The time it takes to apply for D-class medical device registration in Singapore through the Health Sciences Authority (HSA) can vary, but typically, the process takes about 1 to 3 months from the submission of the application to the issuance of the registration certificate. The exact duration will depend on the complexity of the device, the completeness of the documentation submitted, and whether there are any requests for additional information from HSA.

Stages of the Review Process for D-Class Medical Device Registration

1. Pre-Submission Preparation

   • Duration: Time varies based on the manufacturer’s preparedness.
   • Before applying, you need to ensure all necessary documentation is in place (technical documents, clinical data, labeling, etc.). If you have an authorized representative in Singapore, they will typically help with this preparation.

2. Submission of Application

   • Duration: Typically 1 day.
   • The registration application is submitted via the MedReg system, HSA's online portal. You need to ensure that all documents are in the correct format and that the application is complete.
   • HSA will acknowledge receipt of the application after submission.

3. HSA's Initial Evaluation

   • Duration: Approximately 2-4 weeks.
   • HSA will conduct an initial review to check the completeness of the application and whether all required documents have been submitted. This review involves verifying if the documentation complies with HSA's Medical Device Regulations and applicable standards (e.g., ISO 13485, ISO 14971).

4. Technical Evaluation

   • Duration: Approximately 4-6 weeks.
   • HSA's technical evaluation is the core of the registration process. During this stage, HSA assesses:
     • The safety and performance of the device based on the submitted technical documents (including clinical data, risk management file, manufacturing processes, etc.).
     • Compliance with relevant international standards and the regulatory framework in Singapore.
     • HSA may request additional information if the application is unclear or lacks detail.

5. Issuance of Certificate

   • Duration: Typically 1-2 weeks after successful evaluation.
   • If the application passes the technical evaluation, HSA will issue the Certificate of Registration for the D-class medical device, allowing it to be marketed in Singapore.
   • You will also receive a unique registration number for the device, which must be used for all future communications with HSA.

6. Post-Approval Obligations

   • After the registration is approved, the manufacturer or authorized representative must adhere to post-market surveillance obligations, including adverse event reporting, periodic renewals (every 5 years), and maintaining the quality management system.

Possible Delays in the Process

• Request for Additional Information: If HSA finds any gaps or issues with the application, they may request further information or clarification. This can extend the overall timeline by an additional 2-4 weeks depending on how quickly the requested information is provided.
• Complexity of the Device: If the device is more complex or involves new technology, the evaluation process may take longer.

Typical Timeline Summary for D-Class Medical Device Registration in Singapore:

1. Pre-Submission (Preparation of documents): Varies (depending on manufacturer readiness).
2. Application Submission: 1 day.
3. Initial Evaluation: 2-4 weeks.
4. Technical Evaluation: 4-6 weeks.
5. Issuance of Certificate: 1-2 weeks.

Total estimated time: 1-3 months.

The timeline can vary, and it’s important to ensure that the application is complete and accurate to avoid delays.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn