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Guidance Documents

The following are the list of draft guidance documents and the presentation on the Proposed Medical Device Registration System prepared by this division.

You may download these documents for your information on our proposed Medical Device Regulation.

These draft guidance documents and the presentation can be downloaded from this page.

List of Draft Guidance Documents
- Guidance on The Definition of Medical Device
- Guidance on The Classification of Medical Device
- Guidance on The Essential Principles of Safety and Performance of Medical Device
- Guidance on The Common Submission Dossier Template For Medical Device
- Regulatory Requirement on Good Distribution Practice
- The Proposed Medical Device Registration System

Resource:
i) GHTF
ii) HAS
iii) EU

Last Updated ( Tuesday, 06 March 2018 )
 
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