Med Dev India Registration

ttylda

Starting to get Involved
Welcome Everyone,

I work at company, which is preparing to registare its Class C medical device in India. I would like to ask few questions:

1) The company is still under MDD certificate (the MDR certification will be next year) - will it be valid certificate for Indian Authorities ??
2) If company does not have sterile devices and there is no clean room or "white production", whould it need any sanitation protocols (Appendix I, sub. 5.)??
3) Would it be enough to prepare the company's organisation chart and briefly presciption of a key personnel (Appendix I, sub. 2)??
4) For the Appendix II, can I prepare a folder with documents, which have all needed information and prepare an additional document, which sums up all documents in the folder??
5) I have check the databank of CDSCO with registered devices and I couldn't find any similar device. What should I do in such situation (Appendix II, sub. 1.5.)??
6) Does Design Certification/Design Examination Certificate can refer to EN ISO 13485:2016 certificate (Appendix II, sub 1.6.??
7) Should I add a whole IFU for the Labelling part (Appendix II, sub. 3.) or only a part, where labelling is presented ??
8) Can a risk management be prepared on the basis of EN ISO 14971:2012?? The company is during implementation of EN ISO 14971:2019??

Thank you in advance.

Ttylda
 
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