As you are already aware, the Medical Devices (Amendment) Rules, 2018 [MDR 2017], are effective from August 1, 2018. Further to the Rules the Central Drugs Standard Control Organization (CDSCO) has issued guidelines on Performance Evaluation of In-vitro Diagnostic Medical Devices.
Relying on the amended Clause (h), Paragraph (ii), Part II of Fourth Schedule of the MDR 2017, the CDSCO has listed down the In-vitro Diagnostics ( given below) for which the Performance Evaluation Report may be required by the State Licensing Authority or Central Licensing Authority.
In-vitro Diagnostic Medical Devices intended for-
- HIV
- HBV
- HCV
- Blood Grouping reagent
- Blood glucose test reagent
- Cancer
- Tuberculosis
- Malaria
- Dengue
- Chikungunia
- Syphlis
- Typhoid
- Influenza
- ToRCH
- Chlamydia
- Pneumonia
- Methicilline-Resistant Staphylococcus Aureus
- Entero virus
- Marker for congenital disorder e.g. Screen test for Down’s Syndrome
- Sexually transmitted agent i.e. Treponema pallidum, Neisseria gonorrhoeae, Human Papilloma Virus, Herpes Virus
- Other life-threatening Infections / agent.
The guidelines provide a category – wise list of names of laboratories and testing facilities that are to be considered for conducting Performance Evaluation of In-Vitro Diagnostics. In case the listed Laboratories are unable to conduct the Performance Evaluation, such evaluation may be done at any laboratory accredited by the National Accreditation Board for Testing and Calibration Laboratories or any hospital accredited, by National Accreditation Board for Hospitals and Healthcare Providers and other facilities as specified in the MDR 2017.
Source: Central Drugs Standard Control Organisation
