In June 2022, the MDA published the first edition guideline documents on assisting the establishment of the re-registration of registered medical devices. Two stages shall be complied with by the establishment as below:

 Stage 1: Application conformity assessment to Conformity Assessment Bodies (CAB).

The CAB application is applicable for Class B, C and D only. Class A is exempted from this stage. All applications shall apply via MeDC@St. Prior to re-registering, the registration holder must apply for conformity assessment using the elements specified in the Third Schedule of MDR 2012 as follows: CAB will also review all change notifications documents approved by MDA previously:

1. Conformity assessment of the quality management system (QMS);
2. Conformity assessment of the post market surveillance system;
3. Conformity assessment of the technical documentation;
4. Conformity assessment of the declaration of conformity (DoC).

Stage 2: Application for re-registration of medical devices via MeDC@St.

1. All the applications shall be submitted through the MeDC@St application system.
2. The registration button on the MeDC@St appears within one year before the expiry date. The re-registration button appears on the completed application.
3. No changes are allowed during the re-registration process unless the change notification application is approved by MDA. Furthermore, any changes must be submitted or notified to the MDA and must be approved before submitting a re-registration application. Otherwise, the re-registration application will be returned or rejected by MDA.

Figure 1 in the new Guideline Re-registration of Registered Medical Devices (MD/GL/08) describes the Re-registration Requirement and Process Flow. The table below shows the application fees for the Medical Device Registration.

Medical Device	Fee Payable (RM)
Class A	100
Class B	250
Class C	500
Class D	750

The application and registration fees are generally the same as a new initial registration. While the timeline for Class A products is 30 working days, the turnaround time for Class B, C, and D products amounts to 60 working days.

 

 

References:
Guideline for Re-Registration of Registered Medical Devices