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Market Surveillance & Reporting

Regulatory Intelligence Report

Establishing a presence in a new market poses significant challenges, particularly in the realms of marketing and sales.

However, prior to reaching that stage, it is imperative to diligently address all regulatory prerequisites and conduct comprehensive due diligence. This holds true whether the device in question is an existing product already registered in other regions and bears similarities to items available in the target country, or if it is a completely novel medical device or in vitro-diagnostic (IVD) tool.

The intricate nature of the regulatory landscape can be overwhelming, necessitating a thorough understanding of the procedures and requirements applicable to the specific medical device or IVD under consideration.

Regulatory Intelligence for Medical Devices and In Vitro Diagnostics (IVDs)

Acquiring a comprehensive regulatory intelligence report is crucial for effectively navigating the complexities associated with bringing your product to market. This report encompasses a wide range of vital information, from ensuring compliance with documentation requirements and conducting gap analyses to addressing labelling and (pre)clinical testing prerequisites.

Additionally, it covers essential aspects like obtaining market access licenses and exploring possibilities for fast-track authorizations.


The key components of the regulatory intelligence report are as follows:

  1. Regulatory classification of the medical device or IVD.
  2. Reference of applicable legislation.
  3. Responsible bodies for market legislation (e.g., telecommunications licenses, drug products, controlled substances).
  4. Registration, change notifications, or license transfer process details and timelines.
  5. Cost (fees) of registration, change notification, or license transfer.
  6. Labelling requirements.
  7. Testing requirements for product registration:
    I. Required tests (in vitro or in vivo).
    ii. Responsible parties for tests.
    iii. Standards to follow.
    iv. Testing location restrictions (e.g., mutual acceptance of data from other jurisdictions).
  8. Potential issues/claims affecting regulatory classification.
  9. Market access requirements: Local Authorized Representative, import/export restrictions, customs, duties, price controls.
  10. Fast-track market authorizations (e.g., due to COVID-19 crisis) with timelines and temporary status details.
  11. Post-market surveillance requirements.
  12. Medical device clinical trial requirements, protocol, and authorizations.

Malaysia’s Regulatory Authority and Laws

Medical devices and in vitro-diagnostic devices (IVDs) in Malaysia are subject to regulation by the Medical Device Authority (MDA), which operates as a federal statutory agency under the Ministry of Health (MoH).

The primary aims of the Medical Device Act 2012 (Act 737) and the Medical Device Authority Act 2012 (Act 738) are to ensure public health and safety concerning these devices while promoting growth and efficiency in the medical device trade and industry.

The MDA is responsible for the implementation and enforcement of these acts to achieve their intended objectives.

Post Market Surveillance of Medical Devices

As a medical device manufacturer, it is imperative that both you and your designated local dealers undertake Post-Market Surveillance (PMS) activities to ensure the highest quality standards and thoroughly evaluate the safety, performance, and effectiveness of the medical devices.

In adherence to the regulations set forth by ASEAN member countries, each nation has implemented its own Post Marketing Alert Systems (PMAS). Our competent in-house staff will support you in maintaining compliance in each country where your medical devices are made available in the market.

Mandatory Problem Reporting

The Medical Devices (Duties and Obligations of Establishment) Regulations 2019 outline the comprehensive requirements for post-market surveillance and vigilance concerning all medical devices in Malaysia, as mandated under Chapter 3 of the Medical Devices Act 2012 (Act 737). These regulations are established with the purpose of ensuring that manufacturers, importers, distributors, and local authorized representatives fulfill their responsibilities in actively monitoring and consistently ensuring the safety and performance of medical devices introduced into the market.



As a member country of the Association of Southeast Asian Nations (ASEAN), Malaysia adheres to the provisions of the ASEAN Medical Device Directive (AMDD), which took effect on January 1st, 2015. This alignment with the AMDD reinforces Malaysia’s commitment to upholding regional standards and harmonizing post-market surveillance practices for medical devices within the ASEAN community.

 

In accordance with the ASEAN Medical Device Directive (AMDD), mandatory problem reporting, also known as Adverse Event (AE) reporting, constitutes an essential post-market risk assessment measure aimed at ensuring the ongoing safe usage of medical devices within the framework of post-market surveillance.

