Consultation on Medical Device and Diagnostic Kit for India Market

Presently, the Indian market for medical devices is largely unregulated. Medical devices are freely imported into India. Only certain products require medical device registration in India. Over the years, there have been three announcements outlining the medical device products that must be registered.

Prior to 2005, medical devices such as disposable hypodermic syringes, tubal rings, condoms, metered dose inhalers, etc., were required to be registered in India. Beginning 1 March 2006, items such as cardiac stents, drug eluting stents, catheters, intraocular lenses and bone cement, were required to be registered for import, manufacture and sale. And on 20 March 2009, the Central Drugs Standard Control Organization (CDSCO) clarified that sterile medical devices such as spinal needles, insulin syringes, endotracheal tubes, cardiac patches, and extension tubes were also required to be registered. In the future, due to the huge market opportunity in India, more and more foreign medical device companies are expected to try to import their products. With an evolving situation on regulation and medical device registration in India, companies will need to stay up-to-date in order to achieve success in India.

The CliniExperts Differentiators

• Medical device & Diagnostic kit regulation is still not properly defined in Indian regulation, hence understanding the product and executing the projects accordingly is a huge challenge . We at CliniExperts develop proper regulatory strategy and share it with our clients, which help build support for the strategy and ensure that CliniExperts held to its promise of executing the projects.
• Our regulatory services team perform scientific reviews of the dossier content, and guides the team to prepare a dossier that avoids ambiguity or query.
• We do robust follow ups after submission of dossier at CDSCO.
• We can represent sponsors on their behalf and can attend MDAC meeting organized by CDSCO. We have already attended numerous MDAC meetings, this enables us to understand the expectation of Clinicians/Experts during MDAC meeting. Our enriched experience ensure that our clients know and understand the expectation of Experts/Clinician.
• We provide services to our clients for performance evaluation of test sample of diagnostic kits from NIB (National Institute of Biologicals, Noida).

We at CliniExperts have already obtained numerous approvals and licenses for medical devices and diagnostic kits for our clients. We provide following services to our clients.

1. Import and Registration of Medical Devices

Application for Registration Certificate in respect of the premises and the devices manufactured by the manufacturer and meant for import into India is required to be made by the manufacturer or importer or his agent in India, at the CDSCO, New Delhi.

CDSCO has listed few medical devices under notified category of medical devices. Only Notified Medical Devices required to be registered at CDSCO, New Delhi.

We at CliniExperts can obtain Registration Certificate and subsequently Import License for our clients.

2. Registration Certificate of Critical / Notified Diagnostic Kits

Diagnostic Kits falling under Critical and Notified category must be registered at CDSCO, New Delhi before importing it into India. We at CliniExperts can register Notified / Critical Diagnostic Kits at CDSCO, New Delhi for our clients.

3. Test licence for Medical Device and Diagnostic Kits

We can obtain Test License for our client for testing and analysis of samples at NIB, Noida. We have assisted many clients in the analysis of testing sample at NIB, Noida.

4. Import License for Diagnostic Kits

Diagnostic Kits falling under Non-Notified category don’t require to be registered at CDSCO, New Delhi. These category of kits can be imported after obtaining import license. We can obtain Import license for both Notified and Non-Notified category of diagnostic kits.

5. Manufacturing Licence for Medical Device.

Application for the grant of licence for manufacture of notified Devices shall be made to the State Licensing Authority, accompanied by the requisite fee in the Form and manner as prescribed in the said Rules along with a copy to the office of DCG(I).

We can obtain manufacturing license for our clients. We have presence in almost all states of India and this enable us to effectively liaison with state FDA.

6. Clinical Trial Approval for Medical Devices and Diagnostic Kits

We obtain approval for both Global Clinical Trial and Local Clinical Trial for overseas sponsors or local device manufacturing companies.