December 11, 2018
In November, MDA had issued three major guidance documents, two of them being revised editions. One of these two is the 3rd revised edition of Guidance Document for Change Notification for Registered Medical Device in Malaysia.
Considering how detailed MDA has been becoming about strictly implementing the Medical Device Regulations 2012, there have been some additions and removals of change clauses affected by the regulations. Some of the important changes enforced have been noted below:
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Quality Management System |
After this, any change in scope of the QMS certification which affect the registered medical device, which is not due to safety, and/or performance of the medical device will fall under a Category 3 change also. Before the third edition’s revision, it wasn’t required to be notified to the authority. Besides, all change in manufacturing facility, process and quality management system which fall under Category 3 will require both the valid QMS certificate and latest QMS report. |
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Labelling |
Another important point to take note of is the addition of some new clauses on labelling and packaging, which do not require a change notification to be submitted. They include minor changes such as rephrasing information, change in arrangement in IFU, change of package or label colour, font size, location of information, correction of spelling mistake or any administrative change (e.g. from Rd. to road). |
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Turn Around Time |
The 3rd revised edition of this guidance document introduced turn-around-time per application for all category of changes. After this, changes in Category 3 will take approximately 15 working days while changes in Category 2 will take approximately 30 working days. This new information proves to be a great news, as manufacturer can now easily anticipate the timeline for a change notification to be approved. |
Apart from the above, it has been specified that there are some noteworthy changes in the Change Notification categories, as well.
i) Herewith, all category 3 changes may be implemented immediately without waiting for acknowledgement from the Authority upon submission of change notification application. Before this, it was compulsory to wait for acknowledgement from the Authority prior to implementing the Category 3 changes.
ii) Secondly, category 1 changes include change to the intended purpose and/or indication of use of a registered medical device, with the latest revision being unless it involves a reduction of indications for use not arising due to medical device safety or performance concerns.
Reference:
3rd Edition of Guidance Document for Change Notification for Registered Medical Device