Malaysia Medical Device Regulator MDA Revises Consultancy Services

By Yu Seen Ng and Evangeline Loh

The Malaysia Medical Device Authority (MDA) updated its consultancy services (August 2, 2023). Initially offered in July 2019, as in-person consultation services (quoted as RM 600 per hour), the MDA’s services have now been relaunched and explained in greater detail. We understand that this revision is to remind the industry that the MDA is available to assist.

The MDA now categorizes its consultancy as Non-Package Consultancy and Consultancy Package .

MDA timing of Consultancy Services

In discussion with MDA officials, MDA commits to the following timelines:

• Acknowledgement receipt: same day or within one day
• Consultancy details, including date of consultancy, place, officer in charge, invoice, and additional documents (if required): three working days from receipt of application
• Consultancy: Depends on officer availability and schedule, approximately one to two weeks after receiving the complete application

Specifics on Non-Package Consultancy

The request form structures the consultation: questions can be posed from one of ten categories (though x is a catch-all, other), and the topics are further divided into subtopics. As an example, the topic i registration is divided into a-d: general medical device, IVD, combination product, and other.

The discussion can be a virtual meeting or in person (a physical meeting maximum of three people per session). The consultation fee is RM 100 per hour.

Specifics on Consultancy Package

The request form structures the consultation: questions can be posed from one of 14 packages and the topics are further divided into modules, except for Package 6. The full package of medical device registration, Package 6, is an itemized list of documents that an entity would receive that would also be reviewed. Package 13, document review, includes Module 4, clinical investigation of medical device-investigational brochure.

The discussion is a physical meeting (maximum of three people per session) in the MDA office or the stakeholder’s office. The consultation fee is based on the number of modules or days, plus miscellaneous expenses: meeting space (food and beverage), travel and accommodation and meal allowance. Modules are generally 600 RM per module. Days are generally 2,400 RM per day. The charge for Package 6 is 7,200 RM.

Concluding remarks

The MDA is offering its consultancy services again. This revised service has been enhanced to further specify the types of questions with which the MDA is able to assist.

Emergo by UL is always an advocate of engaging the regulators at the appropriate time, as we believe that it ultimately improves the regulatory process.

Yu Seen Ng is Senior Program Service Specialist and Evangeline Loh is Global Manager, Regulatory Affairs at Emergo by UL.