Malaysian Medical Device (Duties and Obligations of Establishments) Regulations 2019

2020-02-03T01:27:30+08:00 January 28th, 2020|Insight, Medical Regulation Updates, News & Events|

The Malaysian Ministry of Health has recently released a regulation on the Duties and Obligations of Establishments of medical devices. The regulations will come into effect on the 1st July 2020.


The categories of the duties and obligations that are imposed in this regulation are as follows:

1. Distribution records
This section highlights the contents required for a distribution record, the contents required for an implantable medical device distribution record and the period of maintenance required for a distribution record.

2. Records of complaint handling
This section focuses on complaint handling procedures and highlights the requirements for a record of complaint handling and the holding of a complaint record.

3. Mandatory problem reporting
The regulation states than an establishment must submit an investigation report to the Authority within thirty days from the date of the submission of the mandatory report. For incidents that occur outside of Malaysia, if it has been reported by the establishment to the regulatory agency of the country in which the incident occurred and a field corrective action has already been taken by the manufacturer or establishment, the requirement to submit a mandatory report does not apply.

4. Field corrective or preventive action
Establishments shall notify the Authority before undertaking field corrective or preventive action. After the field corrective action or preventive action has been completed, the establishment is required to submit a report to the Authority.

5. Voluntary recall
Before an establishment undertakes a voluntary recall of a medical device, the establishment shall notify the Authority and all those affected by the recall of the medical device within the time frames outlined below:
– for a Class I (high risk) recall, no less than forty-eight hours before the recall is made;
– for a Class II (medium risk), no less than three days before the recall is made;
– for a Class III (low risk), no less than five days before the recall is made.

6. Mandatory recall
The Authority may, in writing, order an establishment to recall any medical device at any time for reasons of patient safety and public health. If the Authority is satisfied with the report of the recall (required by the establishment to undertake), the Authority may close the matter and notify the establishment in writing of its decision.