As I stated yesterday, Mundipharma look the hot favourite to get Viraleze approval expedited in India .... the link below outlines the processes for all classifications of medical devices but I have pulled this particular section up - it clearly states as Step 1 to “Appoint a local agent in India to be the applicant and license holder”
Mundipharma have made several regulatory submissions for Betafem Vivagel with the SPL7013 component so I would say they could easily review and modify the EU submission to make it suitable for submission in India, put their stamp on it as the ‘local license holder’ and obtain a priority review given the products relevance to the current dire situation of COVID-19 .... IMO expect a license deal with Mundipharma to be announced soon
https://www.pacificbridgemedical.com/regulatory-services/medical-device/product-registration/india/
Summary of Steps for the Medical Device Registration Process in India
- Appoint a local agent in India to be the applicant and license holder
- Prepare Device Master File (DMF)
- Prepare Plant Master File (PMF)
- Prepare application Form w/supporting documents
- Submit above documents to DCGI with fees
- DCGI reviews and sends back an inquiry letter
- Applicant responds and addresses inquiries made by the DCGI
- DCGI may request technical presentation
- Approval
Ann: Shareholder Newsletter, page-33
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