February 09, 2018
On February 6, 2018, Medical Device Authority (MDA) of Malaysia released a Second Edition of the Guidance Document on Requirements for Labelling of Medical Devices. This GD serves a great purpose in informing the stakeholders on the additional requirements and content to be included in medical device labelling which are to be placed in Malaysia market or be exported.
The differences noticed in this Second Edition are as following:
1) In the General Requirements for Labelling section, it is noted that for a registered medical device, in addition to bearing the label of Malaysian medical device registration number, this label affixation shall be carried out within 6 months from the date of registration of the medical device.
2) In subsection 4.2, it is stated that Instructions for Use (IFU) may not be needed or may be abbreviated for medical devices of low or moderate risk if they can be used safely and as intended by the manufacturer without any such instructions.
3) In addition to the labels containing details of medical device to enable user to identify it, which include name; model; lot/ batch or serial number; from now on they can either print the date of manufacturing or date of expiry or the projected useful life of medical device as determined by the manufacturer (which ever is applicable to the medical devices), as well.
4) The labels must contain name and contact details (address and/ or phone number and/ or fax number and/ or website address) of the manufacturer and Authorised Representative (for foreign manufacturers) to obtain technical assistance.
5) MDA has introduced a new subsection, indicating labelling requirements for export only medical device. In this subsection, medical devices for export only, as according to Circular letter No 1, Year 2017 Rev 1, are exempted from labelling requirements Clause 4 with conditions as follows :
a) Comply with the labelling requirements of the country for export;
b) Labelled as ‘export only’ on the parcel; and
c) The medical device is not intended to be placed in Malaysian market.
For more information about the latest revisions on the Requirements for Labelling of Medical Devices in Malaysia, pls consult the Guidance Document found on MDA's database.
Guidance Document for Requirements for Labelling of Medical Devices (2nd Ed.)