MEDICAL DEVICES REGISTRATION SERVICES
Permission to Conduct Clinical Investigation for “INVESTIGATIONAL” Medical Devices
Research is an ongoing subject and Science is never stagnant. Newer Medical Devices are being researched and developed worldwide to be Launched for better health of global consumers. In cases where a medical device is being developed and never been approved by any regulatory authority in the world, the medical device or pharmaceutical companies working on developing such medical devices need to conduct various tests and investigate the possible outcomes of such tests.
Therefore, in order to Check the Safety ,Efficacy & Performance of such Devices , Medical device companies need to seek prior permission from CDSCO to conduct Clinical investigation of such investigational medical devices.
An application to Conduct Clinical Investigation for “INVESTIGATIONAL” Medical Devices Is required to be submitted to CDSCO on SUGAM Portal.
Application Form :
The new Medical Device Rules 2017, have categorised the notified categories of medical devices into 4 broad categories based on the risk classification of respective products. In order to seek Conduct Clinical Investigation for “INVESTIGATIONAL” Medical Devices it is important to note the categorisation and correct forms so that we can ascertain the correct fee structure applicable for the grant of approval. The below table suggests that application form , approval form, fee structure based on the risk class of products
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Application Form |
Approval Form |
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MD 22- Application for Grant of permission to conduct clinical investigation of an investigational medical device |
Form 23- Permission to conduct Clinical Investigation |
regulatory documents
A comprehensive checklist of documents has been issued by the regulatory authority which needs to be submitted for processing and grant of above permissions.
For a checklist of documents required for grant of Permission to Conduct Clinical Investigation for “INVESTIGATIONAL” Medical Devices, please click here.
Timelines
That’s not all!
Once, a permission in Form 23 is granted in such a case, and the national regulator is satisfied the below additional steps need to be undertaken:
Class A & Class B Medical Devices manufactured in India, manufacturers need to take further permission in Form MD 5 from the SLA. Please go through the regulatory documents and government fee for seeking permission in MD 5 from this link.
Class C & Class D Medical Devices Manufactured in India, Manufactures need to need to take further permission in Form MD 9 from the CDSCO. Please go through the regulatory documents and government fee for seeking permission in MD 9 from this link.
Class A, B, C, D Medical Devices Imported in India, Importers need to take further permission in Form MD 15 from CDSCO. Please go through the regulatory documents and government fee for seeking permission in MD 15 from this link.
Preparing regulatory documents is a time consuming and meticulous exercise. As an importer or overseas manufacturer , one is already engrossed in various business aspects prior to placing the product in India. If a mistake is made, it can lead to complete delay in regulatory gaps, business plan, overheads, financial planning issues as well as supply chain disruption.
WHY NKG FOR Medical Device Regulatory Services
NKG has a Dedicated and Efficient team of experienced regulatory professionals who can help you Plan your regulatory needs and smoothen the process for Regulatory approvals. Strategically located in New Delhi, the “regulatory “ capital of India, NKG makes a head start by providing clear and easily understandable requirements
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NKG has a Dedicated and Efficient team of experienced regulatory professionals who have Registered more than 2000 brands until now who can help you Plan your regulatory needs and smoothen the process for Regulatory approvals. Strategically located in New Delhi, the “regulatory “ capital of India, NKG makes a head start by following its unique time tested “Step-by- Step “ process that puts a lot of method in between the madness.
