dossier using ASEAN Common Submission Dossier Template (CSDT) format or IMDRF Table of Contents (ToC) format.
  • Provide proof of compliance with the reference market’s QMS requirements
  • Abridged/Expedited submission: Summary data can be submitted for pre-clinical and clinical data.

How OMC Medical can assist you with the process

  • Register your device with HAS
  • Assist you in preparing submission dossier for registration
  • Keep you up to date with the Singapore regulatory requirement

Registration procedure

  • Appoint a Singapore registrant for your device.
  • Decide the classification of the device.
  • Choose the pathway for submission depending on the classification and prior country approvals of the device.
  • Prepare Submission Dossier using ASEAN Common Submission Dossier Template (CSDT) format or IMDRF Table of Contents (ToC) format.
  • Where to register: Registrant submits application electronically via the Medical Device Information and Communication System (MEDICS).
  • Pay fee.
  • After approval device will get listed in the Singapore Medical Device Register (SMDR).

Why Choose Us

  • Working towards client satisfaction
  • Cost effective solutions
  • Project completion before deadline
  • Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk

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