EMERGO SUMMARY OF KEY POINTS:

• The Malaysian MDA has launched two databases to provide information on medical device registrations and licensed establishments
• MDA’s database for device registrations is publicly accessible, while its database for licensed establishments is intended only for Malaysia Authorized Representatives, distributors and importers.

The Malaysian Medical Device Authority (MDA) has rolled out two new databases for medical device registration information.

The first database, the Registered Medical Device Search, is accessible to the public and searchable by either device name or MDA registration number. Search results from this database may be used to confirm classifications of registered devices, Malaysia Authorized Representatives and registration expiration dates.

The second database, the Licensed Establishment Search, may only be accessed by licensed establishments such as Malaysia Authorized Representatives, distributors and importers. The Licensed Establishment Search provides more in-depth information: establishment names, license numbers and validity dates, designations, and related data.

Additional Malaysian medical device market resources from Emergo by UL:

• Malaysia MDA medical device registration consulting
• Malaysia Authorized Representative in-country representation
• Video overview: Malaysia’s medical device regulatory process
• Whitepaper: Malaysia MDA medical device registration requirements