The Medical Device Authority (MDA), a Malaysian regulating authority in the sphere of healthcare products, has published the guidelines for drug-medical device and medical device-drug combination products. The scope of the guidelines covers, inter alia, the aspects related to the endorsement letter application and adverse drug reaction and incident reporting. The guidance is intended to provide an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be considered in order to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance should such changes be reasonably required to reflect corresponding amendments to the underlying regulations.; the authority is also entitled to request additional information and documentation beyond the scope outlined in the present guidance, should this be reasonably necessary to validate the safety and effectiveness of the device in question. Furthermore, in case of any discrepancies with the provisions of the underlying regulations, the latter should prevail.
First of all, the authority highlights the most important aspects to be taken into account with respect to combination products allowed for marketing and used in the country. As explained by the MDA, the classification of such products would depend on the primary mode of action (PMOA) which is one of the most important concepts used in the context of combination products. Depending on the component associated with the PMOA, combination products could be regulated either as a drug (by Drug Control Authority), or as a medical device (in such a case, MDA will be the agency responsible).
Terms and Definitions
In order to assist the parties involved with interpretations of the rules and requirements prescribed by the applicable legislation, the authority provides definitions of the most important terms and concepts used. This includes, inter alia, the following ones:
- Approval letter – a document that is issued by the secondary agency after satisfactory review of the changes/variations to particulars of a registered combination product.
- Endorsement letter – a document issued by the secondary agency after satisfactory review of the ancillary component.
- Ancillary Dossier – the one required by the secondary agency.
- Secondary Agency – the one that regulates the other part(s) included in the combination product.
- Primary Agency – the one with primary regulatory responsibility for a combination product which is determined by the primary mode of action of the product.
- Primary Mode of Action – the one that provides the greatest contribution to the overall therapeutic effects of the combination holder.
- Drug-Medical Device Combination Product (DMDCP): primary mode of action is based on pharmacological, immunological or metabolic action in/on the body where MPRA is the primary agency of the combination product.
- Medical Device-Drug Combination Product (MDDCP): primary mode of action in or on the human body is not based on pharmacological, immunological or metabolic means, but that may be assisted in its intended function by such means where MDA is the primary agency of the combination product.
The guidance also provides definitions for such terms as “establishment”, “incident”, “primary dossier”, and “product registration holder”.
Apart from the general terms and concepts, the authority also provides full definitions of a drug and a medical device since they are used to determine the regulatory nature of the product in question. In addition to this, the document provides a definition of a combination product which, according to the guidance, covers:
- Products comprised of at least two components subject to regulation under different frameworks, provided they are combined or mixed, and offered as a single entity; or
- At least two separate products supplied together in the same package or as a unit.
The authority also outlines the scope of exclusions, notifying that such products should be regulated separately due to their nature and specific features. According to the guidance, the following exclusions apply:
- The products are packaged separately but intended to be used together in accordance with the documentation provided by manufacturers or the applicable investigation plan, both having similar indications for use and designed to achieve the effect when used together.
- Investigational drugs and devices, are packaged separately but intended to be used together.
- Convenience pack products (as further explained by the MDA, this includes first aid kits that contain medical devices).
- Natural and health supplement products.
The authority additionally emphasizes that before taking any actions or commencing any process, a party responsible for the product should determine its legal nature and regulatory framework to be applied. Before applying for registration required in order to be allowed to market the product in the country, an interested party may submit a request to the authority, asking for classification. Such a request could be submitted via the appropriate request form.
In summary, the present MDA guidance describes in detail the regulatory approach the authority applies with respect to combination products depending on their principal mode of action and corresponding determination of the regulatory status. The document explains the idea behind the key term and concepts, and also highlights the most important aspects to be taken into consideration by the parties involved. Apart from that, the authority provides an overview of the existing regulatory framework for both drugs (medicines) and medical devices, and names the authorities responsible for each type of products.
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