The new article describes in detail the aspects related to registration that combination products should undergo in order to be allowed for marketing and use in the country.
The Medical Device Authority (MDA), a Malaysian regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the drug-medical device and medical device-drug combination products. The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be considered by medical device manufacturers 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, but rather to assist the parties involved in achieving and sustaining compliance with the respective regulations. The recommendations provided in the guidance could be subject to changes, should such changes be reasonably necessary to reflect corresponding amendments to the underlying regulations.
The scope of the guidance covers the most important matters related to combination products and regulatory procedures associated thereto including, inter alia, their registration and post-marketing surveillance conducted in order to ensure their continuous safety and proper performance within the whole period of the intended life.
Registration Process: Key Points
First of all, the authority states that the primary agency to be responsible for the registration of a combination product should be determined based on the primary mode of action/ the principal mechanism of action by which the product achieves its intended purposes. The factors to be considered when determining the regulatory nature of the product and the primary agency include the following ones:
- Drug is based on pharmacological, immunological or metabolic action in/on the body; shall be regulated by NPRA;
- Medical device does not achieve its primary mode of action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its intended function by such means; shall be regulated by MDA.
The guidance provides a flowchart describing the registration process for each type of products. According to this flowchart, the very first step should be applying for an endorsement letter for the ancillary component. Hence, the secondary authority will be the one reviewing the application first. Once the said endorsement letter is obtained, the application should be subject to review by the primary authority. When making a decision on approval/granting an endorsement letter, each of the authorities will carry out its own evaluation.
The document further describes each of the procedures in detail and provides additional clarifications and explanations. The key points to be considered include, inter alia, the following:
- Applicant may submit application for endorsement letter and registration of combination product concurrently to both primary and secondary agency. However, the approval of combination product registration is subject to primary agency based on the fulfillment of registration requirements, as well as the receipt of endorsement letter from the secondary agency.
- Stage 1 Obtaining Endorsement from MDA for Drug-Medical Device Combination Product is not required for:
- Low-risk ancillary medical device components;
- Non-sterile and non-measuring low-risk ancillary medical device that form a single entity / integrated product;
- Ancillary medical device components that have already obtained registration approval from MDA.
- Stage 1 Obtaining Endorsement from NPRA for Medical Device-Drug Combination Product is not required for non-invasive (external use and/or localized effect) medical devices.
Drug-Medical Device Combination Product Registration
Apart from the general overview of the registration process for both types of medical devices, the authority outlines the most important aspects to be considered by manufacturers with respect to each of the registration flows.
In accordance with the flowchart, registration of a medical device-drug combination product includes two steps:
- Obtaining an endorsement letter to be issued by MDA; and
- Application for registration to NPRA.
Both these stages are mandatory unless the exclusions described hereabove apply.
When applying for an endorsement letter, the applicant should submit to MDA the following documents:
- Application form (the guidance also provides a template to be used); and
- Ancillary Dossier.
When conducting its review, the authority is entitled to request the applicant to provide additional documentation or a sample of the product under review, and such a request should be fulfilled by the applicant within 90 days. Should the applicant fail to provide the information requested within the period initially indicated by the authority or any extension period granted (if applicable), the application will be deemed withdrawn, and the entire registration process would have to be restarted from the very beginning.
During the second stage, the applicant should submit an application for product registration to NPRA being the primary agency. The said applications should contain the following documents:
- Endorsement letter issued by MDA; and
- Data on the drug the combination product in question contains.
The approval will be granted upon successful review of the application.
When placing the product on the market, the registration holder may refer to the product registration approval notification provided by the authority, or to the Approved Product Registration List on the NPRA website.
Medical Device-Drug Combination Product Registration
The document also describes in detail the process and procedures to be followed in the course of registration of medical device-drug combination products. As previously explained, the registration process is comprised of two steps which include obtaining an endorsement letter from the secondary authority (being NPRA in the case of medical device-drug combination products) and application for registration to the primary authority (in this case – MDA). Both these stages should be completed unless an exclusion described hereabove applies.
All the processes and procedures applicable are similar to the ones for the registration of drug/medical device combination products, apart from being inverted.
In summary, the present MDA guidance describes in detail the process of registration of combination products. The document highlights specific aspects to be considered with respect to each type of combination products and provides an overview of the registration flows.
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