Table Of Contents:
The Medical Device Authority (MDA), a Malaysian regulating authority, has published a draft guidance dedicated to the requirements for the application of a Certificate of Free Sale (CFS), Manufacturing Certificate (MC), and Certificate of Free Sale for Export Only (CFS EO) medical devices. The document provides an overview of the procedures to be followed by medical device manufacturers when applying for the aforementioned certificates and also highlights the key points associated thereto. In particular, the document provides additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be followed 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, so in case of any discrepancies with the provisions of the underlying legislation, the latter should prevail.
The scope of the guidance covers, inter alia, the main requirements to be fulfilled for the certificates to be issued, and also describes in detail the application procedure to be followed.
First of all, the guidance outlines the scope of documentation and information to be submitted by an interested party when applying for a certificate to be issued. In particular, the authority explains the way the most important aspects should be addressed.
Medical Device Description
For instance, a description of the medical device in question should include:
- A complete description of the medical device;
- Principles of operation or mode of action;
- Risk class and applicable classification rule for the medical device;
- A description of the accessories, other medical devices, and other products that are not medical devices, which are intended to be used in combination with the medical device;
- A description or complete list of the various configurations of the medical device for CFS/MC application;
- A complete description of the key functional elements;
- An explanation of any novel features;
- Intended use;
- Indications for use;
- Instructions for use;
- Warnings to inform on specific hazard alerts;
- Precautions to exercise special care necessary for the safe and effective use;
- Potential adverse effects or side effects;
- Alternative therapy for diagnosing, treating, curing, or mitigating the disease or condition for which the device is intended;
- Materials used;
- Other relevant specifications and descriptive information.
Manufacturer and Manufacturing Processes
Apart from the information regarding the medical device itself, a request should include information about the medical device manufacturer, as well as the processes applied. In particular, a description of manufacturing processes should be provided in the form of a list of resources used and activities carried out. Such a description should include details regarding the particular methods and procedures applied, facilities participating in the manufacturing process, and also the controls used. As explained by the authority, the details should be sufficient for a person having general knowledge of quality systems to assess whether the controls applied are appropriate. Should the manufacturing process include sterilization, a description of the particular method used should be provided as well. All the information regarding the manufacturing processes could be presented in a form of a flowchart. Should multiple facilities be involved in the manufacturing process, the role each of them takes should be clearly outlined. Furthermore, should new facilities be added, information about them should be duly communicated to the authority. According to the guidance, if the manufacturing process of a product consists of a number of sub-assembly processes, the manufacturing sites where each of these sub-assembly processes are carried out shall be identified, and the relationship between these processes shall be shown; or if multiple sites manufacture the same product, each of these sites shall be identified. Hence, the authority requires proper identification of the facilities when medical device design and manufacturing activities take place. For these sites, Quality Management System (QMS) certificates should be presented. At the same time, the authority also mentions that these requirements are not applicable with respect to the manufacturing of components.
Declaration of Conformity
The document also describes the key elements of a Declaration of Conformity (DoC) which could also be requested from the entities applying for medical device certificates. According to the guidance, the said Declaration should include the following:
- Information about the initial/contract manufacturer of a medical device, including its name and address;
- An attestation that any and all medical devices covered by the scope of the Declaration have been duly classified and are compliant with the applicable regulatory requirements;
- Details of medical devices allowing to identify the ones covered by the Declaration;
- Validity date;
- Information about the applicable standards;
- Attestation on the responsibility and acknowledgment on the false declaration;
- Details about the person authorized to complete the Declaration (should be from the senior management of the company), including the name, position, and signature. The authority further explains that the said requirement applies to persons entitled to make decisions on behalf of the company (e.g., CEO or Managing Director).
The guidance also contains a table where all the important elements of a Declaration of Conformity are listed and explained. In particular, the table describes the way identification information should be provided. According to the table, the authority expects a Declaration of Conformity to contain the following details:
- Generic name;
- Specified name;
- Manufacturer / Contract Manufacturer;
- Manufacturing site;
- Risk-based classification;
- Classification rule;
- GMDN code (if available).
In summary, the present MDA guidance provides additional clarifications regarding the scope of information the authority expects applicants for the medical device certificates to include in the respective submissions. The document also describes in detail the content of a Declaration of Conformity and outlines its key elements.
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