The Government has set certain grouping guidelines in respect to the Medical Devices Rules 2017,here by notifies that the grouping of medical devices for a person who applies for licence to import or manufacture for sale or distribution of medical devices, namely:-

(l) Application for licence to import or manufacture for sale or distribution, sell, stock or offer for sale or distribution of medical device shall be made as specified under respective Form to the Appendix to Medical Devices Rules, 2017.

(2) The applicant may group medical devices having same or similar intended uses or commonality of technology and submitted in a single application. The grouping of medical devices is for purpose of submission of single application for license to import or manufacture in the following manner:­

Single:

a. A single medical device is a medical device sold as a distinct packaged entity and does not meet the criteria for family, system, group.

b. Separate fee for each single device and separate documentation for each single device.

Example:

A company that assembles and licensed a first aid kit has now decided to also supply each of medical devices in the first aid kit individually. In such cases, each medical device supplied individually must be licensed as a single medical device

Family:

a. A medical device family IS a collection of medical devices and each medical device,

­ (i) is from same license holder;

(ii) is of same risk classification class;

(iii) has a common intended use;

(iv) has the same design and manufacturing process;

(v) has variations that are within the scope of the permissible variants.

The characteristics of a medical device may be considered as permissible variant under clause

­ (i) the physical design and material of construction of the medical device are the same or very similar;

(ii) the manufacturing processes, including sterilization method, for the medical devices are the same or very similar;

(iii) the intended purpose of medical devices is the same;

 (iv) the risk profile of the medical device, taking into account the above factors, is the same

Example:

A. Condoms that differ in colour, size and texture but are manufactured from the same material and manufacturing process and share a common intended purpose can be licensed as a Family.

B. Spherical contact lens with additional features of UV protection can be licensed as part of a Family, as this feature does not affect the basic design or manufacturing of the lens

(iv) System:

a. The medical devices comprises system , that are­

(i) from same license holder;

(ii) Intended to be used in combination to complete a common intended purpose;

 (iii) Compatible when used as system;

(iv) sold under single proprietary system name; b. The constituent component in a system which is supplied for use in more than one System, such constituent components shall be included in the application for licence for each of other System. c. If the several system fulfill the conditions, as specified in clause (b), to be grouped as Family, they may be licensed as family

Example:

A. A hip replacement system comprising of femoral and acetabular components can be licensed as system. The components must be used in combination to achieve a common intended purpose of total hip replacement. The size of component may vary.

B. A glucose monitoring System comprising of a glucose meter, test strips, control solutions and linearity solutions can be licensed as a System.

(vi) Group :

a. A medical device Group is a collection of two or more medical devices, supplied in a single package by same license holder, which are,­

(i) sold under single proprietary Group name;

(ii) a common intended purpose.

 b. The medical device in the Group may have different proprietary name and intended purpose and designed and sold by different license holder.

 c. The collection of medical devices in a Group may differ in the number and combination of products that comprises each Group, while maintaining the same proprietary Group name and Group’s intended purpose.

d. The medical device in a Group is supplied for use in another Group, such a medical device shall be included in the application of that other Group.

Example:

A first aid kit consisting of medical devices such as bandages, gauzes, drapes and thermometers, when assembled together as one package, can be licensed as a Group.


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