Medical Device Post Market Surveillance (PMS) in Malaysia

Keeping your medical devices safe, compliant, and reliable in Malaysia’s regulatory landscape can be challenging. With Andaman Medical’s expert medical device post-market surveillance in Malaysia, we take the stress off your shoulders by managing the entire process for you. From navigating local regulations to demonstrating ongoing device performance and safety, we ensure your products remain compliant, reliable, and ready for market success.

Why Get Medical Device PMS in Malaysia?

Post-market surveillance is about more than just ticking boxes, it’s about ensuring patient safety, maintaining market access, and building trust in your brand.

At Andaman Medical, we provide comprehensive PMS solutions to help you navigate Malaysia’s regulatory landscape with ease. Leveraging our expertise in local regulations and the medical device industry, we ensure your device’s safety and compliance while proactively mitigating risks, improving product quality, and enhancing patient outcomes.

Here’s how Andaman Medical helps you solve the challenges of medical device post-market surveillance in Malaysia:

Our Medical Device Post Market Surveillance Services

Report Management

Support for your mandatory reporting of Adverse Effects and Field Safety Corrective Actions

Documentation

Identify requirements in medical device directives, standards, and guidance documents

Data Evaluation

Evaluate your PMS data to ensure that existing processes and outputs are fully compliant

Maintain Compliance

Monitor and report on any regulatory changes to ensure ongoing compliance

What You Need to Know About Medical Device PMS in Malaysia

Mandatory Problem Reporting

Mandatory problem reporting, also known as Adverse Event (AE) reporting under the ASEAN Medical Device Directive (AMDD), is a post-market risk assessment measure designed to ensure the continued safe use of medical devices in Malaysia. As part of the post-market surveillance (PMS) system, this includes:

  • Submitting a mandatory problem report to the Malaysian Medical Device Authority (MDA) when an incident involving a medical device occurs, either inside or outside Malaysia, if the device is registered in Malaysia.*
  • Conducting an investigation to determine the root cause of the incident.
  • Implementing Corrective and Preventive Actions (CAPA) to mitigate the risk of recurrence.
The MDA evaluates the investigation report and, if satisfied with the findings and actions, will inform the establishment in writing to close the case.

*Note: The requirement to submit a mandatory report does not apply to incidents outside Malaysia if the incident has already been reported to the relevant regulatory agency in that country, and appropriate field corrective actions have been undertaken on all affected devices placed on the Malaysian market, as specified by Regulation 5(7) of the Medical Device (Duties and Obligations of Establishments) Regulations 2019.  

Complaint Handling

Medical device establishments must provide a standard complaint form for users to report issues related to their devices. Complaints may come from a variety of sources, including patients, healthcare practitioners, maintenance providers, or the general public. Clear instructions should be provided on where and how to submit complaints, ensuring proper handling of all device-related issues.

Field Corrective Actions (FCA)

Field Corrective Actions (FCA), also referred to as Field Safety Corrective Actions (FSCA) under the AMDD, are initiated based on post-market surveillance information such as complaints, incidents, market surveys, or research and development activities.

FCAs are designed to reduce the risk of serious injury or death associated with medical devices. These actions can include:

  • Medical device recall
  • Device modification (e.g., retrofitting, labelling changes, software upgrades)
  • Changes to clinical management of patients
  • Device exchange or destruction
  • Providing specific advice to users on the safe use of the device.
FCAs may also be required for discontinued devices that could still be in use, such as implants.

Distribution Records

A distribution record is a detailed document maintained by medical device establishments to track the movement of devices throughout the supply chain. It plays a critical role in ensuring product traceability, safety, and regulatory compliance as part of the post-market surveillance process.

Key Information Included in Distribution Records:

  • Consignee details (name, address, contact information)
  • Device details (product name, model, batch/serial number, quantity)
  • Delivery and receipt information (dates, shipping documents, proof of delivery)
  • Disposal information (if applicable)
  • Other relevant details as required by the MDA (e.g., classification, expiry date)
Importance of Distribution Records:

  • Product Recall: Enables easy identification and retrieval of affected devices.
  • Adverse Event Reporting: Helps track devices to identify potential adverse events.
  • Regulatory Compliance: Ensures adherence to Good Distribution Practices (GDP) and other regulations.
  • Market Surveillance: Monitors product performance and safety.
All medical device establishments, including manufacturers, importers, and distributors, must maintain up-to-date distribution records to effectively manage their products and respond to regulatory needs.

Medical Device Recall

Medical device recalls are crucial for ensuring the continued safe use of products and form an important part of the medical device post-market surveillance in Malaysia.

Voluntary Recall: This action is initiated by the establishment after identifying a defect in the medical device, which may:

  • Pose a hazard to health.
  • Fail to meet claims of effectiveness or safety made by the manufacturer or Authorised Representative.
  • Not comply with legal requirements.
Mandatory Recall: The MDA has the authority to order a recall if a medical device presents a significant public health risk, as outlined in Section 42(4) of the Medical Device Act 2012 (Act 737). The establishment is responsible for executing the recall, with the MDA overseeing and potentially assisting in the communication process.

Factors the MDA may consider when assessing a device for mandatory recall include:

  • The occurrence and likelihood of serious illness or injury.
  • Clinical conditions that could exacerbate health risks.
  • The impact on vulnerable populations (e.g., children, the elderly, immunocompromised individuals).
  • The availability of alternative treatments and the risks of discontinuing use.

Navigating post-market surveillance in Malaysia can be challenging, but Andaman Medical is here to streamline the process and ensure you stay fully compliant with ease. Connect with our experts today and take the first step toward hassle-free compliance!

Why Choose Andaman Medical for Your Medical Device Post-Market Surveillance in Malaysia

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