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 NameDescriptionCertificate ObtainedApplication formRelevant RuleLicensing
Authority
Timeline
Registration Certificate for Medical DeviceThis 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 yearsForm 41Form 40Rule 24-ADCGI9 months
Import LicenseOnce 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 countryForm 10Form 8Rule 24DCGINo time period
prescribed (Usually
within 3 months)
Test License for ImportForm 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 activityForm 11Form 12Rule 33DCGINo time period
prescribed
Test License for ManufacturingForm 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 29Form 30Rule 89DCGINo time period
prescribed (usually
between three to
six months)
Clinical Trial PermissionAn 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 formatForm 44Rule 122-DADCGINo time period
prescribed
Permission to Market Post Successful clinical TrialA 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 45Form 44Rule 122-ADCGIsix months
Permission to Manufacture Post Successful Clinical TrialA 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 46Form 44Rule 122-BDCGIsix 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 personForm 20, Form
21(for sutures,
ligatures, In-vitro
diagnostic devices)
Form 19Rule 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 19Rule 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 CDSCOForm 28Form 27Rule 76For 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 CDSCOForm 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)