The Ministry of Health and Family Welfare (Department of Health and Family Welfare) (“Ministry”) has recently notified the Grouping Guidelines for Medical Devices Applications (“Guidelines”),

In the Guidelines, the Ministry has segregated different categories of medical devices into certain groups for ease of use by persons who are applying for a license to import or manufacture for sale or distribution of medical devices. An applicant may group the medical devices having same or similar intended uses or commonality of technology and submit a single application for the same.

The Ministry has set out six different groups of medical devices as given below:

1. Single:

A single medical device is a medical device sold as a distinct packaged entity and does not meet the criteria for family, IVD test kit, system, IVD cluster or a group including ones sold in a range of package sizes.

2. Family:

            A medical device family is a collection of medical devices where 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.

3. In VitroDiagnostics Cluster:

An in-vitro diagnostics cluster comprises of a number of in-vitro diagnostics reagents or article which are,

(i)            from same license holder;

(ii)           of a common methodology;

(iii)          sold under single proprietary name; and

(iv)          compatible when used as a Test Kit.

4. System:

The medical devices comprise a 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; and

(iv)          sold under single proprietary system name;

5. In VitroDiagnostics Test kit:

An in-vitro diagnostics kit is a device that consists of reagents or articles which are:

(i)            from same license holder;

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

(iii)          sold under single proprietary Test Kit name; and

(iv)          compatible when used as a Test Kit;

6. Group:

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; and

(ii)           a common intended purpose.

For a detailed read, please click on the hyperlink below.

Source: Ministry of Health and Family Welfare

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