MDA has recently released a revised guideline on how to apply for medical device registration under Medical Device Act 2012 (Act 737). In this revision, there are two new clause additions to take note of:
(1)“If any additional information requested by the Authority is not given by the applicant within 90 days or any other extension period granted by the Authority, the application is deemed to be withdrawn, and will be dropped from MeDC@St. However, this shall not affect the rights of the applicant to make a fresh application.”
- MDA has specified that all application are given a stop-clock time of up until 90 days or any other custom extension period granted by the Authority. Post this period, if the applicant hasn’t answered the authority’s request for additional information, the application will be dropped from MeDC@St, non-refundable, and a new application may have to be made.
(2) The application may be refused if the Authority is dissatisfied with the additional information, particulars or document given by the applicant which include:
i) Does not meet registration requirement
ii) The product is not a medical device.
* The product does not fit into the definition of medical device according to Section 2 of Act 737.
iii) Wrong classification of medical device
* The device is classified not in accordance with the rules of classification as specified in the First Schedule of Medical Device Regulations 2012.
- With effect immediately, any application which is submitted with the above shortcomings will be rejected by MDA on the MeDC@St system, non-refundable.
With these two important additions to the medical device registration guideline in Malaysia, it has gotten stricter to make an application on MeDC@St. All applications must be reviewed carefully for the device definition, classification and such before submitting online. Before this, MDA had been forgiving about the stop-clock-time exceeding 90 clock days, however after this, this guideline must be strictly adhered to, in order to avoid the application from being rejected.
Guideline on How to Apply for Medical Device Registration Under Medical Device Act 2012 (Act 737) - 3rd Edition