India’s Ministry of Health (MoH) provides grouping guidance for medical devices based on Medical Device Rules (MDR) 2017. Grouping allows for a simplification of the application process, which in turn, is more cost effective and time saving for the manufacturer.
To be grouped together, the products will need to adhere to the specific rules to belong to certain categories.
The different grouping categories are as follows:
IVD Test Kit
Grouping Definitions, Examples, and Regulatory Requirements
A Single device that ranges in package size and/or number of units. There are separate documentation and fee requirements for each single device.
A Family consists of products that have a common risk classification, license holder, intended use, design, and manufacturing process, but may slightly differ from each other. Permissible variants can also apply (see below). There is a single fee for a family, and a common Device Master File (DMF).
i) Anticoagulants with the same composition but different concentrations
ii) Additives (different composition and concentrations)
i) Number of lumens in catheter
ii) Material of catheter: PVC (polyvinylchloride), PU (polyurethane), nylon, and silicone
iv) Coating material for lubrication
Automatic or semi-automatic
Material of bracket
i) Rotational speed
ii) Material of handpiece
i) Electrode Spacing
ii) Number of electrodes
Powered or powder-free
With or without inert coating material
Orthopedic/ Dental Implants
i) Cemented or non-cemented fixation
i) Monofocal or Multifocal
ii) Multi-piece or Single-piece
iii) Aspheric or Spheric
Implantable Pulse Generators
Number of Chambers (Cardio)
i) Presence of injection port
ii) Presence of safety wing
With or without plasticizers (e.g., DEHP)
i) Delivery system, that is over the wire or through the scope
Different formats (e.g., solution, creams, gels loaded onto pads, etc.)
A System contains accessories that work in combination with the medical device to achieve a common intended purpose. They also have a common license holder and are sold under the same proprietary system name. Systems sold and imported as a single unit package can register under a single application and fee. Separate documentation will be requirement for the different components within the system. However, if the manufacturer wants to sell the system both as a single unit package and individual components, separate fees and documentation apply.
A Group consists of 2 or more medical devices that are imported and sold in the same packaging under a common license holder (different manufacturers are allowed) with the same intended purpose. It must also be sold under the same proprietary system name. There is a single fee for a group, and separate documentation for each medical device must be provided.
IVD Test Kits contain reagents and/or articles and are labelled as an IVD test kit and are meant to be used in combination for a common intended purpose. They also have a common license holder and a single proprietary name. These kits do not include analyzers. IVD test kits sold and imported as a single unit can register under a single application and fee. Separate documentation will be requirement for the different components within the kit. However, if the manufacturer wants to sell the kit both as a single unit and individual components, separate fees and documentation apply.
And IVD Cluster contain in-vitro reagents and/or articles and have a common license holder and methodology but may have different intended use. They are also sold under a single proprietary name. It may contain two different test kits, reagents, and other articles. There are separate fees for each product but a common DMF.
Contact Asia Actual for more information about India grouping requirements.