Ministry of Health and Family Welfare issues Grouping Guidelines for Medical Devices Applications

Mar 22, 2018 | by Avantis RegTech Legal Research Team

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Ministry of Health and Family Welfare vide notice dated March 16, 2018 has issued grouping guidelines for Medical Devices applications. These guidelines are issued in respect of grouping of Medical Devices for a person who applies for licence to import or manufacture for sale or distribution of medical devices.

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. 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-

(i)       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. It may be sold in a range of package sizes.

(ii)     Family: - 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.

(iii)   In vitro diagnostics 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;

(iv)   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.

[File NoX.11035/49/2018-DR]



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