Post Market Surveillance of Medical Devices in Malaysia

The Medical Devices (Duties and Obligations of Establishment) Regulations 2019 detail the requirements for post market surveillance and vigilance for all medical devices in Malaysia as legislated for in Chapter 3 of the Medical Devices Act 2012 (Act 737). These regulations are imposed to ensure manufacturers, importers, distributors and local authorized representatives carry out their responsibilities to monitor and continuously ensure the safety and performance of medical devices that are placed in the market. As a member country of ASEAN, these regulations uphold the ASEAN Medical Device Directive (AMDD) which came into effect on 1^st January 2015. Please read on to understand how post market surveillance is implemented in Malaysia.

In Malaysia, post market surveillance is separated into 4 different categories:

Mandatory Problem Reporting

Mandatory problem reporting, referred as to Adverse Event (AE) reporting in the ASEAN Medical Device Directive (AMDD), is a post marketing risk assessment measure to ensure the continued safe use of medical devices as part of a post market surveillance system. This includes:

submitting a mandatory problem report to the Malaysian Medical Device Authority (MDA) when an incident relating to a medical device occurs inside or outside Malaysia if the medical device is registered in Malaysia* (see below),
carrying out an investigation to determine the root cause of incident and,
carrying out Corrective and Preventive Actions (CAPA) to eliminate or reduce the risk of recurrence of the incident.

The MDA will evaluate the investigation report and if the report and action taken are satisfactory, the MDA will inform the establishment in writing to close the matter.

*The requirement to submit a mandatory report does not apply to any incident that occurs outside Malaysia if that incident has been reported by the establishment to the regulatory agency of the country in which the incident occurred and a field corrective action has been undertaken by the manufacturer or establishment in the country where the incident occurred and on all the affected devices placed in the Malaysian market as specified by Regulation 5(7) of Medical Device (Duties and Obligations of Establishments) Regulations 2019.

Complaint Handling

Establishments must provide a standard form for submitting complaints relating to their medical device. The establishment shall provide instructions on where to submit the complaint form. Complaints may come from users of medical device such as patients, home users, healthcare practitioners, maintenance providers, or the general public.

Field Corrective Action (FCA)

Field Corrective Actions, also referred to as Field Safety Corrective Action (FSCA) in the ASEAN Medical Device Directive (AMDD), may arise from post market surveillance information such as product complaints, incidents (such as those mentioned above in mandatory problem reporting), market surveys, research and development activities and others.

FCAs might also be required by the MDA for medical devices that are no longer in the market or have been discontinued but could possibly still be in use (e.g., implants).

Field Corrective Actions are carried out to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device. This may include:

a) medical device recall
b) device modification due to potential nonconformity, such as retrofitting, changes to the labelling or instructions for use, software upgrades, modification to the clinical management of patients.
c) medical device exchange
d) medical device destruction; and
e) specific advice given by establishment regarding the use of the medical device.

Medical Device Recall

Recall is part of a post-marketing risk assessment measure to ensure the continued safe use of medical devices and is an important part of the post-market surveillance system.

Voluntary Recall

Recall is any action taken by the establishment 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 and to notify its affected person of its defectiveness or potential defectiveness, after becoming aware that the device:

a) may be hazardous to health
b) may fail to conform to any claim made by the manufacturer/ Authorized Representative relating to its effectiveness, benefits, performance characteristics or safety or
c) may not meet the requirements of the law.

Mandatory Recall

The MDA has the right to order a medical device recall if a medical device possesses a high public health risk from the market as described in section 42 (4) of Medical Device Act 2012 (Act 737). The establishment is responsible for all recall procedures as per Clause 3. The Authority will monitor the whole recall process and may also take a role in communicating with stakeholders involved if necessary.

The Authority will assess the health hazard presented by a medical device that is being considered for a mandatory recall action. As examples, the following factors may be taken into account:

a) whether any serious illness or injury has already occurred from use of the device, and the likelihood of occurrence of the incident when the device is continued to be used
b) whether any existing conditions could contribute to a clinical situation that could expose the public to a health hazard
c) whether it gives potential hazard to individual groups within the exposed population (such as children, the elderly, patients having surgery or to those who are with special conditions, as an example: immune compromised individual), and the degree of seriousness of the health hazard to which the population will be exposed
d) whether there are serious illnesses and injuries reported that have already occurred from the use of the device, and the establishment is aware about the risk but not acting on its own initiative
e) whether alternative treatment options are available, including the risk associated with providing no treatment if an alternative is not available.

How Andaman Medical can help you with post market surveillance in Malaysia

With 6 local offices throughout Southeast Asia, Andaman Medical provides support for your post-market surveillance activities including mandatory problem reporting and FCA as part of our local authorized representative services. Our local, in-house staff liaise with the MDA to help you maintain compliance once your medical device is placed on the market. Our services include:

support your Mandatory Problem Reporting and Field Corrective Actions
identify requirements in medical device directives, standards, and guidance documents to ensure effective implementation of a post-market surveillance system
evaluate your PMS data to ensure that existing processes and outputs are fully compliant
monitor and report on any regulatory changes to ensure ongoing compliance