The following are the draft Guidance Documents on IVD medical device prepared by Medical Device Control Division for public comment before January 31, 2013. The guidances are based on WHO, ICH and GHTF principles. As Malaysia continues to grow as a CMO for IVDs and medical devices, these guidances are being drafted to ensure the protection of public health and safety and, to ensure that new technology is made available for use for patients in a timely manner and at the same time facilitating trade in the medical device industry.
- Essential Principles of Safety and Performance for IVD Medical Devices
- IVD Medical Device Classification System
- Conformity Assessment for IVD Medical Devices
- Common Submission Dossier Template (CSDT) of IVD Medical Device
Read the full guidance here.