This circular, No. IVDClarification24719, issued by the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Ministry of Health & Family Welfare, on October 11, 2019, provides further guidance regarding the external performance evaluation (PER) of In Vitro Diagnostics (IVDs) under the Medical Device Rules (MDR). Specifically, for the purpose of granting Import/Manufacturing licenses, the State Licensing Authority/Central Licensing Authority (SLA/CLA) may require a Performance Evaluation Report from an external lab for three batches of IVDs intended for the detection of: HIV, HBV, HCV, Blood Grouping reagent, Cancer, Tuberculosis, Malaria, Dengue, Chikungunya, Syphilis, Typhoid, Influenza, TORCH (Toxoplasma gondii, Rubella virus, Cytomegalovirus, Herpes simplex virus), Chlamydia, Pneumonia, Methicillin-Resistant Staphylococcus Aureus, Enterovirus, markers for congenital disorders (e.g., Down's Syndrome screening), and sexually transmitted agents (Treponema pallidum, Neisseria gonorrhoeae, Human Papilloma Virus, Herpes Virus), and other life-threatening infectious agents.
For IVDs in categories 13 to 20 (TORCH, Chlamydia, Pneumonia, MRSA, Enterovirus, congenital disorder markers and STIs) that have been licensed and available in the Indian market for an extended period and are manufactured in fewer batches annually, the SLA/CLA may initially accept a PER from an external lab for only one batch for licensing purposes. However, the manufacturer must submit satisfactory PERs for the subsequent two consecutive batches to the concerned authority as they are manufactured.
The circular clarifies that external lab performance evaluations can be conducted at locations compliant with established rules. While testing is generally expected to occur at laboratories indicated in the PER guidance document, alternative testing options are available, including Central Government or State Government laboratories of any hospital or institute laboratories accredited by NABL or hospitals accredited by NABH, as provided in the Medical Device Rules, in cases of laboratory unavailability, extended testing times, or other problems.
The circular was issued by Dr. V. G. Somani, Drugs Controller General of India. The issuing organization is the Diagnostic Division, FDA Bhawan, Kotla Road, New Delhi-110002.
Key Entities Referenced
Central Drugs Standard Control Organisation: A national regulatory body for pharmaceuticals and medical devices in India.
Ministry of Health Family Welfare: The Indian government ministry responsible for public health.
Medical Device Rules: Indian regulations governing the manufacturing, import, sale, and distribution of medical devices.
HIV: Human Immunodeficiency Virus, a retrovirus that causes AIDS.
HBV: Hepatitis B Virus, a viral infection that attacks the liver.
HCV: Hepatitis C Virus, a viral infection that causes liver inflammation.
Drugs Controller General India: Head of the Central Drugs Standard Control Organization, responsible for drug regulation in India.
New Delhi, Delhi: The location of the Central Drugs Standard Control Organisation's office.
No. IVD/Clarification/247/19
Government of India
Central Drugs Standard Control Organisation
Directorate General of Health Services
Ministry of Health & Family Welfare
(Diagnostic Division)
FDA Bhawan, Kotla Road,
New Delhi-110002,
Dated:- 11.10.2019
Circular
Subject: External Performance evaluation of I\VD's under MDR -— further guidance
With reference to subject cited above, it is clarified that as per the Guidance on
Performance Evaluation, SLA / CLA may require the Performance Evaluation Report
from the external lab for three batches for the purpose of grant of Import/ Manufacturing
license only for the following In-vitro Diagnostics;
In-vitro Diagnostic Medical Devices intended for:- 1. HIV, 2. HBV, 3. HCV, 4. Blood
Grouping reagent, 5. Cancer, 6. Tuberculosis, 7. Malaria, 8. Dengue, 9. Chikungunia, 10.
Syphlis, 11. Typhoid, 12. Influenza, 13. TORCH (Toxoplasma gondii, Rubella virus,
Cytomegalovirus, Herpes simplex virus) 14. Chlamydia 15. Pneumonia, 16. Methioilline-
Resistant Staphylococcus Aureus, 17. Entero virus. 18. Marker for congenital disorder
e.g. Screen test for Down's Syndrome 19. Sexually transmitted agent i.e. Treponema
pallidurn, Neisseria gonorrhoeae, Human Paoliloma Virus, Herpes Virus 20. Other life
threatening Infections / agent.
In case of In-vitro Diagnostics mentioned at s.no 13 to 20 which are licensed and
available in the Indian market for long time and manufactured in lesser number of
batches per year, SLA / CLA may initially require the Performance Evaluation Report
from the external lab for one batch for the purpose of grant of license, however, the
subsequent two consecutive batches satisfactory PER shall be submitted by the
manufacturer to the concerned authority as an when it is manufactured.
Further, with respect to the question that, where performance evaluation by External lab
can be carried out for the consideration of grant of license for |VDs specified above, it is
to clarify that it may be carried out at place as per the rule and it is generally expected
that testing is performed at laboratory indicated in the guidance document on PER and
lf there is any problems including inability of lab or longer testing time etc., other options
for testing like any Central Government or State Government Laboratory of any hospital
or of any institute laboratory accredited by NABL or by any hospital accredited by NABH
are also available as provided in the Medical Device Rules.
VA
Dr. V. G. Somani
Drugs Controller General (India)