 

The obligations under mandatory problem reporting include:

 

1. Submitting a mandatory problem report to the Malaysian Medical Device Authority (MDA) whenever an incident related to a medical device occurs, whether within or outside Malaysia, provided that the medical device is registered in Malaysia* (refer to the details below).

2. Conducting a thorough investigation to determine the root cause of the incident.

3. Implementing Corrective and Preventive Actions (CAPA) to effectively mitigate or eliminate the risk of a similar incident recurrence.

 

The MDA will meticulously assess the investigation report, and if both the report and the actions taken are deemed satisfactory, the MDA will communicate in writing to the establishment, acknowledging the resolution of the matter.

 

*Please refer to the specific registration guidelines for clarity on the applicability of mandatory problem reporting to medical devices registered in Malaysia.

 

In compliance with regulations, establishments are obligated to provide a standardized complaint submission form for matters concerning their medical device. Clear and precise instructions should accompany the form to guide users on the designated channels for complaint submission. Complaints may emanate from diverse users of the medical device, encompassing patients, home users, healthcare practitioners, maintenance providers, and the general public. Maintaining an efficient and accessible complaint handling system is crucial for ensuring prompt and effective resolution of any concerns related to the medical device.

 

 

Field Corrective Actions, also known as FSCA in the ASEAN Medical Device Directive, are triggered by post-market surveillance data like complaints, incidents, and market surveys. The MDA may require FCAs even for discontinued devices still in use. The goal is to mitigate risks, including the potential for severe health issues or death. FCAs encompass measures like recalls, modifications, exchanges, device destruction, and specific usage advice to ensure patient safety and product quality.


Field Corrective Actions are implemented with the objective of mitigating the potential risk of death or serious health deterioration associated with the utilization of a medical device. These actions encompass several measures, including:

 

1. Medical device recall
2. Device modification to rectify potential nonconformists, encompassing retrofitting, adjustments to labeling or instructions for use, software upgrades, or modifications to patient clinical management
3. Medical device exchange
4. Medical device destruction
5. Provision of specific advice by the establishment concerning the appropriate usage of the medical device.

 

Recall is an integral component of the post-marketing risk assessment approach, essential for ensuring the ongoing safe usage of medical devices and plays a crucial role in the post-market surveillance system.

 

Voluntary Recall
A voluntary recall refers to the proactive measures undertaken by the medical device establishment to remove the device from the market or retrieve it from any individual who has received it. This course of action is initiated once the establishment becomes aware of the device's defectiveness or potential defectiveness, in the following scenarios:

1. When the device is found to pose potential hazards to health.

2. When the device fails to align with any claims made by the manufacturer or Authorized Representative regarding its effectiveness, benefits, performance characteristics, or safety.

3. When the device does not meet the requirements stipulated by the law.

 

The primary objective behind is to promptly address these issues, thereby ensuring the well-being and safety of users and maintaining compliance with applicable regulations.

 

Mandatory Recall
As per section 42 (4) of the Medical Device Act 2012 (Act 737), the Medical Device Authority (MDA) holds the authority to issue a medical device recall when there exists a significant risk to public health associated with the device in question. The establishment responsible for the medical device is obligated to execute all necessary recall procedures, as stipulated in Clause 3. Throughout the recall process, the MDA will oversee and monitor the proceedings, and if deemed necessary, may engage with relevant stakeholders to ensure effective communication and resolution.

 

The Authority's assessment of a medical device under consideration for mandatory recall encompasses various factors, such as:

 

1. Incidents of serious illness or injury resulting from the device's use, and the likelihood of further occurrences if continued usage persists.

2. Existing conditions that could contribute to clinical situations posing health hazards to the public.

3. Potential hazards specific to vulnerable groups (e.g., children, the elderly, surgical patients, immune-compromised individuals), and the severity of health risks they may face.

4. Reports of serious illnesses and injuries linked to the device, with the establishment aware of the risk but not taking voluntary action.

5. Availability of alternative treatment options, including the risks associated with no treatment if alternatives are unavailable.

 

These factors play a crucial role in the Authority's assessment for the potential implementation of a mandatory recall action to ensure the protection of public health and safety.

 

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