Risk Based Classification

Risk Based Classification

India’s In–Vitro diagnostic kit (IVD) market is expected to grow over the next several years due to increased health awareness, a growing middle class, and government health initiatives. Indian authorities overhauled the IVD and medical device regulatory process in 2017 with the publication of the Medical Device Rules, 2017. The rules came into force in January 2018 and the import, manufacturing, sale and distribution of existing In Vitro Diagnostic (IVD) kits/ reagents are regulated by the Central Drugs Standard Control Organization (CDSCO), an agency of the Ministry of Health and Family Welfare under the regulatory provisions of the Drugs & Cosmetics Act 1940 & Rules 1945.

 

In Vitro Diagnostic kits 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 subclause (i) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 and In Vitro Diagnostic Kits 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.

 

At present following notified Diagnostics Kits are regulated under the said Act & Rules.

  1. In vitro Diagnostics Devices for HIV, HBV and HCV.
  2. In vitro Diagnostics Devices for HIV, HBV and HCV (Bulk)
  3. In vitro Blood Grouping Sera
  4. In vitro Blood Grouping Sera (Bulk)

The classification provisions shall be governed by the intended purpose of the IVD’s. If the IVD is intended to be used in combination with another IVD, the classification rules shall apply separately to each of the IVD. Accessories are classified in their own right separately from the IVD with which they are used.

 

In Vitro Diagnostic Kits are classified under Chapter II, Rule 4, Sub-rule (2) of Medical Device Rules 2017 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 to moderate risk – Class B;

(iii) moderate to high risk – Class C;

(iv) high risk – Class D.

 

With a presence in India, CliniExperts can help you comply with CDSCO requirements and start selling your IVD in this emerging market.

 

 

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