FREQUENTLY ASKED QUESTIONS

FAQ'S - MEDICAL DEVICES

24. Whether any minor change which is notified to the Regulatory Authority but CDSCO’s response is awaited can be imported in India?

Answer. No

25. What is the time line for response to a change notification?

Answer. 90 working days

26. What are the Labelling rules for Medical Devices?

Answer. The Labelling of Medical Devices are to be done as per Rule 109 (A) of Drug & Cosmetics Rules. They also need to follow Rule 6 of Chapter II of Legal Metrology (Packaged Commodities) Rules 2011. The MRP is to be mentioned on each sealable pack as per NPPA order no. F No. 20 (8)/2013/Div-III/NPPA/Part-I.

27. What are mandatory addresses on the labels of registered notified medical devices being imported/ marketed in India?

Answer. The label of registered notified medical devices being imported must include the names and addresses of the legal manufacturer, actual manufacturer and the name and address of importer on which the Import License in Form 10 has been issued.

28. Can the importers of registered notified medical devices incorporate India-specific requirement on labels after/post landing in India at customs warehouse or place approved by the Licensing Authority?

Answer. Yes, importers of registered notified medical devices are currently allowed to incorporate India-specific requirements like name and address of importer, import Licence Number on imported medical devices post landing in India at customs warehouse or place approved by the CDSCO prior to release into market.

29. The Certificate of Exportability (which reflects that the proposed products may not be freely sold in the country of origin but can be exported), is acceptable as Free Sale Certificate?

Answer. No

30. Which manufacturing site is considered the manufacturing premise for the purpose of inclusion in the Form - 40?

Answer. The actual site of final batch release of the medical device is considered the manufacturing premise for the purpose of inclusion in the Form -40.

31. If applicant wants to apply for Registration Certificate but the product is not sold in the country of origin but is registered and marketed in any one of the following countries i.e. USA, Europe, Japan, Canada or Australia. Can he apply for Registration Certificate?

Answer. Yes.

32. What is the generic name of the medical device?

Answer. The generic name is the name as per the internationally accepted nomenclature for the medical devices.

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