In Malaysia, the registration of medical devices is the responsibility of the Medical Device Authority (MDA) under the Ministry of Health of Malaysia. The main local regulations including the Medical Device Act 2012, etc. Since Malaysia is an ASEAN member state, it will also refer to relevant ASEAN regulations.

MDA classifies medical devices into class A, B, C, and D according to risk levels from low to high. For the registration of low-risk Class A devices, manufacturer can submit application directly to the authority; while higher-risk Class B, C, and D products require a conformity assessment by a third-party agency CAB (Conformity Assessment Body) before submitting a registration application. CAB will issue certificates to manufacturers only after reviewing the technical documents and quality management system (QMS). The Malaysian authorities’ requirements for technical documents can be referred to the ASEAN Common Submission Dossier Template (CSDT). It should be noted that even though the registration of class A product does not require audit of the manufacturer’s QMS, the manufacturer still needs to comply with ISO 13485.

The "reference countries" recognized by Malaysia include Australia, Japan, Canada, the United States, and the European Union. If the product has been registered in one of the above mentioned regions, the registration process in Malaysia can be accelerated. If the product has not been registered in the above mentioned regions, register in the country of origin will be required before entering the Malaysian market.

Depending on the product classification, the registration time ranges from a few weeks for low-risk products, to about 10 months for high-risk products. Registration fees for the authority and the fees for the third party CAB also range from tens to around one thousand dollars. The registration certificate is valid for five years.

Osmunda’s global team can assist you in completing product registration in Malaysia and provide you with local agency services in Malaysia. If you want to know more about the registration of your product in Malaysia, please feel free to contact us.