Overview of Malaysia regulatory framework
Medical devices in Malaysia are regulated by the Medical Device Authority (MDA) under the Ministry of Health. The regulatory framework is based on the:
These regulations establish the medical device and IVD regulatory framework, registration requirements, and classification rules.
Medical device and IVD classification in Malaysia
Medical device classification in Malaysia is based on the Medical Device Act 2012 and Medical Device Regulations 2012, though the classification scheme aligns with ASEAN device classification rules. Devices and IVDs are classified into Class A, B, C and D by risk level (refer to MDA medical device classification guidance and IVD classification guidance).
Regulatory pathways for medical devices in Malaysia
MDA has two regulatory routes for medical devices and IVDs: full conformity assessment and verification. The verification route is an expedited review pathway that requires prior authorization in one of MDA’s approved reference markets.
Full conformity assessment
For class B, C, and D devices, a Conformity Assessment must first be carried out by the Conformity Assessment Body (CAB) in Malaysia (Class A devices are exempt from this requirement), similar to a review by an EU notified body. Once the conformity assessment has been completed and the CAB has issued a certificate and audit report, the application for registration can be submitted to MDA for review. Your dossier must be in Common Submission Dossier Template (CSDT) format and submitted via MeDC@St, MDA’s online portal.
Documentation requirements include:
- CSDT dossier
- Essential Principles checklist
- Declaration of Conformity
- QMS certificates & manufacturing site information (ISO 13485 certificate)
- CAB certificate and report (except Class A exempted situations)
- Pre-market approvals (if claimed)
- Device description
- Intended use statement
- GMDN code
- Labeling
- Risk management documents
- Validation reports (if applicable)
- Post-market history disclosures
- Grouping list
- Manufacturer details
On approval, MDA will issue a registration certificate that must be renewed every five years.
Class A devices are exempt from CAB review and will submit all documentation directly to MeDC@St. Additional validation documentation is required for Class A measuring and sterile devices.
Verification pathway
Malaysia’s medical device verification route is an expedited review pathway for devices with current authorization from one of the MDA’s recognized regulatory authorities:
- EU Notified Bodies (MDR or legacy directives)
- US FDA
- TGA (Australia)
- Health Canada
- MHLW (Japan)
- MHRA (UK)
- HSA (Singapore)
- Thai FDA
The steps in the verification pathway are similar to the full conformity assessment route. CAB review and CSDT dossier formatting are still required. However, reference market review is faster. Verification review focuses on QMS compliance, postmarket surveillance, technical documentation, and Declaration of Conformity.
Documentation requirements for the verification pathway include:
- Regulatory approval evidence (certificates from your reference market)
- QMS certificates & manufacturing site information (ISO 13485 certification, MDSAP, FDA QSR/QMSR, or Japan MHLW Ordinance 169)
- PMS history (last three (3) years) & attestation
- Complete CSDT technical documentation
- Preclinical studies, clinical evidence/CER
- Labelling
- Risk management report
- Manufacturing process file
- Declaration of Conformity
Quality Management System Requirements under MDA
Every medical device manufacturer marketing devices in Malaysia must maintain a certified quality management system (QMS). MDA recognizes ISO 13485 as the primary standard, but it also accepts MDSAP, US FDA QSR, or Japan’s MHLW Ordinance 169 under the verification pathway.
Establishment licenses for medical device manufacturers
Manufacturers, importers, distributors, and Authorized Representatives based in Malaysia must hold an Establishment license from the MDA. Under the Single License policy, multiple roles cannot be combined under a single license. For example, an AR acting as a representative must obtain a separate license for each function.
Manufacturers based outside Malaysia do not need a license for their company but must retain a Malaysia-based AR who holds a valid establishment license.
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