Regulation on Medical Device in India (Medical devices rules, 2017)

Ministry of health and family welfare on 31st January 2017 published the guidance regarding Medical devices.

Regulation of Medical Device

Classification of Medical devices:

Classification of medical devices.— 

(1) Medical devices other than in vitro diagnostic medical devices shall be classified on the basis of parameters specified in Part I of the First Schedule, in the following classes, namely:— 

(i) low risk – Class A; 

(ii) low moderate risk- Class B; 

(iii) moderate high risk- Class C; 

(iv) high risk- Class D.

(2) In vitro diagnostic medical devices shall be classified on the basis of parameters specified in Part II of the First Schedule, in the following classes, namely:—

(i) Low risk – Class A; 

(ii) low moderate risk- Class B; 

(iii) moderate high risk- Class C; 

(iv) high risk- Class D.

(3) The Central Licencing Authority shall, classify medical devices referred to in rule 2, based on the intended use of the device and other parameters specified in the First Schedule.

(4) Based on the classification referred to in sub-rule (3), class wise list of medical devices shall be published on the website of the Central Drugs Standard Control Organisation:

Provided that the Central Licencing Authority may, from time to time, make additions or deletions in such list of medical devices or modify the class of any medical device.

Essential principles for manufacturing medical devices.—Medical device manufacturer shall follow the essential principles of safety and performance of medical devices as may be specified in the guidelines issued by the Ministry of Health and Family Welfare in the Central Government, from time to time keeping in view the contemporary scientific and technological knowledge and development:

Provided that the guidelines to be so specified shall be in conformity with the provisions of the Act and these rules.

Product standards for medical device.— (1) The medical device shall conform to the standards laid down by the Bureau of Indian Standards established under section 3 of the Bureau of Indian Standards Act, 1985 (63 of 1985) or as may be notified by the Ministry of Health and Family Welfare in the Central Government, from time to time.

(2) Where no relevant Standard of any medical device has been laid down under sub-rule (1), such device shall conform to the standard laid down by the International Organisation for Standardisation (ISO) or the International Electro Technical Commission (IEC), or by any other pharmacopoeial standards.

(3) In case of the standards which have not been specified under sub-rule (1) and sub-rule (2), the device shall conform to the validated manufacturer’s standards.