Home About Qualtech NEWS MALAYSIA: 3rd Edition of Guidance Document for Requirements for Labelling of Registered Medical Device - December 2018
MALAYSIA: 3rd Edition of Guidance Document for Requirements for Labelling of Registered Medical Device - December 2018

December 11, 2018

The second revised guidance document released in November by MDA is the 3rd revised edition for requirements for labelling of registered medical device. In this 3rd edition, there have some additions and removals of clauses which need to be take note of, as well, to avoid misunderstandings compared to the previous editions.

Some of the note-worthy changes specified in this edition have been listed below:

i)   It has been mentioned that the use of internationally recognised symbols is encouraged provided that medical device safety is not compromised by a lack of understanding on the part of the patient or user. In cases where the meaning of the symbol is not obvious to the medical device user, e.g. for a home-used medical device or for a newly introduced symbol, an explanation shall be provided.

 

ii) There has been a major modification on the requirement to include certain important information on the device label.

 

a.  Hereafter, it is compulsory to include an indication of either the batch code/lot number (e.g. on single use disposable medical devices or reagents) or the serial number (e.g. on electrically-powered medical devices), where relevant, to allow appropriate actions to trace and recall the medical devices.

 

b.  Furthermore, an unambiguous indication of the date until when the medical device may be used safely, expressed at least as the year and month (e.g. on medical devices supplied sterile, single-use disposable medical devices or reagents), where this is relevant, should also be printed on the labels.

 

c.   Moreover, it is also the manufacturer’s responsibility to notify users, where relevant, the storage conditions and shelf life following the first opening of the primary container, together with the storage conditions and stability of working solutions.

 

iii) There are also some additional labelling requirements for export only medical devices. Medical devices, which follow conditions as below, are exempted from requirements mentioned in this guidance document:

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.

 

Reference:

3rd Edition of Guidance Document for Requirements for Labelling of Registered Medical Device

 
Home About Qualtech NEWS MALAYSIA: 3rd Edition of Guidance Document for Requirements for Labelling of Registered Medical Device - December 2018