obsolete medical equipment

Malaysia’s Medical Device Authority (MDA) Amends Policy for Control over Orphaned, Obsolete and Discontinued Medical Devices

On June 16th 2022, the MDA has announced an amendment to the policy for control of orphaned, obsolete and discontinued medical devices in any facility including hospitals and health facility institutions.

 

Originally contained in PBPP Circular Letter No. 2 of 2018 (Revision 2) the amendment was passed through the issuance of MDA Circular Letter No. 2 of 2022, effective May 9th 2022.

 

The amendments of this policy are as follows:

  1. Revocation of notification requirements for orphaned, obsolete, and discontinued medical devices. Establishments / Institutions of Health Facilities no longer need to submit Notification requests to the MDA for orphaned, obsolete and discontinued medical devices.
  2. With the effective date of MDA Circular Letter Number 2 Year 2022, PBPP Circular Letter Number 2 Year 2018 (Revision 2) is revoked.
  3. Additionally, due to the revocation of the PBPP Circular Letter Number 2 Year 2018 (Revision 2), the relevant guidance including the Notification Guidance Document for Orphaned Medical Device, MDA/GD/0053 and the Notification Guidance Document for Obsolete & Discontinued Medical Device, MDA/GD/0055 are no longer applicable from the effective date of this circular letter.

Please find the original announcement here.

If you have any queries regarding the new requirement on refurbishment medical devices activities or our services for medical device registration and representation in Malaysia, please contact us at sales@andamanmed.com or click the button below.

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