Whats New
Guidance Documents (IVD)
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The following are the draft Guidance Documents on IVD medical device prepared by Medical Device Control Division for public comment: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The following is the draft Guidance Documents Product Grouping prepared by Medical Device Control Division for public comment: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.
Guidance Documents
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The following are the list of draft guidance documents and the presentation on the Proposed Medical Device Registration System prepared by this division.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These draft guidance documents and the presentation can be downloaded from this page.
List of Draft Guidance Documents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
Attachment Training at Radibems
3 officers had undergone an attachment training program at Radibems Putrajaya from 1st-5th March 2010 and 4 officers had undergone the same attachment program subsequently at Radibems Hospital Kuala Lumpur from 8th-12th March 2010. MDB would like to thank Radibems for facilitating the attachment training program.
Audit
MDB had done an audit session on Medical Latex (Dua) Sdn Bhd on the 24th-25th of February 2010. We would like to express our thanks for all the cooperation given during the audit process.
Walimatul Urus
MDB ingin mengucapkan Selamat Pengantin Baru kepada Puan Maizun bt. Mat Zin dan juga Puan Nur Syafura bt. Ariffin yang telah telah melangsungkan perkahwinan mereka pada 15 Februari 2010 dan 27 Februari 2010.
