A Medical Device Recall Guidance Document (MDA/GD/0015) was released by the Medical Device Authority (MDA) in Malaysia on 6th July 2020 however it officially came into operation on 1st July 2020 as stated in the P.U. (A) 318 released by the federal government. Previously, medical device recall was addressed in the legislation, P.U. (A) 318, The Medical Device (Duties and Obligations of Establishments) Regulations 2019.
Recall is any action taken an establishment, whether it be a Manufacturer, Authorized Representative (AR), Importer or Distributor of the medical device, to remove the medical device from the market or to retrieve the medical device from any person to whom it has been supplied. It also covers notifying the affected person or persons of its defectiveness or potential defectiveness, after becoming aware that the device:
- may be hazardous to health;
- may fail to conform to any claim made by the manufacturer or Authorised Representative relating to its effectiveness, benefits, performance characteristics or safety; or
- may not meet the requirements of the law.
The MDA has the right to order a medical device recall if a medical device possesses a high public health risk in the market. The Authority will monitor the whole recall process. The MDA may also take a role in communicating with stakeholders as necessary. The establishment shall put into place a documented procedure on recall to describe the actions to be taken in initiating and carrying out the recall process in a timely and effective manner to meet the requirements. The recall process is carried out in two phases:
Phase 1) Preparation and Phase 2) Implementation.
A recall may be initiated when there is problem associated with the medical device that may pose a hazard or potential risk to the user(s) or the public, which has been identified through post market information (incident or problem) received from customers. The establishment shall assess the hazard or potential risk presented by the problem associated with the medical device and classify the recall in accordance with Regulation 7 of Medical Device (Duties and obligation of establishments) Regulations 2019. The establishment shall prepare and document a recall strategy, and notify the MDA and the affected person(s), using the form in Annex B attached in MDA/GD/0015.
The establishment shall verify that all affected persons have received the recall notification and have taken appropriate action to recall the medical device. All recalled medical devices shall be identified and isolated accordingly so that that they will not be put back on the market unless rectification has been completed on the said device. The establishment shall collect the recalled medical device, quarantine the medical device and ultimately eliminate the recalled medical device from the market.
The establishment shall submit a recall report within 30 days of the completion of a recall. Recall records maintained with respect to a medical device shall be retained for a period of 5 years on top of the projected useful life of the medical device as determined by the manufacturer.
Click here to read the guidance document on the medical device recall in Malaysia. The guidance document contains a very informative process flow for medical device recall as well as templates for recall reporting, notifying end users and acknowledging responses.
If you have any queries regarding medical device recall for medical devices or our services for medical device registration and representation in Malaysia, please contact us at firstname.lastname@example.org.