In-vitro diagnostic medical device product grouping in Malaysia
The Medical Device Authority (MDA) in Malaysia released the second edition of a guidance document on In Vitro Diagnostic Medical Device Product Grouping (MDA/GD/0054). IVD devices are regulated medical devices in Malaysia.
IVD devices can include, for example, reagents, calibrators, sample collection and storage devices, control materials and related instruments or apparatus. The information provided by an in vitro diagnostic device may be for diagnostic, monitoring or compatibility purpose.
MDA/GD/0054 guides manufacturers on how to group IVD products together for submission as one application for medical device registration and listing in the Malaysian Medical Device Register (MMDR). In vitro diagnostic medical devices can be grouped into one of the following five categories:
- IVD TEST KIT
- IVD CLUSTER.
The following three rules must all be fulfilled for the product grouping to apply. These are:
- one proprietary name
- one manufacturer (this may be the company headquarters) and
- one common intended purpose.
A SINGLE IVD medical device is identified by a medical device proprietary name from one manufacturer with a specific intended purpose. It is sold as a distinct packaged entity. It may be offered in a range of package sizes and one device with multiple identifiers (e.g., part no, article no, material no.) for the same medical device.
IVD devices that can be grouped as a SYSTEM comprise a number of constituent components, that are:
- from the same manufacturer
- intended to be used in combination to complete a common intended purpose
- compatible when used as a SYSTEM and
- are sold under a SYSTEM name or the labeling, instruction for use (IFU), brochures or catalogues for each constituent component states that the constituent component is intended for use with the SYSTEM.
An in vitro diagnostic medical device SYSTEM may typically consist of TEST KITs and instruments (e.g. an analyzer designed to be used with the TEST KIT) – see information on TEST KITs further down.
A medical device FAMILY is a collection of IVD medical devices and each ivd medical device FAMILY member is from the same manufacturer and has the same proprietary name with a specific intended purpose. Each IVD must have the same risk classification and design and manufacturing process and may have variations that are within the scope of permissible variants.
An IVD TEST KIT is an in vitro diagnostic device that consists of reagents or articles that are sold under a single TEST KIT name or the labeling, instructions for use (IFU), brochures or catalogues for each reagents or article states that the component is intended for use with the IVD TEST KIT. The components must be compatible when used as IVD test kits. IVD TEST KITS do not include the instruments, such as analyzers, needed to perform the test.
An IVD CLUSTER comprises of a number of in vitro diagnostic reagents or articles that are within risk classification as Class A or Class B. They must have the same methodology, cluster category and test principles (test principle based on IFU). And IVD CLUSTER may include analyzers that are designed for use with the reagents in the IVD CLUSTER.
Detailed information and examples of all of the IVD product groupings can be found in the guidance document. Besides the grouping for common IVD devices, the MDA also includes the grouping guidance for special IVD devices, such as:
- Immunohistochemistry (IHC) IVD reagents
- Fluorescence in Situ Hybridisation Probes In vitro Diagnostic Reagents.
To enquire about IVD medical device product grouping and registration in Malaysia, please contact us at firstname.lastname@example.org