The Central Drugs Standard Control Organization (CDSCO) is a National Regulatory Authority operating under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India. Medical devices are freely imported into India. To ensure the quality of the product being imported into the country Government of India has developed regulations and guidelines. The guidelines are applicable when one wants to import medical devices from outside India. The devices are classified as per the CDSCO guideline. There is a list of CDSCO notified devices and has provided a complete procedure for import of medical devices in-country.
Medical devices entering into Indian Market must be in compliance with guidelines set forth by the CDSCO. CDSCO is solely responsible for all clinical and new drug trials in India as an import license is to import medical device from another country, so overseas company and Indian company both needs to submit a document for Medical Device and manufacturing unit.
All medical devices imported into India CDSCO Medical Device Import License required. If any medical devices are imported into India without getting Registration, it will be considered a violation of Indian law and thereby invite penalty for same.
There was an amendment in Medical Device Rule 2017 in February 2020 referred to as “Medical Devices (Amendment) Rules 2020. As per the amendment, all the medical devices imported to India before October 2021 require Registration. For the Registration, importers of Medical device or equipment has to register themselves with the Central Standard Control Organization (CDSCO)
Application as per CDSCO guidelines
- An Authorized agent having a valid license to manufacture for sale or distribution or wholesale License for same can apply for an application for grant of import License for Medical Device to the central licensing authority online in form MD14 on the portal of Ministry of Health and Family Welfare for obtaining a license.
- If the central Licensing authority has a reason to believe that the quality of the medical device has been compromised, then it is subjected to go through the test & evaluation in the testing laboratory as specified by the Central Licensing Authority.
- After evaluation of the application form and documents, if the central licensing authority is satisfied, it will grant a License to import in form MD 15. If the authority is not satisfied, it may reject the application, and the reason for rejection is required to be recorded in writing within nine months from the date of application.
- If the application is rejected, an applicant can make an appeal to the Central Government within forty-five days from the date of rejection and the Government, after an enquiry in this matter, pass an order in relation there within ninety days from the date of appeal.
Whether Components and accessories imported also require Registration as per CDSCO Guidelines?
As per CDSCO, components and accessories imported need not be registered separately. However, what separately means is not clear. All components and accessories should be registered because, in the registration form, details of components and accessories are required to be filled if any components and accessories are not registered as Medical Device for some reason, then they need to be registered as ‘Medical Device’ as per the definition of Medical Device mentioned in the Act.
Documents required for Registration are AN ISO 13485 certificate, a certificate to Foreign Government or Free Sale Certificate and an undertaking stating that the information and documents submitted are true to their knowledge and are authentic.
Consequences of Non-Registration as Per CDSCO Guidelines
A device which is required to be registered cannot be imported into India without Registration after October 1, 2021. The importers need to get Registration done before they import medical devices to India.
Devices imported after October 1, 2021, if not registered, will invite penal action under The Drugs and Cosmetics Act, 1940.
Test license for import
Test License is for the import of a small amount of drug or small quantity of medical device, which is prohibited under section 10 of the Drugs and Cosmetics Act and Rules 1945, for the purpose of examination, evaluation or analysis.
For the import of new drugs for testing or clinical trials, form 11 is required to be filled.
Procedure for obtaining Form 11 as per CDSCO guidelines for Medical Device import
An application is required to be made in Form 12 for obtaining a License under Form 11. Since 1st April 2016, all applications should be made through the CDSCO’s SUGAM portal.
Following are the condition which the applicant must consider as per Rule 33 of the Drugs and Cosmetics Act[1],
- No drug should be imported for commercial use
- Substances imported for evaluation must be that substance only for which a license is to be granted.
- The premises used for evaluation must be made available for inspection with or without notice by licensing authority authorized by the Central licensing authority.
Documents required
- Covering Letter
- Form 12
- TR6 Challan utilization
- Testing protocol
- Product labels and brochures
- FSC ( Free Sale Certificate ) in the country of origin
- Legal agreement
- Approval by Ethics committee
Duration of License granted
A license is valid for five years from the date of its issue.
Renewal of License
Applicant needs to apply for renewal of License in Form 11 with all important documents and challan. The Renewal of License is not available for Test License.
Conclusion
Ever since the increasing demand for import and export of medical device from India, Government has been coming up with new policies to make such process easy and smooth. The Registration for import of Medical devices is mandatory to process, and it must strictly be as per Central Drugs standard control organization.
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