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November 16, 2025
Approximately 5 minutes
IVD Product Registration in Malaysia: MDA Oversight, Fast Track, and ISO 13485 Mandate
IVD Product Registration in Malaysia: MDA Oversight, Fast Track, and ISO 13485 Mandate
In Vitro Diagnostic (IVD) product registration in Malaysia is overseen by the Medical Device Authority (MDA), which is part of the Ministry of Health Malaysia (MoHM). As stipulated under the Medical Device Act 2012, registration is mandatory for most IVD products before they can be imported and placed on the market.
Key Requirements and Submission
- Regulating Authority: The Medical Device Authority (MDA).
- License Holder: Applications must be submitted via the online MEDCAST system by a licensed, local entity, acting as the Malaysia Authorized Representative.
- Exemption: Class A IVD devices that are non-measuring and non-sterile are exempt from the registration requirement.
Classification and Fees
IVD device classification follows the risk-based model (A, B, C, D) defined in the Medical Device Act, with registration costs varying by class:
| Device Classification | Application Fee (MR) | Processing Fee (MR) |
|---|---|---|
| Class A | MR100 | n/a |
| Class B | MR250 | MR1,000 |
| Class C | MR500 | MR2,000 |
| Class D | MR750 | MR3,000 |
| Combination Device | MR750 | MR5,000 |
Note: Official application processing times are not yet publicly available.
Registration Pathways and Documentation
Malaysia utilizes a system of reliance on foreign approvals to expedite market access:
- Fast Track Provisional Registration: IVD devices (Class B, C, D) that have been approved in a Reference Country (e.g., US, EU, Japan) are eligible for this fast track. This allows the MDA to issue a provisional registration, effectively granting the manufacturer up to 5 years to submit the full documentation, including the locally issued Certificate of Conformity.
- Required Documentation: All submissions must include a Certificate of Conformity from a local, authorized Conformity Assessment Body (CAB).
Quality System Compliance
Quality system conformity assessment documentation is a mandatory part of the IVD registration application:
- Manufacturers must submit proof of quality compliance, typically in the form of a valid ISO 13485 certificate.
- In lieu of ISO 13485, the MDA may also accept an audit report from the US FDA (e.g., Establishment Inspection Report) or the Japanese PMDA.
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