Regulatory Affairs Compliance for Medical Devices
INDEPENDENT AUTHORIZED REPRESENTATIVE IN MALAYSIA FOR MEDICAL DEVICES MANUFACTURERS WORLDWIDE
To be able to distribute medical devices legally in Malaysia, foreign medical devices manufacturer shall appoint authorized representative (AR) in Malaysia to represent the foreign manufacturer relating to any regulatory obligation under Act 737.
GOODMAN PLT. is certified with Good Distribution Practice for Medical Device (GDPMD), under the scope of provision of local authorized representative of medical devices. GOODMAN PLT. has also registered with Malaysia Medical Device Authority (MDA) as an authorized representative.
ESTABLISHMENT LICENSE APPLICATION AND MEDICAL DEVICE REGISTRATION IN MALAYSIA
We provide advise and assist manufacturers worldwide, local authorized representatives (LAR), importers and distributors of medical devices to obtain Establishment License and to register the medical devices or products with Malaysian Medical Device Authority (MDA).
REGULATORY AFFAIRS COMPLIANCE ASSISTANCE
We are committed to assist our clients to navigate confidently in the increasingly regulated world. We expertise in interpreting relevant regulatory requirements in medical device industry. We provide advise to assist our clients to comply with the requirements.