With a June 30 device registration deadline fast approaching, Malaysia’s Medical Device Authority has released more guidance for manufacturers working to list their products.
Malaysia is in the process of implementing its first comprehensive medical device regulations, which require registration of all devices distributed in the country (). Fast track registration is available through June 30 for devices that already have been approved for marketing in the U.S., EU, Canada, Japan or Australia. Devices that have been registered in other countries may be eligible if they meet additional conditions, as may sterile Class A devices with measuring functions.
Once products are registered, manufacturers have until July 1, 2020 to obtain a conformity assessment. However, firms must appoint a conformity assessment body to conduct the review by July 1, 2018.
The MDA may revoke registration if a device is reported to be unsafe or the manufacturer doesn’t pursue a conformity assessment. Registrations may also be put on hold if safety events requiring corrective action occur during the registration process.