The Malaysian Medical Device Authority (MDA), Malaysia’s agency responsible for regulations in the sphere of healthcare products, has published draft guidance dedicated to the general medical device grouping. The document was published on the official website and made available for public comments.
Regulatory Background
The present MDA guidance is based on the Medical Device Act (Act 737), Medical Device Regulations 2012, and is intended to provide medical device manufacturers and other parties involved in operations with medical devices with the additional clarifications regarding the requirements set forth therein.
The MDA additionally mentions that it is entitled to request medical device manufacturers provide additional documents, other than specified in the applicable regulations, in case if such documents are reasonably necessary to conduct the assessment. The authority also reminds that in case of any discrepancies between the recommendations provided in the present guidance, and in the applicable legislation, the provisions of the latter shall prevail. The MDA may update the guidance or make any changes at any time at its sole discretion, so the medical device manufacturer shall ensure it is aware of the latest changes.
According to the general rule, any medical device intended to be marketed in Malaysia should be registered with the national regulating authority. This rule covers importing, exporting, or placing the medical device on the country’s market in any way. As it is stated in the guidance, the products could be placed on the market as separate components, individually customized packs, or groups. The applicable legislation distinguishes the following categories:
- Single (medical device),
- Family,
- System,
- Set.
When submitting the initial application, the medical device manufacturer or its authorized representative responsible for the device should indicate the appropriate category the device should be assigned to.
The present MDA draft guidance is intended to clarify the way such determination should be made in the context of the application for medical device registration.
The scope of the guidance covers any and all medical devices meeting the criteria outlined in the appropriate definition of a medical device set forth by the Guidance Document: Definition of Medical Device (MDA/GD/0006) excluding In-vitro Diagnostic Medical Device.
The draft guidance provides the definitions of the most important terms used including, inter alia, the following ones:
- Component – one of several possibly unequal subdivisions that together constitute the whole medical device to achieve the latter`s intended purpose. A component may be known as a part but not a medical device in its own right.
- Proprietary name – a unique name given by the manufacturer to identify a medical device as a whole product, also known as the trade name or brand name.
- Registration holder – in a relation to a registered medical device, means an establishment on whose application the medical device is registered under the Act. A registration holder is either the manufacturer or authorized representative of the medical device [manufacturer].
General Principles of Grouping
As it was already mentioned before, there are four main categories a medical device could be assigned to. According to the draft guidance, there are three rules to be followed with regard to grouping, namely:
- One proprietary name,
- One manufacturer; and
- One common intended purpose.
A single medical device is usually marketed separately and could be used independently for the particular intended purpose. The MDA additionally emphasizes that even if the package contains more than one similar device, each of them should be deemed as a single medical device, irrespectively of the package size. Another example provided by the regulating authority describes software that could be used on various equipment. In such a case, such software should be treated as a separate product and could be registered accordingly. The MDA further describes that in case if a medical device manufacturer would decide to separate the first aid kit and market the products it contains separately, each of the medical devices contained therein should be registered as a single medical device.
The document also clarifies the concept of a system. According to the draft guidance, a medical device system consists of several components, that are:
- Manufactured by the same manufacturer,
- Initially intended to be used together for a common intended purpose,
- Compatible with each other, and
- Being marketed under a medical device system name, and all documentation supplied with the device, including the labeling or instructions for use, contains indications that these components are intended to be used together as a system.
Another important concept used in the context of medical device grouping is a medical device family – a collection of medical devices, in which each of the devices:
- Is manufactured by the same entity,
- Belongs to the same class under the risk-based classification,
- Is being marketed under the same proprietary name,
- Has a common intended purpose,
- Has the same design and manufacturing process, and
- May have certain variations that are still falling within the scope of permissible variants.
The draft TGA guidance also describes the characteristics of a medical device to be considered a permissible variant, namely:
- A physical design and construction of the medical devices are the same, or very similar,
- The manufacturing process for the medical devices are the same, or very similar,
- The intended purpose of the medical device is the same, and
- The risk profile of the medical device, taking into account the above factors, is the same.
Thus, a medical device family may include medical devices different in color or size, but composed of the same materials and manufactured by the same manufacturer.
According to the applicable regulations, the information the medical device manufacturer or its authorized representative shall submit with regard to a medical device family should include the information on any and all medical devices a family includes.
The document also describes the concept of a medical device set, defined as a collection of two or more medical devices, assembled together as one package by a manufacturer. According to the guidance, a medical device set has a single proprietary set name and common intended use. It is important to mention that the class of a medical device set would be the highest class of the device such a set contains.
Additional Rules and Requirements
The MDA draft guidance on medical device grouping also provides certain device-specific recommendations to be applied in case if the general rules do not take into account the features of the medical devices in question. For instance, the document provides special grouping rules for In Vitro Fertilisation (IVF) Medical Devices, hearing aid products, and dental medical devices. The document also contains detailed flowcharts describing the appropriate procedures to be applied when determining the category the products subject to review should be assigned to.
Summarizing the information provided here above, the present MDA draft guidance on medical device grouping describes the applicable rules and also provides certain clarifications and recommendations the industry representatives shall follow when applying them. The guidance also outlines the particular classification criteria to be applied depending on medical devices, their features, and intended purpose.
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