Government Authority 

Medical device product registration in Malaysia is overseen by the Medical Device Authority (MDA) of the Ministry of Health Malaysia (MoHM), as stipulated under the Medical Device Act 2012, which was made effective on July 1, 2013. According to the act, medical devices require registration with the MDA before being imported and placed on the market.

Medical Device Status 

In Malaysia, a medical device is any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article intended by the manufacturer to be used, alone or in combination, for human beings for the purpose of  diagnosis, prevention, monitoring, treatment or alleviation of disease or injury. 

Product Classification 

The registration process and guidelines closely follow ASEAN Medical Devices Directive (AMDD) standards. Devices are classified into four classes A, B, C and D, ranked from low to high risk categorization. Additionally, there is a fifth category for combination devices. The registration routes vary based on the classification of the device: 

Device Conformity Assessment

Applications follow a two-step process whereby the initial completeness review is conducted by an authorized, private Conformity Assessment Body (CAB). The CAB will issue a Certificate of Conformity once approved. With this, the dossier is submitted to the MDA for evaluation. CAB evaluation and consulting fees will vary depending on a device’s risk classification. Device conformity includes both administrative and technical documentation, such as Instructions for Use, product descriptions and proper labeling in accordance with  Common Submission Dossier Template (CSDT) application requirements. 

In July 2020, Malaysia released the Medical Device (Duties and Obligations of Establishment) Regulations 2019, implementing guidelines for Adverse Event (AE) Reporting within the current mandatory registration system. The regulation states the Malaysia Authorized Holder (MAH) listed on a product’s registration certificate is responsible for all post-market vigilance communications with the Ministry of Health. 

Quality Systems Conformity Assessment 

Quality systems conformity assessment must be documented with ISO 13485 or an audit report from the FDA (e.g., Establishment Inspection Report) or Japanese PMDA.

Regulatory Efficiency

Medical device product registration in Malaysia is fairly efficient. 

Exceptions to Home Country Approval Requirement 

Recent guidance has provided for registration exemption for Class A devices (non measuring, non sterile) and a fast track provisional registration process for all other devices that have reference country approval. The fast-track route effectively extends the grace period for full registration for another 5 years.

Validity and Renewal 

The application requires a Certificate of Conformity from a local, authorized conformity assessment body (CAB).  Under the fast track system, devices with reference country approval have up to 5 years to submit the locally issued Certificate of Conformity and will be issued provisional registration  in the meantime.

License Holder Requirements 

Medical Device registration applications must be submitted via the on-line MEDCAST system by a licensed, local entity that also acts as license holder, or Malaysia Authorized Holder (MAH).

License Transfer

Licenses can be transferred from one Authorized Representative (AR) to another. The new AR will fill out an application on the MoH MEDCAST online portal. Required documents include the Current AR Declaration Form (Annex B – MDA/GD0041), Termination Letter, and Letter of Authorization from the new AR. The MoH charges about RM 500 (USD$ 115) per medical device registration ID.

Benefits of Independent License Holding through Asia Actual

• Sell directly to multiple regional distributors, avoiding mark-up by a national importer
• Increase transfer pricing 
• Improve leverage in distributor negotiations/responses
• Add or change distributors as required
• Keep intellectual property away from local commercial agents
• Assure expert handling of  post market vigilance and license maintenance

Contact Asia Actual for assistance to confirm the cost and time lines that apply to your medical devices.  Asia Actual also has experienced, top level consultants in Malaysia to manage the application process.