Certification Introduction

The Medical Device Authority of Malaysia (MDA) implements registration management for the import, export and marketing of medical devices. It is responsible for product registration, issuance of institutional licenses and market supervision, ensuring the safety, efficacy and quality standards of marketed medical devices. MDA adopts a risk-based classification principle, dividing medical devices into four classes: A (low risk), B (low-to-medium risk), C (medium-to-high risk), and D (high risk), with stricter review requirements for higher-risk products.

Laws and Regulations

Malaysian medical device regulatory basis: Medical Device Act 2012 (Act 737); Medical Device (Registration) Regulations 2012, Medical Device (Conformity Assessment) Regulations 2012. All medical devices imported, sold or placed on the Malaysian market must complete MDA registration, and cannot be marketed or distributed without registration. The regulatory mutual recognition arrangements between Malaysia's MDA (Medical Device Authority) and Singapore's HSA (Health Sciences Authority) (implemented in March 2026) and between MDA and Thailand's TFDA (Food and Drug Administration) (implemented in May 2026) have been officially put into effect. After Chinese medical device manufacturers obtain MDA registration, they are expected to enter the two core markets of Singapore and Thailand more conveniently through the regional mutual recognition framework.

Technical Requirements

The quality management system must comply with the requirements of ISO 13485 standard. Since September 16, 2025, MDA has officially become an affiliate member of MDSAP, and accepts MDSAP reports and certificates as proof of quality management system compliance. Technical documents shall be organized in ASEAN CSDT (ASEAN Common Submission Dossier Template) format, including product description, design and development information, safety performance test data, risk analysis report, verification and validation materials, labels and instructions for use that meet local requirements, etc. Malaysia recognizes 8 overseas regulatory authorities (Japan MHLW, Canada HC, Australia TGA, US FDA, EU CE, Singapore HSA, UK MHRA and Thailand TFDA). If a Chinese manufacturer of Class B, C, D medical devices has obtained regular marketing approval from any of these 8 authorities, it does not need to complete the full set of compliance approval repeatedly, and can directly submit the registration application through the Verification Pathway designated by MDA, which greatly shortens the approval time.

Certification Process

Appointment of Authorized Representative: A local Authorized Representative (AR) in Malaysia must be appointed to be responsible for submitting the registration application. The Authorized Representative must hold an Establishment Licence (institutional license) and GDPMD (Good Distribution Practice for Medical Devices) certification;

Determine risk classification and product grouping of medical devices;

Prepare technical documents using CSDT general template;

Submit application: Class A: Submit the registration application directly to MDA, no need to go through CAB (Conformity Assessment Body); Class B, C, D: Must go through the two-step process of "CAB conformity assessment + MDA registration audit";

Pay application fee → MDA review → Pay fee and obtain certificate.

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