Product Registration

"MALAYSIA"

Agency

MEDICAL DEVICE (KKM-MDA)

1. Good Distribution Practice for Medical Devices (GDPMD) -Ensure a good quality system to be maintained effectively for medical devices throughout the supply-chain

2. Medical Device Registration (MDR) / Medical Device Authority (MDA) -Medical devices require registration before they can be sold in Malaysia

The Malaysian Medical Device Authority (MDA) is in charge of enforcing medical device regulations and medical device registration.

Malaysia’s Medical Device Act has made it mandatory for all Manufacturers, Authorised Representative, Distributor and Importer to register their medical device with the MDA.

Companies that are involved in wholesaling and/or importing Medical Devices in Malaysia are required to implement a quality management system and obtain GDPMD certificate to applying for licence for their establishment. Do contact us for a competitive quote for medical device registration.