Recall action has been set out in Section 42 of Act 737. All establishments must inform Medical Device Authority of recall action related medical devices are made. Recall is any action taken by the establishment for the manufacture of medical devices that are affected or potentially affected the effectiveness of the safety and effectiveness of performance, after recognizing that the medical device:
- It may be hazardous to health.
- It may fail to comply with any demands made by manufacturers based on effectiveness, performance or safety.
- Failure to comply with legal requirements.
In the most cases, the establishment was voluntarily initiated the medical device recall and informed the Medical Device Authority to submit relevant information. However, the Medical Device Authority may order the establishment to recall the medical device by mandatory. This can happen if the establishment is reluctant to recall the devices associated with significant health problems or death.
When an establishment recall a medical device, it
- Contacts directly the customers who received the product from them, and takes actions to reach others who need to be notified (e.g. by issuing press releases or providing detailed instructions);
- Supplies information to help users identify the product and take actions to minimise health consequences; and
- Takes action to prevent the problem from happening again.
Medical Device Authority will oversee each recall to make sure that the actions the company takes are adequate to protect the public health.
During a medical device recall, Medical Device Authority :
- Works with the recalling firm to obtain information about the product, the problem, the recall strategy, and the steps to prevent the problem from happening again;
- Conducts audits to make sure the recall efforts are appropriate and effective;
- Makes sure the company takes necessary actions to prevent the problem from happening again.
To determining the recall, a factor to consider is the importance of the danger, if any, of the channels where the goods have been distributed, and the level at which distribution has occurred must be determined.
If the depth of a recall is to consumer or retail level and teh consumers or retail outlets cannot be identified, advertisements paid by the manufacturer (or the marketing authorisation holder) are to be inserted in the daily print media.
Every notice of recall to the public through the media must include :
- Name of product
- Registration number
- Unique identifying number, if any
- Pack size
- Model and model number
- Batch or serial number
- Expiry date (when this appears on the product)
- Other details necessary to allow absolute identification (e.g. Catalogue / part / order number as appropriate)
- Reason to recall
- Necessity to identify and quarantine the product from further sale or supply
- The method of recovery (or disposal, if appropriate) or product correction which will be use
- Contact number and personnel in-charge
The Implementation of Recall.
- The establishment / manufacturer has the prime reponsibility for implementing recall action, and for ensuring compliance with the recall procedure at its various stages.
- No recall, regardless of level, should be undertaken without consultation with the medical device authority and without agreement on the recall strategy.
- In cases of significant hazard to the users, the manufacturer's personnels may be utilised to immediately disseminate information on the recall.
- It is the establishment / manufacturer responsibility to recover product which is subject to recall, providing the provisions and any applicable regulations are observed.
- If the recall involves a local manufacturer that possesses overseas market, the establishment / manufacturer is required to notify overseas recipients of recall actions that affect them.
After the implementation of recall, the manufacturer (or the marketing authorisation holder) is to provide the Medical Device Authority with an interim and final reports on the recall. These reports establish the effectiveness of the recall and form the basis of reports to committee on product safety. Unless satisfactory reports are received, further recall action may have to be considered. The reports are to contain the following information :
- The circumstances leading to the recall
- The consequent action taken by the company
- The extent of distribution of the relevant batch in the country and overseas (if applicable)
- The result of the recall - quantity of stock returned, corrected, outstanding, etc
- Confirmation, where practicable (e.g. Hospitals, clinics) that customers have received the recall letter / notice
- The method of destruction or disposal of recalled goods
- The action peoposed to be implemented in future to prevent a recurrence of the problem.
To Notify a Recall
Recall form template can be downloaded here: Annex B- Medical Device Recall Reporting Form
Completed forms can be submitted to the Office of the Medical Device Authority at the address:
Level 6 , Prima 9 ,
Prima Avenue II , Persiaran APEC ,
email to recall_enquiry [AT] mda [DOT] gov [DOT] my