The Malaysian Medical Device Authority (MDA) has officially announced the launch of the Malaysia–China Joint Evaluation Pilot Programme (Phase 2), which will run from July 1 to September 30, 2026.
Unlike the previous mutual recognition approach, Phase 2 introduces a joint evaluation model, under which the MDA and China’s National Medical Products Administration (NMPA) will conduct coordinated assessments. This important initiative aims to improve regulatory efficiency and market access through bilateral collaboration, reduce duplicated assessments, and accelerate the market entry of safe, effective, and high-quality medical devices in both countries while maintaining strict safety standards.
Original announcement:
Malaysia–China Joint Evaluation Pilot Programme (Phase 2)
01. Application Requirements
02. Application Process
The overall application process can be divided into the following five key stages:
1. Eligibility Requirements
Local manufacturers must hold a valid Establishment Licence issued by the MDA in accordance with Act 737.
2. Submission and Screening
Applicants are required to submit complete pre-market documentation through the MDA’s official channel. The MDA will conduct both pilot programme eligibility screening and document completeness screening.
Applications that are incomplete or outside the scope of the pilot programme will be returned directly. Only applications that meet the requirements can proceed to the technical evaluation stage.
3. Technical Evaluation
After passing the screening stage, the MDA will designate a Conformity Assessment Body (CAB) with the appropriate technical capabilities to conduct a comprehensive technical assessment.
The CAB will assess the product’s safety, performance, risk control, and clinical evidence in accordance with the requirements of MDA/GD/0031, Guidance on Conformity Assessment for Medical Devices, and will subsequently issue the relevant conformity assessment certificate and report.
4. Formal Registration Submission
After obtaining the CAB assessment results, the applicant must submit the formal registration application through Malaysia’s MeDC@St medical device registration system, together with the relevant technical assessment documents and supplementary materials.
5. Approval and Registration
Upon completion of the final comprehensive review, the MDA will issue a Medical Device Registration Certificate for products that meet the applicable requirements and include them in the Medical Device Authority Register (MDAR).
The registration is valid for five years.
03. Pre-Market Documentation Checklist
The submission must include the following documents. Only complete applications will be accepted for processing.
Quality Management System (QMS)
- ISO 13485
- MDSAP
- QSR (FDA 21 CFR Part 820)
- Japan MHLW Ministerial Ordinance No. 169
Medical Device Information
- Device name
- Intended purpose
- Classification
- Classification rule
- Product grouping
Common Submission Dossier Template (CSDT)
The CSDT should include:
- Executive Summary
- Essential Principles of Safety and Performance (EPSP)
- Summary of Design Verification and Validation
- Non-clinical and Software Verification Studies
- Clinical Performance Data
- Labelling and Instructions for Use (IFU)
- Promotional Materials
- Risk Analysis
- Manufacturing Process Information
Other Required Documents
- Post-Market Surveillance (PMS) documentation
- Declaration of Conformity (DoC)
A Key Window for Dual-Market Access
The pilot programme will run for only three months, making it an important window for companies seeking access to both the Malaysian and Chinese medical device markets.
Manufacturers are advised to promptly confirm whether their company qualifications and products meet the pilot programme requirements, and to prepare and complete the relevant technical documentation and quality system documents in advance.
We will continue to monitor the latest developments and detailed implementation requirements of the pilot programme and provide updated regulatory interpretations and application guidance to help companies seize this market access opportunity.
If you have any questions regarding medical device registration in Malaysia, China, or other international markets, please feel free to contact us.