The Medical Device Authority (MDA), a special body of the Ministry of Health Malaysia responsible for medical device regulations, issued guidance on field corrective actions.
Malaysian Medical Devices Regulatory Background
The present MDA guidance is intended to provide medical device manufacturers and other parties involved in operations with information regarding maintaining compliance with the Medical Device Act – the country’s main regulation in the sphere of medical devices. In particular, the MDA guidance on filed corrective actions is based on the following legislative acts:
- Medical Device Act 2012 (Act 737),
- Medical Device Regulations 2012,
- Medical Device (Duties and Obligation of Establishments) Regulations 2019.
In the introduction to the guidance, the authority also mentions that it is entitled to request any additional information it will deem necessary. Another important point is related to the applicability of the guidance – in case of any discrepancies between the provisions of the guidance and the appropriate rules set forth by the current legislation, the latter should prevail.
As it was mentioned above, the present MDA guidance is dedicated to the field corrective actions (FCA) – special actions to be taken by the medical device manufacturer and/or other parties in order to mitigate or prevent hazards caused by the medical devices. According to the document, medical device manufacturers or their authorized representatives (in case of foreign medical device manufacturers marketing their devices in Malaysia) should take all necessary actions to reduce the harm that could be caused by the device when used for the intended purpose.
Usually, field corrective actions constitute a manufacturer’s response to the information collected in the course of post-market surveillance, including adverse event reports or complaints filed by healthcare professionals or patients directly using the device. Thus, FCAs are safety-related actions to be taken by the entity properly placed on the Malaysian medical devices market to prevent adverse events or mitigate their consequences.
It is also important to mention that FCA is an equivalent of the field safety corrective action (FSCA) as prescribed by the Asean Medical Device Directive (AMDD).
Malaysian Regulations on FCA: Key Points
The MDA guidance on field corrective actions provides the definitions of the most important terms, namely:
- Corrective action – action to eliminate the cause of nonconformities to prevent a recurrence,
- Field safety notice (FSN) – a communication sent out by an establishment to the medical device users in relation to an FCA,
- Incident – an event that causes, or has a potential to cause, unexpected or unwanted effects involving the safety of any person who uses a medical device or any person associated with the use of a medical device,
- Preventive action – action to eliminate the causes of potential nonconformities in order to prevent their occurrence.
According to the MDA guidance, the establishment is obliged to take special actions related to the medical device properly placed on the market in case if such a device creates hazards to patients and users. The actions to be taken by the establishment could include, inter alia, the following ones:
- Recall (request to return a device),
- Modifications to the device to eliminate the nonconformity (e.g. changes to the device itself, its software or instructions for use),
- Replacing medical device,
- Destruction of the device,
- Providing special recommendations regarding the use of the device in a safe and effective way.
The MDA states that under the general rule, the medical device manufacturer shall determine whether the field corrective actions are needed. According to the document, FCAs could be based on:
- The results of the risk assessment performed by the medical device manufacturer in accordance with the requirements set forth in the International Standard ISO 14971. It is also important to mention that the MDA could require the manufacturer to take additional steps in case if the risk assessment would be found insufficient.
- The information collected in the course of post-marketing surveillance indicating the unacceptable risk associated with the use of the device for the intended purpose.
The authority also mentions that it is entitled to require the manufacturer to take additional actions in case of serious harm caused by the device to the patient’s health.
The guidance also describes the way the medical device manufacturer shall plan and implement filed corrective actions. In particular, the manufacturer shall duly notify the MDA about planned FCAs in advance. The guidance provides the following rules related to notifications:
- Foreign medical device manufacturer shall immediately notify its local authorized representative in Malaysia about the FCAs to be taken,
- In the case of domestic medical device manufacturer exporting its products abroad, all relevant national authorities should be informed accordingly,
- Upon completion of the corrective actions, the establishment shall notify the MDA within 30 days (unless the authority allows extending such period).
The report to be submitted by the manufacturer shall include the information reasonably necessary for the authority to assess the case. This information should include:
- Details about the medical device manufacturer or its authorized representative,
- Risk analysis details,
- Indications of the underlying reasons for the field corrective actions,
- Health hazard assessment,
- Justification of the actions and additional details,
- Recommendations regarding the actions the distributor or user shall take.
The MDA will review the report, evaluate the sufficiency of the actions taken by the establishment, and close the issue if it will find such corrective actions as sufficient. The authority will also notify the manufacturer about the decision taken in writing.
Field Safety Notice (FSN)
The guidance also provides details regarding the field safety notices to be sent by the manufacturer in order to inform other parties about the actions to be taken regarding the medical device subject to FCA. Such notice could also contain a request to transmit the information it contains to other parties it may concern (within the organization). To send the FSNs, the establishment should use the distribution records. It is also important to take all necessary measures to obtain a confirmation of safe receipt of such communication by the party it was addressed to, while the authority reserves the right to check whether the information has been provided and duly received. The MDA is also entitled to require the medical device manufacturer or its authorized representative to make certain changes to the FCA risk communication of FCA strategy, in case it is reasonably necessary due to the nature of the field corrective actions. It is also advised to provide the same information to the conformity assessment body that has performed the initial conformity assessment of the device in question. It is strictly forbidden to play down the level of risk or advertise any products.
According to the guidance, the field safety notice shall contain:
- the indication of the commercial name of the product, the type of action to be taken,
- information that is necessary to identify the particular medical device subject to field corrective action (e.g. type of the device, serial and/or batch numbers of affected devices),
- explanation of the reasons for corrective actions, including the details on defects and hazards associated thereto,
- recommendations regarding the particular actions to be taken,
- request to provide additional information about the devices,
- contact information,
- the acknowledgment form.
According to the guidance, besides the initial FSN served in paper form, the copy should be provided via email.
Summarizing the information provided hereabove, the MDA guidance on field corrective actions describes the way such actions should be performed by the establishment responsible for the device, and also the requirements related to the field safety notices.
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