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…