The Medical Device Authority (MDA), a special division of the Ministry of Health Malaysia responsible for medical device regulation, has announced new rules introducing additional obligations for medical device manufacturers and other parties involved in medical device circulation and new advertising requirements.
Duties and Obligations of Establishments
The first of the two documents issued by the MDA establishes the duties and obligations of medical device companies. The stipulations in this document will be put into effect on July 1, 2020. The new regulation introduces two definitions: “incident”, as the event that could cause a negative impact on patient’s health, and “field corrective or preventive action” as an action taken by a manufacturer to reduce the risk associated with the use of a device.
The document also contains a list of obligations that companies involved in operations with medical devices should follow. These include:
- Maintaining distribution records. The whole lifecycle of a medical device including production, import or export, distribution or provision in another way to the end-user should be properly recorded. These records should contain the following information:
- Information about the consignee,
- Specifications of the device,
- Address of the storage place,
- Delivery and receipt information,
- Details about disposal,
- Additional information required by the agency if applicable.
The scope of information that should be recorded could be extended or changed if the device is an implantable medical device. In that case, it is necessary to make sure the information stays related to:
- The healthcare facilities that used the device,
- The particular patient,
- Implantation date,
- Removal date of the device (if applicable).
The information should be kept for either two years after the date of manufacture or export, or within the projected lifespan of medical device if specified by the manufacturer.
- Compliant record. The manufacturer must also keep records of all complaints that have been filed concerning medical devices. In general, the procedures related to complaints include the following elements:
- Complaint assessment,
- Investigation performed by the manufacturer concerning the matter of complaint,
- Actions taken by the manufacturer,
- Communications with the applicant (complainant),
- Records made in the course of the aforementioned actions.
The records related to complaints should contain information on the particular medical device and complaint associated with it, including details on the incident the complaint is based on, and other information necessary for the investigation. Such records should be kept for an additional five years.
- Problem reporting. According to the regulations, the manufacturer must inform the authority about all problems identified as a result of incidents related to the device. In the case of any incidents, the manufacturer must file a report to the authority and then perform the investigation. The results of these investigations should also be submitted to the authority in the form of an investigation report containing a description of corrective actions taken. The authority will review the report and close the matter if the corrective actions taken by the manufacturer are found sufficient. At the same time, the authority is entitled to conduct inspections on its sole discretion. If the authority is not satisfied with the report, it has a right to:
- Require additional investigation,
- Initiate the recall of the medical device,
- Revoke the registration,
- Withdraw the license.
- Field corrective or preventive actions – special measures taken by the establishment in order to prevent potential hazards or reduce the potential harm caused by the device. In such a case, the establishment should notify the authority in advance. The establishment should also submit the appropriate report to the authority which would review the report and contact the establishment in case of any additional measures necessary to be taken.
Medical Device Recall
Under the regulation, the medical device could be recalled either voluntary (by the manufacturer itself) or mandatory (upon demand of the authority). The regulation also implements rules relating to both types of recall procedures.
According to the document, there are three classes of voluntary recall procedure:
- Class I recall – high-risk recall applicable when using the device could cause serious harm to the health of patients,
- Class II recall – medium risk recall for when use of the device could cause temporary or reversible harm or serious harm in the future,
- Class III recall – low risk recall applicable when the use of the device could cause potential harm to the patient’s health.
The manufacturer shall notify the authority and all other parties involved within the terms specified in the document for each particular class of recall. After the completion of recall, the manufacturer shall submit the appropriate report to the authority, while the authority is entitled to request any additional information regarding the recall.
The authority has a right to issue a written demand to recall the device due to safety reasons at any time. In such a case, the manufacturer should perform the procedure required by the authority and report about the results while the authority is entitled either to accept the report if it is sufficient and close the matter or require the manufacturers to take additional measures. The authority also has the right to suspend the registration of the particular medical device or suspend or revoke the license of the manufacturer.
According to the rules set forth by the regulation, failure of the manufacturer or another establishment to perform its obligations related to maintaining records, reporting adverse events, taking corrective actions or conducting the recall allows the authority to impose sanctions for both violating company and its key officials. Depending on the particular subject, the punishment could be in a form of financial penalty or imprisonment.
Medical Device Advertising Regulation
Another important regulation issued recently by the MDA relates to the advertising requirements applicable to medical devices. According to the new regulation, any medical device advertising is allowed only if approved by the authority in advance. To obtain the approval necessary to advertise the registered medical device, the interested party has to submit an application to the authority accompanied by the following information:
– Copy of advertising materials,
– Confirmation of application fee payment,
– Letter of appointment if an applicant is an authorized representative of the establishment.
The authority is also entitled to request any additional information reasonably necessary to review the application. The regulation also establishes the requirements applicable to the content of the advertisement. In accordance with these requirements, the advertisement shall contain:
– The certificate confirming that the particular device is registered, and
– The registration number assigned to the device when being registered by the authority.
Anyone failing to comply with these requirements would be liable and subject to financial penalties or imprisonment.
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