May-June 2019

Updates on Medical Device Regulations in India & Key Features Of Roadmap Ahead

• New online system for Medical devices is functional for the registration of Notified Bodies. Six notified bodies have been registered and information is available on the CDSCO website. Grouping of Medical Devices and IVDs along with essential principle checklist has been finalized in consultation with the stakeholders and uploaded in the CDSCO website.

• Notification of Medical Device Officer and Medical Device Testing Laboratories have been published.

• CDSCO organised workshops to impart trainings various stakeholders including State Licensing Authorities for the effective implementation of Medical Devices Rules, 2017.

• For addressing various questions on regulatory practices in medical devices, Frequently Asked Questions (FAQ) on medical devices and in vitro diagnostics is uploaded on CDSCO website. Also regular interactions are taking place with all the stakeholders to resolve their regulatory practices issues.

• Guidance on Performance Evaluation of In-vitro Diagnostic Medical Devices have been published on the website.

• Guidance document for stability study and post marketing surveillance of In Vitro Diagnostics is prepared and shared with the stakeholders for their comments.

• Setting up of Public Relation Office at CDSCO (HQ), New Delhi will act as single window to guide, assist and providing information to the innovators regarding regulatory requirements. Function from 10:00 am to 5.30pm in all working days.

• Launch of Support Cells for WHO PQS for IVDs in India for providing guidance to the Indian manufacturers for the WHO Prequalification of In Vitro Diagnostics Programme in India

1) National Institute of Biologicals in North India

Materio-vigilance Programme

• Materiovigilance programme of India was launched on 6th July 2015 at Indian Pharmacopoeia Commission, Ghaziabad.

• Indian Pharmacopoeia Commission functions as National Coordination Centre (NCC).

• Sree Chitra Tirunal Institute for Medical Sciences & Technology (SCTIMST), Thiruvananthapuram act as National Collaborating Centre.

• National Health System Resource Centre (NHSRC), New Delhi, act as Technical support partner

• Central Drugs Standards Control Organisation (CDSCO), New Delhi, support MvPI with experience of functioning as National regulator.

Initiative taken by NIB, Noida

NIB, Noida also evaluate the following IVDs

• Syphilis test kit

• Blood glucose test strips

• Dengue IgM ELISA

• Chikungunya IgM ELISA

• Blood grouping sera

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