Notified medical devices are regulated by the Central and State Government of India. It is important to have knowledge of the important forms and documents required to commercialize your medical device in India. The required licenses and permissions are explained in the table below: whether they are governed by the CDSCO or a state authority. Contact us at Morulaa to learn more.
Licenses and Forms
License Name | Description | Certificate Obtained | Application form | Relevant Rule | Licensing Authority | Timeline |
---|---|---|---|---|---|---|
Registration Certificate for Medical Device | This is to obtain product approval for Indian market entry. If your products come under the notified device category then they would have to registered with the CDSCO under form 40. The registration certifcate is valid for 3 years | Form 41 | Form 40 | Rule 24-A | DCGI | 9 months |
Import License | Once the foreign manufacturer obtains the registration certificate in Form 41, the distributor needs to apply for Import license in form 8. This license allows the distributor to clear customs and import the product into the country | Form 10 | Form 8 | Rule 24 | DCGI | No time period prescribed (Usually within 3 months) |
Test License for Import | Form 11 is granted for the import of small quantities of drugs and medical devices for the purposes of examination testing or analysis. Products imported under form 11 will used for testing and analysis purpose only and not for any commercial activity | Form 11 | Form 12 | Rule 33 | DCGI | No time period prescribed |
Test License for Manufacturing | Form 29 is a licence to manufacture drugs for the purpose of Examination Testing and Analysis. The application is made in Form 30 and the certificate is valid for 1 year. The applicant cannot perform any manufacturing activity other than for examination, testing and analysis purpose in the proposed manufacturing site. | Form 29 | Form 30 | Rule 89 | DCGI | No time period prescribed (usually between three to six months) |
Clinical Trial Permission | An application for grant of permission to conduct, - human clinical trials (Phase-I) - exploratory clinical trials (Phase-II) on completing phase I trials - confirmatory clinical trials (Phase-III) on completing phase II and phase I | No specified format | Form 44 | Rule 122-DA | DCGI | No time period prescribed |
Permission to Market Post Successful clinical Trial | A license in form 45 is granted when an application is made in Form 44 under the rule 122-A, to allow import of medical devices which are new in the Indian market without conducting clinical trials. The applicant must provide satisfactory post market data, clincal studies conducted worldwide and safety data to obtain the registration certicate for India. | Form 45 | Form 44 | Rule 122-A | DCGI | six months |
Permission to Manufacture Post Successful Clinical Trial | A license in form 46 is granted when an application is made in Form 44 under the rule 122-B, to allow manufacturing for sale of medical devices which are new in the Indian market without conducting clinical trials. | Form 46 | Form 44 | Rule 122-B | DCGI | six months |
Retail sale of Notified Medical Devices | Application for grant or renewal of a restricted licence to sell, stock or exhibit or offer for sale, or distribute drugs by retail by dealers who do not engage the service of a qualified person | Form 20, Form 21(for sutures, ligatures, In-vitro diagnostic devices) | Form 19 | Rule 61(1), Rule 61(2) (for sutures, ligatures, In-vitro diagnostic devices) | State Drug Licensing Authority | No time period prescribed (usually between three to six months) |
Whole sale of Notified Medical Devices | Application for grant or renewal of a licence to sell, stock, exhibit or offer for sale, or distribute drugs other than those specified in Schedule X who engage the service of a qualified person. | Form 20-B, Form 21-B (for sutures, ligatures, In-vitro diagnostic devices) | Form 19 | Rule 61(1), Rule 61(2) (for sutures, ligatures, In-vitro diagnostic devices) | State Drug Licensing Authority | No time period prescribed (usually between three to six months) |
License to manufacture Notified Medical Devices | Manufacturing of notified medical devices (Under CLAA Scheme) for sale in India is given in Form-28 with an application made in form 27. This license is granted by the State Authority for manufacturing of Disposable Hypodermic Syringes, Disposable Hypodermic Needles, Disposable Perfusion sets and In- vitro Diagnostic Devices while the other notified devices come under the CDSCO | Form 28 | Form 27 | Rule 76 | For certain specified Notified Medical Devices – the DCGI. For other Notified Medical Devices – the State Drug Licensing Authority. | No time period prescribed (usually between three to six months) |
Loan License (manufacture in facility owned by third party) | Manufacturing of notified device in a third party site requires a loan license in Form- 25A and Form 28-A. This license is granted by the State Authority for manufacturing of Disposable Hypodermic Syringes, Disposable Hypodermic Needles, Disposable Perfusion sets and In- vitro Diagnostic Devices while the other notified devices come under the CDSCO | Form 25-A, Form 28-A (sutures, ligatures, In-vitro diagnostic devices) | Form 24-A, Form 27-A (sutures, ligatures, Invitro diagnostic devices) | Rule 69-A, Rule 76-A | For certain specified Notified Medical Devices – the DCGI. For other Notified Medical Devices – the State Drug Licensing Authority. | No time period prescribed (usually between three to six months) |