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Latest License Terms For Renewal Establishment License By The MDA

On 13 December 2022, the Medical Device Authority of Malaysia (MDA) has published an announcement to emphasize the requirement for applying renewal of establishment license. The establishments (local manufacturer, authorized representative, distributor, and importer in Malaysia) shall apply for renewal of its establishment license at least 90 days before the expiry date of the licence, to the Authority.

With this announcement, the establishments must comply with the regulatory requirements as specified in the License Conditions- Attachment 1. The highlighted points are as follows:

  1. The licensee must submit all information within the prescribed period when requested by the MDA.
  2. The Medical Devices Authority reserves the right to visit or inspect the licensee at any time without prior notice.
  3. Establishment Licenses issued by the Medical Devices Authority are non-transferable.
  4. The Establishment License must be displayed in a conspicuous place and must be presented if requested by any authorized officer.
  5. The license holder must apply for license renewal no later than 90 days before the license expires.
  6. The licensee may not import, export and place on the market medical devices that are not authorized by the manufacturer or Authorized Representative.
  7. The validity period of the license certificate is subject to the validity period and conditions of the Quality Management System certificate issued by the Compliance Assessment Body.
  8. The licensee shall carry out post-market responsibilities on medical devices exported, imported and/or placed on the market, even if:
    1. An Authorized Representative who is terminated by the manufacturer or terminates his business after placing the Medical Device on the market, until the end of the medical device’s useful life.
    2. A local manufacturer that has ended its business after placing a medical device on the market, until the end of the medical device’s useful life.
  9. The Establishment License will be suspended or canceled if the Licensee is found to have committed an offense in violation of the act, rules and conditions of the license as stated in Section 22, Act 737.10. 
  10. An Establishment License issued physically or virtually is Medical Device Authority Proprietary Rights. The Authority reserves the right to obtain this License when the Establishment License is revoked.
  11. In the event of loss or damage of the Establishment License Certificate, the Authority must be notified, and each license replacement will incur a service charge.

Any establishment renewal applications made beyond the license expiry date will not be accepted. All refund claims for application fees and license renewal fees will not be accepted for license renewal applications that have been made beyond the license expiry date.

More information regarding the License Conditions can be accessed here (in Malaysian language)

The MDA Announcement can be accessed here https://www.mda.gov.my/announcement/1093-syarat-syarat-lesen-terkini.html

Further information of the Establishment License Renewal process can be found in MDA guidance No. MDA/GD/0027 2nd Edition https://portal.mda.gov.my/documents/guidance-documents/2217-guidance-document-licensing-for-establishment-second-edition/file.html

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