A. Guidance Documents on In Vitro Diagnostic (IVD) Medical Device

The following are the draft Guidance Documents on IVD medical device prepared by Medical Device Control Division for public comment:

1. Essential Principles of Safety and Performance for IVD Medical Devices

2. IVD Medical Device Classification System
3. Conformity Assessment for IVD Medical Devices

4. Common Submission Dossier Template (CSDT) of IVD Medical Device

You are welcome to give comment and feedback on the draft documents. Please list all your comment in the Comment Form and submit it to mdb@mdb.gov.my before 31 January 2012.

Resource:
i. Global Harmonization Task Force (GHTF)
ii. ASEAN Consultative Committee for Standards and Quality - Product Working Group on Medical Device( ACCSQ – MDPWG)


B. Guidance Document on Product Grouping

The following is the draft Guidance Documents Product Grouping prepared by Medical Device Control Division for public comment:

1. Product Grouping

You are welcome to give comment and feedback on the draft document. Please list all your comment in the Comment Form and submit it to mdb@mdb.gov.my before 31 January 2012.