FREQUENTLY ASKED QUESTIONS
Fast and Reliable Medical Device Regulatory
FAQ'S - MEDICAL DEVICES
15. What is the validity of "Test License" in Form-11?
Answer. A Test License unless, it is sooner suspended or cancelled, shall be valid for a period of three year from the date of its issue.
16. Whether Registration Certificate and Import Licence are required to import Components of Medical Devices?
Answer. Yes, Devices in assembled form ready for packaging and sterilization are regulated under the provision of Drugs and Cosmetic Act 1940 and Rules there under. Hence Registration Certificate and Import Licence are required to import into India.
17. Whether both legal (If any) and actual manufactures name and address should be stated in the Free Sale Certificate issued by the national Regulatory agency for the purpose of registration of devices in India?
18. Any changes in name and/or address of Indian agent/ Importer or change in constitution after issue of Registration Certificate/ Import Licence are required to be communicated to the Licensing Authority?
Answer. Yes, Indian agent/ Importer shall inform the licensing authority immediately in writing and shall submit fresh application as per Rules.
19. Any changes in name and/or address of legal and/or actual manufacturer or change in constitution after issue of Registration Certificate/ Import Licence are required to be communicated to the Licensing Authority?
Answer. Yes, the manufacturer or his authorized agent in India shall inform the licensing authority immediately in writing in the event of any change in the constitution of the firm and / or address of the registered office / factory premises operating under this Registration Certificate. Where any such change in the constitution of the firm and/or address takes place, the current Registration Certificate shall be deemed to be valid for a maximum period of three months from the date on which the change has taken place unless, in the meantime, a fresh Registration Certificate has been taken from the licensing authority in the name of the firm with the changed constitution of the firm and/or changed address of the registered office or factory premises.
20. Whether acquisition/merger of one company by another company is considered as change in constitution of the company?
21. What are the changes which do not require fresh registration and only notification or amendment may be obtained?
Answer. Change in shelf life, change in the method of testing, minor change in manufacturing process not affecting the final product specifications, updation in IFU like warnings, precautions, additional instructions and safety etc., labels and packaging (provided proper justification should be provided for the above changes).
22. If there is a change in the Indications and/ or Intended use of a registered notified medical device, does the applicant need to submit a fresh application including Power of Attorney incorporating the changed Indications and/ or Intended use of the registered notified medical device?
Answer. Yes, revised Power of Attorney Schedule D (I), D (II), IFU etc is required to be submitted, reflecting the changes/modification to indications.
23. What is the procedure for adding/ modifying/altering the currently registered Indications for the Medical Devices?
Answer. The process is to file a change notification to CDSCO and this is followed by approval from CDSCO. Revised Power of Attorney, Schedule D (I), D (II) and IFU etc with updated indication will be required to be submitted to CDSCO.
- MEDICA13-16 Nov 2017, Germany
- IOACON 26-31 Dec 2017, Indore (India)
- NSICON 30-Nov-3rd Dec 2017, Nagpur (India)
- Arab Health 29th Jan-1st Feb 2018, Dubai