FREQUENTLY ASKED QUESTIONS

FAQ'S - MEDICAL DEVICES

7. Whether Device manufacturing site required to be inspected before grant of Registration Certificate in Form 41? If yes, how much fees for the inspection or visit of the manufacturing premises of Medical Devices?

Answer. No, however it is mentioned in the D & C Act that a site can be inspected during the registration or after the issuance of registration. The inspection fee prescribed in the D & C Act is USD 5000, while as per GSR 78 (E) it will be increased to USD 6000 w.e.f., 1st Jan 2018.

8. What is the time period for Grant of Registration Certificate?

Answer. In case the application is complete in all respects the licensing authority shall, within nine months from the date of receipt of an application, issue such Registration Certificate in From 41.

9. What is the Duration/Validity of "Registration certificate" in Form-41 for Medical Devices in India?

Answer. A Registration Certificate, unless, it is sooner suspended or cancelled, shall be valid for a period of three years from the date of its issue. And as per GSR 78 (E) the license will be valid for 5 years.

10. When should an application for Re-Registration of devices be submitted?

Answer. Applications for Re-Registration should be submitted minimum Nine months ahead of the expiry of the registration certificate. And as per GSR 78 (E) the fee is only to be deposited as renewal.

11. Can a duplicate copy of "Registration certificate" in Form- 41 for Medical Devices in India be obtained from CDSCO?

Answer. A fee of USD 300 [or its equivalent in Indian rupees] shall be paid to obtain duplicate copy of the Registration Certificate, if the original is defaced, damaged or lost.

12. Whether Devices, having valid Import Licence, can be imported from any ports of India?

Answer. The ports as defined in Rule 43A of Drugs & Cosmetics Rules only permitted for imports.

13. Whether devices imported under valid import Licence can be stocked in any other wholesale licence premises other than stated in the Import Licence?

Answer. Yes

14. What is the Test license in Form 11?

Answer. The Test Licence in Form 11 is to import small quantities of drugs / Medical Devices/Diagnostic kits, for the purpose of examination, test or analysis provided that Imported Medical Devices under Form 11 shall not be used for any commercial purposes.

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