SGS Approved as Conformity Assessment Body from Medical Device Authority
SGS (Malaysia) Sdn Bhd is pleased to announce that it is now a registered Conformity Assessment Body (CAB) under the Medical Device Authority (MDA) and able to carry out audits as per the Medical Device Regulations 2012.
The Medical Device Regulations simultaneously came into operation with the Medical Device Act 2012 (Act 737) on 1st July 2013. Also, as specified in the Medical Device Act 2012 (Act 737), the industry is granted a transition period of two years for medical device registration while one year is granted for establishment licensing before it is fully enforced by the Medical Device Authority (MDA).
The Medical Device Regulations 2012, a subsidiary legislation under the Medical Device Act 2012 (Act 737) was approved by the Ministry of Health and published in the Gazette on 31st December 2012. 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 gazetting of the Regulations, those affected should take the necessary steps to ensure compliance with the regulatory requirements as specified under the medical device law.
Our knowledge and experience in the medical devices and supply chain market make us the partner of choice for audits against the required standards.
For more information on certification, audit and training services for Medical Devices with SGS, please contact:
Systems and Services Certification
SGS (Malaysia) Sdn Bhd
Unit 10-1, 10th Floor
Bangunan Malaysian RE
No 17, Lorong Dungun
50490 Kuala Lumpur
t: 03-2095 9200
The SGS Group is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. With more than 75,000 employees, SGS operates a network of over 1,500 offices and laboratories around the world.