In India, In -Vitro Diagnostic kits/reagents are regulated under the provisions of the Medical Device Rules, 2017.
IVD’s are defined as substances intended to be used outside human or animal bodies for the diagnosis of any disease or disorder in human beings or animals covered under sub-clause (i) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 and IVDs that are notified, from time to time, as a device under sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940.
- IVD products which are currently registered in India have to be registered according to the provisions of Medical Device Rules 2017.
- Instruments, equipment and software used with IVDs are not be covered in Medical Device Rules 2017.
- Since IVD’s are interventional and put into systemic circulation in living bodies, all principles and norms applicable for regulations of chemical, biological and radiological drugs shall also be applicable in such products.
- In – Vitro Diagnostic devices for HBsAg, HIV and HCV manufactured / Imported under valid license issued by the CLA or SLA, may also be used in Blood Bank, as the criteria like Sensitivity (%) and Specificity (%) for evaluation of the HBsAg, HIV and HCV diagnostic kits for the Transfusion purpose (Blood Banks) and Diagnostic purpose are same, Provided the manufacturer claims in the product labels or in the IFU that the product is intended both the purposes; for blood screening and diagnostic.
- Both shelf life or expiry date and date of manufacture shall require on the labels.
Central Licensing Authority: Enforcement of rules in matters related to:
- Import of all Classes of IVDs.
- Manufacture of Class C and Class D IVDs.
- Clinical performance evaluation and approval of new in vitro diagnostic.
- Registration of Notified Bodies
- Registration of Laboratories for carrying out test or evaluation.
- Test licences for manufacture or import for all class of IVD
State Licensing Authority: Enforcement of rules in matters related to:
- Manufacture for sale or distribution of Class A or Class B IVD
- Sale, stock, exhibit or offer for sale or distribution of IVDs of all classes.
Classification of IVD:
(i) low risk – Class A;
(ii) low moderate risk- Class B;
(iii) moderate high risk- Class C;
(iv) high risk- Class D.
