Regulations
Since 1872, we have stood for safety and quality for the people, the environment and technology. Benefit from our wide range of services, expert support and areas of expertise especially designed for your product or company. Our experts offer tailored solutions on the basis of statutory regulations or your own specifications, as well as other relevant performance benchmarks and standards.
Medical Device Safety and Testing at a Glance
Start here. - Check the newest regulations, certificate transition dates, and common FAQs for in vitro diagnostic and medical device requirements. Are you prepared for EU, US and key market approval?
New Regulations for Medical Products
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Good Distribution Practice For Medical Devices (GDPMD)
Good Distribution Practice for Medical Devices (GDPMD) in the Malaysian market ensures the integrity, safety, and efficacy of medical devices throughout the supply chain.
Obtaining a GDPMD Certificate is a required step for your organization in getting an establishment license from the Malaysia Medical Device Authority (MDA).
GDPMD specifies the requirements for a quality management system to be established, implemented, and maintained by an establishment in carrying out activities in the medical device supply chain to comply with the Medical Device Act 2012 (Act 737) and the Medical Device Regulations 2012. A certified GDPMD certificate will be submitted through the MDA online system by the establishment.
Compliance Evaluation Process consists of the following processes:
- GDPMD Audit planning process
- GDPMD on-site audit process
- GDPMD audit report process
- GDPMD documents submission for Certifier review
- GDPMD report and certificate
As a certified Certification Body for medical devices in Malaysia, TÜV Rheinland can support your organization on Product Verification (PV) or Full Assessment of Technical Documentation (FATD) in accordance with Act 737 and complying with Medical Device Regulation 2012. A certified product will be submitted to the MDA online system for product licensing by the establishment.
Compliance Evaluation Process consists of the following processes:
- Application Documents Review Process
- Documents Completeness Check Process
- Final Compliance Evaluation Process
- Documents submission for Certifier review
- Report and Certificate
To understand T&C of GDPMD Malaysia, please refer PDF documents here.
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