ANNOUNCEMENT ON THE MEDICAL DEVICE REGULATION 2012
The Medical Device Regulations 2012, the subsidiary legislations under the Medical Device Act 2012 (Act 737), has been approved by the Minister of Health and has been published in the Gazette on 31st December 2012. The Regulations can be downloaded via the following link:
MEDICAL DEVICE REGULATIONS 2012
Among others, the Regulations specify requirements and procedural matters pertaining to medical device registration, conformity assessment body (CAB) registration, establishment licensing, export permit and appeal.
The Regulations will come into operation simultaneously with Act 737 on 1st July 2013. And as specified in Act 737 a transition period of two years for medical device registration and one year for establishment licensing will be given to the industry before it is fully enforced.
With the gazettement of the Regulations, those affected shall take the necessary steps and measures to ensure they comply with the regulatory requirements as specified under the medical device law.
For further inquiries, please contact us at 03-8885 0778 or email us at mdb@mdb.gov.my.
MEDICAL DEVICE REGULATIONS 2012Among others, the Regulations specify requirements and procedural matters pertaining to medical device registration, conformity assessment body (CAB) registration, establishment licensing, export permit and appeal.
With the gazettement of the Regulations, those affected shall take the necessary steps and measures to ensure they comply with the regulatory requirements as specified under the medical device law.
For further inquiries, please contact us at 03-8885 0778 or email us at mdb@mdb.gov.my.
