Malaysian Medical Device Authority (MDA) Improves the Policy for Control of Medical Device Refurbishment
On June 16th 2022, the MDA announced that the policy for control of medical device refurbishment activities contained in PBPP Circular Letter Number 1 Year 2016 (Revision 2) has been improved through the issuance of MDA Circular Letter Number 3 Year 2022.
The improvements to this policy are effective as of May 9th 2022 and are as follows:
- Changes to the notification requirements for registered refurbished medical devices:
- Manufacturers who are involved in refurbishment activities are no longer needed to submit a notification to the MDA for their registered medical devices that will undergo a refurbishment process.
- Clarity of additional requirements for refurbished medical devices:
- Compliance with labelling guidelines as stated in the guidance document MDA/GD/0026 Requirements for Labelling of Medical Devices.
- The word “Refurbished” must be shown and the policy insists on a different catalog number indicated with [R].
For details of the announcement, please click here.
With the effective date of MDA Circular Letter Number 3 Year 2022, PBPP Circular Letter Number 1 Year 2016 (Revision 2) is revoked. The benefits of the revocation of PBPP Circular Letter Number 1 Year 2016 (Revision 2), is that establishments who are involved in refurbishment medical device activities could save time and resources by no longer having to prepare documents for Notification submission to the MDA.
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 firstname.lastname@example.org or click the button below