EMERGO SUMMARY OF KEY POINTS

• Malaysia plans to ratify the ASEAN Medical Device Directive (AMDD) in mid-2017.
• The Malaysian Medical Device Authority (MDA) plans to publish several new guidance documents in the near future.
• MDA plans to overhaul Malaysia’s medical device regulatory system are underway.

Malaysia’s medical device market regulatory agency has provided updates on various fronts at a recent seminar attended by Emergo consultants.

At the seminar, the Malaysian Medical Devices Agency (MDA) covered issues including ratification of the Association of Southeast Asian Nations (ASEAN) Medical Device Directive (AMDD), change notification issues for MDA registrants, and revisions to the country’s existing medical device regulations.

ASEAN Medical Device Directive in 2017?

MDA officials at the seminar stated they expect to ratify the AMDD, a framework intended to harmonize medical device regulations across 10 ASEAN member nations, in mid-2017, at which point the ratification would be published in Malaysia’s Official Gazette.

First announced in 2012 and 2013, the AMDD remains very much a work in progress, although Singaporean and Malaysian governments have made the most progress in terms of implementing the directive.

Malaysian medical device regulation updates and revisions

Malaysian regulators have also undertaken revisions to the country’s current medical device regulatory system. According to MDA officials, some existing policies such as fast-track device registration during the country’s regulatory transition period have either already been or will be withdrawn; others pertaining to labeling requirements and recognition of laboratories to conduct clinical assessments of devices remain to be finalized.

The MDA is also developing several new guidance documents for Malaysian market registrants on topics including changes of registration ownership, change notifications for devices, advertising rules, conformity assessment, device recalls and field safety corrective actions (FSCAs).

Change notification questions still outstanding

Although the MDA seminar had initially been set up to address Malaysian market registrants’ questions regarding change notification issues, regulatory representatives focused on other areas such as AMDD ratification and upcoming guidance documents. Emergo consultants in Kuala Lumpur are following up with MDA officials to clarify questions regarding change notifications.

Malaysia services and resources from Emergo

More information and support for medical device companies interested in Malaysia include:

• Malaysian MDA medical device registration consulting
• Authorized Regulatory Representation for medical device companies with no presence in Malaysia
• Whitepaper on Malaysia’s medical device registration requirements
• Malaysian regulatory video overview