New regulations on Duties and Obligations of Establishments for Medical Devices in Malaysia
Coming into effect on the 1st of July 2020.
Duties and obligations of this regulation are categorized into 6 categories.
- Distribution records
Contents required for a distribution record, implantable medical device distribution record and the period of maintenance required.
- Records of complaint handling
Complaint handling procedures and requirements for a record of complaint handling and the holding of a complaint record.
- Mandatory problem reporting
This involves submitting the investigation report to the Authority which must be done within 30 days.
- Field corrective or preventive action
This states that establishments shall notify the Authority before any field corrective or preventive action is being done.
- Voluntary recall
This involves the voluntary recall within the time frames as follows,
Class I (High risk)
No less than 48 hours before the recall is made.
Class II (Medium risk)
No less than 3 days before the recall is made.
Class III (Low risk)
No less than 5 days before the recall is made.
- Mandatory recall
The Authority may order a recall of any medical device at any time for reasons of patient safety and public health.