Medical Device Registration and Approval in Malaysia

General country-specific regulatory information is provided on this page for medical device registration and approval in Malaysia. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Malaysia, to expedite the preparation of your medical device or IVD registration application.


Medical Device Regulations and Classification in Malaysia

REGULATORY AUTHORITY: Medical devices are regulated by the Medical Device Authority under the Ministry of Health.

CLASSIFICATION SYSTEM: Devices are classified according to risk into Classes A, B, C, and D.

TIMEFRAME: As device registration was not mandatory in Malaysia until July 2014, it is not yet clear how long the approval process may take, but it is currently estimated to take about one year.

LICENSE VALIDITY: Licenses are valid for five years.

AUTHORIZED REPRESENTATIVE: An authorized representative is required to register medical devices in Malaysia.

Last updated on January 29 2015.

 For more information on Medical Device Registration in Malaysia, check out the following articles: Country at a glance: Malaysia and 5 Questions & Answers: Medical Device Registration in Malaysia

Other Southeast Asian Countries:

Cambodia, IndonesiaMyanmar, Philippines, Singapore, Thailand, Vietnam

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