Malaysia Market Access for Medical Device Approval 

REGULATORY AGENCY

• Medical Devices Bureau (MDB), Ministry of Health

REGULATIONS

• All medical devices to be placed in Malaysian market are required to be registered under Act 737. 
• It is a mandatory requirement stated by law for establishments to obtain establishment licences to conduct activities related to medical devices. 
• The definition of medical device is in accordance with the global harmonised (GHTF). 
• Medical devices are grouped into four classes with Class A posing the lowest risk, Class B with low to moderate risk, Class C with moderate to high risk and Class D with the highest risk.

GUIDELINES

• A Local Authorised Representative (LAR) is required. 

REGISTRATION PROCEDURE

• Classify and group the medical device. 
• Submit application form through the “MeDC@St” system*. 
• Appoint a CAB to conduct conformity assessment. 
• Apply for registration. 
• Labelling of medical device.

* MeDC@St is a web-based Online Application System for Establishment Licensing, Medical Device Registration

APPLICABLE PRODUCT CATEGORIES

• The scope of this Guideline covers all medical devices to be registered under Act 737.

 △ The above picture and text are from the Internet. If there is any infringement, please contact us in time and we will delete it immediately.

As the first global market access digital platform, BWTCmall.com offers a new and unprecedented online service experience for its many users.

As a technology-driven company, BWTCmall.com is committed to developing a powerful and scalable platform that not only enables global manufacturers to quickly and accurately find the best way to reach the global market, but also to experience cost-effective cutting-edge technology and services. Let the global market access market truly enter a virtuous circle of fairness, objectivity, harmony and win-win.

Please visit the solution for get your best way of testing and certification / approvals to the target market.