Further to the recent Guidance Document for Mandatory Problem Reporting, the Medical Device Authority (MDA) in Malaysia issued another guidance document on 23 June 2020 on Complaint Handling. This new guidance comes into operation on 1 July 2020 as stated in the P.U. (A) 318 released by the federal government. Previously, complaint handling was addressed in The Medical Device (Duties and Obligations of Establishments) Regulations 2019.
Complaints on any medical device can come from users of medical device such as patients, home users, healthcare practitioners, maintenance providers, or the general public. In the newly released guidance document, MDA/GD/0011, Complaint Handling, it states that establishments placing medical devices in the market, whether it be a Manufacturer or their Authorized Representative (AR), an Importer or Distributor, shall have in place a system to handle complaints received. The establishment shall appoint dedicated personnel to handle all complaints.
The elements of the complaints handling system shall include the following:
a) Receiving and recording of complaints. All complaints received shall be recorded and tracked.
b) Assessing the complaint. The criteria to determine whether the complaint is a reportable event shall be established which is based on the nature of the complaint, including but not limited to the following:
- whether there is a health hazard associated with the medical device;
- whether the medical device fails to conform to any claim made by the manufacturer relating to its safety, quality, and performance characteristics;
- whether the medical device fails to meet any legislative requirements; and
- failure of device, labelling or packaging to achieve the intended purpose of the device;
If the complaint is a reportable event,
- The complaint shall be communicated to the AR or manufacturer if the complaint was received by the distributor or importer; and
- a report shall be made by the AR or manufacturer to the Authority within the specified time (Refer to MDA/GD/0014 on Mandatory Problem Reporting).
c) Investigating the complaint. An investigation to determine the root cause of the complaint is carried out when necessary. If investigation is not required, justification shall be prepared and recorded.
d) Implementing corrective and preventive action (CAPA). The need to implement CAPA is determined by the root cause of the complaint that has been concluded in the investigation. If CAPA is not required, justification shall be prepared and recorded. If Field Corrective Action (FCA) is required as CAPA for the complaint, please refer to MDA/GD/0013 on Field Corrective Action.
e) Communicating with the complainant. The establishment may communicate with the complainant on the outcome of the investigation or the action taken to overcome the problem.
f) Recording complaints. All records pertaining to complaint, investigation, justifications and communication to the complainant, the Authority and relevant parties shall be recorded (refer 3.1.1).
g) Closing the complaint. A complaint may be closed as a result of the following:
- Invalid complaint; or
- All necessary actions have been carried out and problem(s) resolved.
Complaint 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 (for example, if the projected useful life of the medical device is one year, the complaint records should be kept for six years).
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