IVD/MD Performance Evaluation
As per CDSCO Guidelines Bio State Consulting provides IVD/MD Evaluation Performance Report (PER)
- HIV,
- HBV,
- HCV,
- Blood Grouping reagent,
- Cancer,
- Tuberculosis,
- Malaria,
- Dengue,
- Chikungunia,
- Syphlis,
- Typhoid,
- Influenza,
- ToRCH (Toxoplasma gondii, Rubella virus, Cytomegalovirus, Herpes simplex virus)
- 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.
Process:
A company which proposes to manufacture a medical device or IVD will have to register through Indian CDSCO (Govt authority body)
Our solutions in the Medical Technology space will help our clients, build strategic relationships with the Medical Technology Innovators and introduce recent technologies into the Indian Markets and mentor professionals. Facilitate in introducing robust and effective Go-to-Market (GTM) strategies and effectively monitor them to derive desired results.
Our team identifies new technology in healthcare around the globe that have the potential to meet healthcare demands in India. The Central Drugs Standard Control Organisation (CDSCO) is the regulatory body of India that provides clearances of Drugs, Medical Device, IVDs. The expertise which we offer allows manufacturers to understand the regulatory of Medical Device, IVDs Registration Certification. This along with the Selection of distributors assists manufacturers to successfully commercialise in the Indian market.