New regulations on Duties and Obligations of Establishments for Medical Devices in Malaysia

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.

  1. Distribution records

Contents required for a distribution record, implantable medical device distribution record and the period of maintenance required.

  1. Records of complaint handling

Complaint handling procedures and requirements for a record of complaint handling and the holding of a complaint record.

  1. Mandatory problem reporting

This involves submitting the investigation report to the Authority which must be done within 30 days.

  1. Field corrective or preventive action

This states that establishments shall notify the Authority before any field corrective or preventive action is being done.

  1. 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.

  1. Mandatory recall

The Authority may order a recall of any medical device at any time for reasons of patient safety and public health.