FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

Malaysia Will Enforce Device Registration Requirements on Jan. 1

Aug. 22, 2017
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Malaysia’s Medical Devices Authority said it will fully enforce new medical device registration requirements for importing, exporting, or placing medical devices on the market from Jan. 1, 2018.

From that date, only an establishment license and a device registration certificate will be acceptable as supporting documents in the procurement process, the agency said, adding that an acknowledgment of a receipt of an application for medical device registration will no longer be valid for use as a supporting document.

Establishments that have applied for registration but have yet to submit complete information should complete the application on or before Oct. 31, 2017, the agency said.

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