In Malaysia, Post-Market Surveillance and Vigilance (PMSV) is regulated under the Medical Device Act 2012 (Act 737) and Medical Device (Duties and Obligations of Establishment) Regulations 2019. Back in June 2020, MDA published five new PMSV guidance documents. All establishments registered with MDA need to establish PMS procedures to ensure that the medical devices placed in the market are safe and effective to be used by the end-user. PMSV of medical devices covers post-registration activities such as:

1. a. Distribution record maintenance,
2. b. Complaint handling,
3. c. Mandatory Problem Reporting (MPR),
4. d. Field Corrective Action (FCA) and Field Safety Notice (FSN),
5. e. Recall (both voluntary and mandatory).
6.  

The maintenance of the record must be kept by the establishment for each PMSV activities as Table 1:
Table 1: Period of Maintenance for each PMSV activities

PMS Activity	Period of Maintenance
Distribution record maintenance	a. 2 years after placed in the market, b. 2 years  from the shipped out from Malaysia, c. The projected useful life. (determined by the manufacturer).
Complaint Handling	At least 5 years and on top of the projected useful life determine by the manufacturer.
Recall	At least 5 years and on top of the projected useful life determine by the manufacturer.

1. 1. Complaint Handling

Any complaint that comes from users, in any form (written, electronic or oral communication), that alleges deficiencies related to the safety, effectiveness, and performance of the medical device that has been placed in the market, needs to be recorded by the establishment. The establishment is required to assess the complaint’s details. From there, it can be determined whether the complaint is a reportable event, if it meets the criteria as stipulated in guidance document MDA/GD/0011, Section 3.1.
An assessment must be carried out to find the root cause of the complaint. Once the establishment identifies the root issue, the necessary actions, either corrective and preventive action (CAPA), or any other further action can be considered to be taken. From the assessment, the establishment can categorize how to file the complaint, as field corrective action (FCA), field safety notice (FSN), or conduct recall of the device. MDA advises establishments that once any complaint is received, regardless of severity, it is advisable to submit the initial report as soon as possible. 

 

1. 2. Mandatory Problem Reporting

Any incident that happens inside or outside Malaysia when comes to the establishment's attention shall be submitted as a Mandatory Problem Reporting (MPR) to MDA. This is only if the medical device is registered in Malaysia. For any incidents that happen outside Malaysia, MPR is not applicable when the incidents have been reported to the regulatory country in which the incidents occur and FCA has been taken.
MDA advises all the establishment to submit an MPR, as soon as the incidents occur, even if there is not enough information yet. MDA also encourages establishments to submit incidents report that happened outside of Malaysia, even if the incident has been resolved. The MPR Guidance document, MDA/GD/0014 has included clear examples of MPR forms for establishment to use. But MDA still accepts if manufacturers use their own version, as long as all the MDA requirements are included.
MDA allows any local establishment to submit an MPR.  In a situation where the distributor is the first contact with the end-user, the distributor may submit the MPR to MDA. However, the distributor needs to inform the device’s AR as soon as possible regarding the incidents. This is because AR holds the main responsibility of reporting to MDA on behalf of a foreign manufacturer. A report submitted by the AR is the main report that MDA will check, if there is double reporting between the distributor and AR on the same product.

 

1. 3. Recall

In case of a complaint that requires the establishment to recall the device from the market, they need to notify end users within the provided timeline, following its risk. Device recall is divided into two categories, namely voluntary recall, where the establishment initiates the recall themselves, and mandatory recall, where the authority in this situation the MDA may in writing order and establishment to recall any medical device at any time due to the patient safety and public health. MDA is open for any consultation if the establishment is unsure regarding the classification of the recall risk.

1. 1. 3.1 Voluntary Recall

Table 2: Reporting timeline according to the criteria for MPR and Voluntary Recall

PMS Activity	Period of Reporting	Reporting Criteria
MPR	Within 30 days	Failure of the device or a deterioration in the effectiveness of the device that has not led to death or serious deterioration in the state of health
	Within 10 days	Incident has led to the death or serious deterioration in the state of health
	Within 48 hours	Incident is a serious threat to the public health.
Voluntary Recall
Initial Report	48 hours before the recall is made	Class I (High Risk) In situation where there is a high possibility that the defective medical device will cause serious health problems or even death
	≤3 days before the recall is made	Class II (Medium Risk) In situation where there is either a possibility that the defective medical device will cause temporary or reversible health problems, or there is a remote possibility that the defective medical device will cause serious problems.
	≤ 5 days before the recall is made	Class III (Low Risk) In situation where there is a probability that using or being exposed to the defective medical device will cause health problems.
Final Report	All class	30 days after the submission initial report

1. 1. 3.2 Mandatory Recall

For mandatory recall, the report shall be submitted within a time determined by the MDA. MDA also emphasizes that the case will be closed only if they are satisfied with the investigation report. They may request for more information, as below.

1. i. Further investigation by the manufacturer;
2. ii. Recall the medical device;
3. iii. Cancel the product registration;
4. iv. Suspend or revoke the local establishment’s licence.

 

Conclusion
Towards full compliance, MDA will implement and monitor gradually for adaptation to the new requirements. MDA hopes to strengthen the compliance by raising awareness programs to promote readiness among the establishments. The timeline for full enforcement of the above PMS requirements will be announced soon. Apart from that, MDA will also launch a pilot online reporting system which will test by the selected establishment upon invitation from MDA by end of August 2021. MDA predict they can fully enforce the new regulation as early as the 1st quarter of 2022.

 

References

1. (a) Medical Device Act 2021 (Act 737)
2. (b) Medical Device Regulations 2012
3. (c) The Medical Device (Duties and Obligations of Establishments) Regulations 2019
4. (d) MDA/GD/0012 DISTRIBUTION RECORDS
5. (e) MDA/GD/0014 MANDATORY PROBLEM REPORTING
6. (f) MDA/GD/0011 COMPLAINT HANDLING
7. (g) MDA/GD/0013 FIELD CORRECTIVE ACTION (FCA)
8. (h) MDA/GD/0015 MEDICAL DEVICE RECALL