Device registration in Malaysia is done by a Local Authorized Representative (LAR) for foreign device manufacturing companies without a physical presence in Malaysia. The normal device registration process includes going through a detailed conformity assessment before making a registration application submission. In October, the MDA promulgated a new Guidance Document for Class B, C, and D medical devices. Going forward, medical devices which already have approval from one of the following regulators – the FDA, TGA, EU NB, Health Canada, UK MHRA or Japan MHLW, are eligible for conformity assessment by way of verification. The benefit of conformity assessment by way of verification is a reduction of the CAB assessment time, government fees, etc.
The revision of this guidance document also includes MDA recognition of Singapore’s Health Science Authority and Thailand’s FDA approval, whereby medical devices with the following approvals are also now eligible for conformity assessment by way of verification, instead of going through the full CAB conformity assessment. This guidance document will apply to devices registered in Singapore’s Medical Device Register and devices approved in Thailand devices that are Class 2 or Class 3 with a Certificate of Notified Medical device or for a Class 4 device Certificate of Licensed Medical Device. However, devices that are registered in Singapore as Special Access Routes and devices in Thailand that are exempt from registration will not be eligible for assessment by verification in Malaysia.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.