Chapter 1 Malaysian MDA Administration Information Abstract

1. Administration and Abstract

Medical devices and IVDs are regulated by the Medical Device Authority (MDA). A federal statutory body under the Ministry of Health Malaysia, MDA is responsible for the registration and regulation of medical devices to ensure that the safety, effectiveness and quality of medical devices meet relevant regulatory standards. The implementation and supervision of part of the regulatory tasks of the regulatory agency entrusted the authorized qualified third-party agency CAB (Conformity Assessment Body).

2. Administrative Regulation

Medical Device Act 2012, Act 737

Medical Device Regulation 2012

ASEAN Medical Devices Directive 2015

3. Risk Level Classification of Medical Device and IVD Products 

4. Registration Basis

Malaysia can currently submit an application for registration without any national registration, but Malaysia also recognizes the following reference country registrations, thus entering the simple registration approaches:

①Australian TGA certificate

②EC certificate

③Health Canada License

④Japan Pre market Certification/Approval

⑤UK MHRA Certificate

⑥US FDA510(k)Determination

⑦US FDA De Novo Order

⑧US FDA Premarket Approval

5. Registration Language

English and Malay.

6. List of Registered Documents

7. Malaysian Conformity Assessment Body (CAB)

CAB is authorized by Malaysian MDA to conduct conformity assessment. CAB will audit product technical documentation and factory audit in accordance with the Medical Device Act 2012, which is similar to the role of a public body in the European Union. CAB will issue conformity assessment certificate and audit report after completion of the audit. Applicants can use it to submit MDA registration.

Chapter 2 Registration Flow, Cycle & Official Fee

1. Registration Flow 

2. Official Fee 

3. Official Audit Cycle

Chapter 3 FAQ

Q: How long does it take to register medical device products in Malaysia?

A: Class A devices and IVD diagnostic reagents are approved about 1 month after application is submitted, and will not be approved until MDA is approved and feedback is received, the registration cycle of Class BCD products is subject to the completeness of product documentations, compliance, CAB audit and MDA registration progress, if there is a reference country registration can enter the simple audit approach, CAB audit process will speed up, the whole process audit cycle is expected to last more than 6 months.

Q：Does it require QMS certificate for medical device registration?

A: Yes, ISO 13485 certificate is required for Class A registration, and the latest annual audit report is required for BCD registration in addition to the ISO 13485 certificate issued by IAF member organizations.

Q: Can medical device products be changed after registration?

A: MDA allows changes, as long as they fall within the scope of changes recognized by the MDA. It can be initiated by the local authorized representative to apply for changes.

Q: Do all classes need to go through CAB audit for registration in Malaysia?

A: Class A medical devices are exempted from the CAB conformity assessment process, Class A medical devices can submit their registration application directly through Medcast, and Class BCD devices still have to go through the CAB agency conformity assessment process.

Q: When can we use SV approach to simplify the audit?

A: CAB offers two medical device compliance assessment services: Simplified Validation Assessment (SV) and Full Confirmation (FC) assessment.

When a manufacturer has previously obtained medical device registration approval in at least one of the five GHTF countries (EU, USA, Japan, Australia and Canada), it is eligible for the simpler SV evaluation pathway.

Q: How long is the certificate valid?

A: 5 years.

Q: Is the certificate of registration transferable?

A: Licenses can be transferred from one authorized representative (AR) to another authorized agent. The new AR will fill out the application on the Ministry of Health's MEDCAST online portal. The required documents include the current AR return (Appendix B - MDA/GD0041), the letter of Termination, and the authorization for the new AR. The Ministry of Health charges about RM 500 (about US $115) for each medical device registration ID.