EMERGO SUMMARY OF KEY POINTS:

• Malaysian regulators will begin enforcing new combination product registration rules in July 2018.
• Combination products will have to meet requirements of both the Medical Device Authority (MDA) and the National Pharmaceutical Regulatory Agency (NPRA).
• Combination products already on the Malaysian market will have to meet new requirements when they renew their registrations.

Malaysian medical device and drug market regulators have established a July 2018 implementation and enforcement deadline for combination product registrations marketed in the country.

According to a circular letter from the Malaysian Medical Device Authority (MDA), manufacturers of combination device-drug and drug-device products will have to meet registration requirements established by the MDA and by the Malaysian National Pharmaceutical Regulatory Agency (NPRA). Specifically, Malaysian regulators have set implementation and enforcement timeframes for their recently published guidelines for combination product registration.

How Malaysia will regulate combination products

In its Guideline, the Malaysian Ministry of Health explains that a combination’s primary mode of action—via drug or medical device—determines whether that product falls under MDA or NPRA regulatory oversight.

In cases where the NPRA is the primary regulator, a combination product must first obtain certification from a Conformity Assessment Body (CAB), then endorsement from the MDA, and finally apply for registration with the NPRA before commercialization. (Combination products whose medical device components are considered Class A do not have to obtain CAB certification.)

For combination products whose primary regulator is the MDA, obtaining an NPRA endorsement is the first step, followed by CAB certification and finally MDA registration. (Again, products whose device components are classified as Class A do not have to meet CAB certification requirements.)

Implementation and enforcement deadlines

Malaysian regulators have set the following registration deadlines for compliance with combination product registration requirements:

• Any unregistered combination product must apply for registration by July 1, 2018.
• Any unregistered combination product whose registration application is submitted for evaluation before the July 2018 deadline must meet guideline requirements for registration renewal.
• Any unregistered combination product already commercialized in Malaysia before the July 2018 deadline must meet guideline requirements when renewing their registrations.

Emergo services and resources for the Malaysian market:

• Malaysian MDA registration support for medical device companies
• Malaysian medical device regulatory process chart
• Whitepaper: MDA medical device registration