The Medical Device Authority (MDA), Malaysia’s agency for regulating medical device manufacturing, importation, and distribution, issued guidelines for the registration of drug-device and device-drug combination products.
Current Regulation for Drug Medical Devices and Related Issues
Combination products are specific types of medical devices that contain a medical substance that is required in order for the device to be used as intended by the manufacturer. Existing classification is based on the primary mode of action (PMOA) defining the particular prevailing feature of the product. There are two approaches to the regulation of the drug medical device / medical drug-device combination products at the moment, and there are also two authorities regulating the operations with such devices utilizing two separate acts. Nowadays, these two approaches are the following:
- Regulation under the Control of Drugs and Cosmetics Regulations carried out by the Drug Control Authority or the National Pharmaceutical Regulatory Agency (NPRA) – a special body responsible for medical substances, and
- Regulation under the Medical Device Act 2012, performed by the Medical Device Authority (MDA), which also issues its regulations related to medical devices.
To deal with the discrepancies, caused by the existing approaches to the regulation, the MDA issued special guidance. The guidance is also intended to provide medical device manufacturers with the information on the application requirements, the details on the application procedures, and also about the actions necessary to make changes to the application submitted previously. At the same time, it is important to notice that the provisions of the regulations listed above should prevail anyway.
To distinguish the devices containing medical substances, regulating authority introduced the definitions based on the PMOA:
- Drug-Medical Device Combination Product is the device whose primary action is based on the action of the medical substance.
- Medical Device-Drug Combination Product is the device whose primary action is performed by the medical device itself, while it could be assisted by the medical substance.
The guidance also defines the combination product as a product containing two or more components that are subject to regulation. A combination product could be also defined as several products packaged and provided together.
Combination Product Registration
Due to the specific nature of the combination product that contains both a medical substance (drug) and device, the registration procedure involves two authorities: both the MDA and the NPRA. To define the agency that would be primary for the particular device, the device manufacturer shall define the PMOA first. According to the definition provided in the guidance primary agency is the agency with primary responsibility for the combination product.
According to the existing framework, the registration process includes the following steps:
- Secondary agency stage
- Manufacturer files the application to the secondary agency (depending on the PMOA),
- Secondary agency performs an evaluation of the application. At this step, additional information may be requested,
- In case of success, secondary agency issues Endorsement letter.
- Primary agency stage
- Manufacturer files the application to the primary agency,
- Primary agency evaluates the application submitted and requests additional information if necessary.
- In case of success, primary agency issues final Approval allowing the manufacturer to place the device on the market.
At the same time, there are special exclusions from the general rules regulating the registration procedure. Drug-Medical Device Combination Product should be exempted from the MDA evaluation and would not require Endorsement letter issued by the MDA in case if it contains low risk ancillary medical device components or such components have been already approved by the MDA (in such case, the application to the NPRA should include the confirmation of the MDA approval).
To initiate the approval procedure, at the first stage, an applicant should submit an application form and an ancillary dossier. In the second stage, an applicant should submit an endorsement letter issued by the secondary agency and the data on the primary component depending on the PMOA of the particular product. It is important to mention that data on the medical device component should be submitted to the MDA via the MeDC@St system.
The timeline depends on the role of the regulating agency during the registration of the particular device. If the MDA acts as a secondary agency, it takes from 90 to 180 days (depending on the presence of approval in reference countries) to evaluate the application, while in case when the MDA acts as a primary agency the evaluation procedure for A, B, C and D classes of medical device would take 30, 100, 180 and 22 days respectively. If the NPRA acts as a secondary agency, the evaluation process would take from 90 to 245 days (depending on the type of the particular substance). In case if the NPRA acts as a primary agency, the evaluation would take from 210 to 245 days.
The fees payable should be calculated depending on the type of each component and paid separately together with the application submission. All fees are non-refundable.
Amending the Existing Combination Product Registration
The guidance also provides details on the procedures necessary to make changes to the existing registration of the combination products.
To make changes to the medical device component of the Drug-Medical device combination product, the manufacturer shall submit a notification letter and the Endorsement letter issued previously to the MDA. The approval letter received from the MDA should be forwarded to the NPRA to notify the agency of the changes made.
To make changes to the drug component of the Medical Device-Drug combination product, the manufacturer shall submit an application letter for approval of changes or the variation application to the NPRA.
In case if it is necessary to make changes to the primary component of the combination product, the relevant procedure for the appropriate type of medical product should be applied.
The guidance also contains the list of documents to be included in medical devices or drug dossiers. Ancillary medical device dossier should include the description of the device and its accessories, instructions for use and labeling, warnings and information on potential adverse effects, description of materials used, clinical evidence and risk analysis, and also manufacturing information. At the same time, ancillary drug dossiers should include documents containing general information, such as combination product particulars and drug formulas, information on the quality of drug components, clinical documents including clinical overview and summary, and also the detailed clinical study reports.
The MDA also provides the application forms for each type of submission including the initial application for each type of combination product and also for making changes to an existing registration.
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