Diagnostic Kit – For Manufacturers

Diagnostic Kit – For Manufacturers

In Vitro Diagnostic Kits/reagents are 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 In Vitro Diagnostic Kit/ reagents 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.

In Vitro Diagnostic Kit/ reagents are regulated in India under the provisions of Drugs & Cosmetics Act, 1940 and Rules 1945. Earlier there were no separate guidelines for the registration of the In Vitro Diagnostic Kits/reagents in India. However, the Government of India in the year 2017 published an official notification for the medical device and In Vitro Diagnostic Kit registration in India. The New rules has classified 462 products as Medical Devices and 250 products as IVD.

Following In Vitro Diagnostic Kits/reagents are notified under Drugs & Cosmetic Act 1940.

• In-Vitro Diagnostic Devices for HIV
• In-Vitro Diagnostic Devices for HBV
• In-Vitro Diagnostic Devices for HCV
• In-Vitro Blood Grouping Sera

All In-Vitro Diagnostic Kits and Reagents excluding those listed under Notified category would be covered under the category of non- notified In- Vitro Diagnostic products.

Permission to Manufacture or Permission for loan license to manufacture Class A & B Diagnostic kits in India from State FDA (Form MD-5 and Form MD-6)

The application for obtaining Manufacturing License for the intended In- Vitro Diagnostic Kits and reagents in Class A & B is filed in Form MD-3 and the application for obtaining loan licence is filed in Form MD-4 along with prescribed fees. Subsequently, the Manufacturing License for Class A& B IVD is obtained in Form MD- 5 and the Loan License is obtained in Form MD-6.

We at CliniExperts provide end-to-end solution to the manufacturers and marketers in India for obtaining the swift license/Certifications by filing the unambiguous dossiers.
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Permission to Manufacture or Permission for Loan License to Manufacture Class C & D Diagnostic Kits in India from CDSCO (Form MD-9, Form MD-10)

The application for obtaining Manufacturing License for the intended In- Vitro Diagnostic Kits and reagents in Class C & D is filed in Form MD-7 and the application for obtaining loan licence is filed in Form MD-8. The permission to manufacture In- Vitro Diagnostic Kits and reagents for sale and distribution of Class C & Class D In- Vitro Diagnostic Kits and reagents is obtained in Form MD-9 and the permission to obtain loan license to manufacture In- Vitro Diagnostic Kits and reagents for sale and distribution of Class A & Class B In- Vitro Diagnostic Kits and reagents is obtained in Form MD-10.

We at CliniExperts provide end-to-end solution to the manufacturers and marketers in India for obtaining the swift license/Certifications by filing the unambiguous dossiers.
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Permission for Test License to Manufacture Diagnostic Kits and Reagents (Form MD-12, Form MD-13)

Test license is a license issued by the authority, to a manufacturing firm stating the authority to manufacture In Vitro diagnostic kits and reagents for test and evaluation with a purpose of statement of “Not for sale or Commercial Use”.
A licence granted remains valid unless cancelled earlier or remain in force for a period of three years from the date of its issuance.

We at CliniExperts provide end-to-end regulatory solution to the manufacturers for all the Diagnostic kits related activity for hassle free production and marketing in India.
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