Conclusion to the consultation on Medical Devices Product Classification Guide

1.The Health Sciences Authority (HSA) has concluded the stakeholders’ consultation on the Medical Devices Product Classification Guide on 15 April 2021.

2. This document is intended to assist our stakeholders in determining whether a product is classified as a medical device in Singapore.

3. In summary, the feedback received were supportive of the proposed product classification guide. Majority of the feedback received were to include additional clarifications on certain product types and editorial comments.

4. HSA would like to thank our stakeholders for your feedback on the Medical Devices Product Classification Guide. The feedback received has helped to refine the Medical Devices Product Classification Guide. You may access the finalised Medical Devices Product Classification Guide here [PDF, 2148 KB].

HEALTH PRODUCTS REGULATION GROUP
HEALTH SCIENCES AUTHORITY
NOVEMBER 2021

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