Oct 29, 2019

Malaysia’s medical device market regulator, the Medical Device Authority (MDA), recently held a conference in Kuala Lumpur to discuss updates to the country’s device registration requirements.

According to Emergo by UL consultants who attended the conference, issues under consideration by MDA include re-registration requirements under the Medical Device Regulations 2012; enforcement of customs orders for import/export activities; advertising regulations; and enforcement of post-market surveillance and vigilance requirements.

Final decisions on medical device re-registration still pending

First, MDA has yet to issue a final decision regarding specific re-registration requirements for medical devices sold in Malaysia; however, the regulator does intend to enforce re-registration requirements for all market applicants (registrations are valid for five years).

Along with re-registration details, MDA may also implement changes to Malaysia’s regulatory system including:

  • Raising market application and registration fees for all device classes;
  • Exempting Class B devices (low to moderate risk) from Conformity Assessment Body (CAB) review requirements;
  • Limiting the number of devices and device components that may be included in Class A low-risk listings.

Prohibition order and advertisement issues

Second, MDA officials clarified that customs orders involving prohibition of device imports and exports will be enforced at Malaysian points of entry, and that establishments—manufacturers, distributors, importers and/or Authorized Representatives—are required to apply for electronic permits in order to legally perform import/export activities. MDA will implement a system and charge associated fees for submission of these permits.

In addition, MDA stated plans to enforce its advertising regulation whereby all device advertisements must receive approval from the agency before publication or broadcast. A related Code of Advertisement is currently being drafted, according to the regulator.

Post-market Surveillance and Vigilance (PMSV) enforcement

Third, Malaysia’s new PMSV regulation is slated to take effect on July 1, 2020. Prior to final implementation, MDA will streamline related guidance documents (planned for November 2019); push through amendments and updates to guidance documents (March 2020); and then finalize guidance (July 2020).

Learn more about Malaysian medical device regulations at Emergo by UL: