The medical device industry plays a pivotal role in healthcare, delivering innovative solutions that improve patient care and outcomes. In India, the regulatory landscape for medical devices is governed by the Medical Device Rules 2017. These rules aim to ensure the quality, safety, and efficacy of medical devices, and the Central Drugs Standard Control Organization (CDSCO) is the key regulatory authority responsible for granting approvals and regulating medical devices.
The primary goal of CDSCO approvals is to protect patient safety. By ensuring that medical devices meet strict quality and safety standards, the CDSCO helps prevent substandard or unsafe devices from entering the Indian market.
As manufacturers, importers, and stakeholders in the medical device industry, it is essential to be aware of the different types of CDSCO approvals and the regulatory processes to meet the highest standards of compliance and deliver safe and effective medical devices to the Indian healthcare system.
CDSCO and its Role:
The CDSCO, under the Ministry of Health and Family Welfare, Government of India, plays a critical role in ensuring that medical devices available in the Indian market meet stringent quality and safety standards. It oversees the approval process for medical devices, which involves rigorous evaluation and adherence to the Medical Device Rules 2017.Types of CDSCO Approvals:
Under the Medical Device Rules 2017, CDSCO grants various types of approvals, depending on the nature and classification of the medical device. These approvals include:- Manufacturing License: Manufacturers of medical devices are required to obtain a manufacturing license to ensure that their facilities comply with the necessary quality standards. CDSCO assesses these facilities for compliance with Good Manufacturing Practices (GMP).
- Import License: Importers of medical devices into India must obtain an import license from CDSCO. This license ensures that imported devices meet the same rigorous standards as those produced within the country.
- Loan License: A loan license allows a manufacturer to use another manufacturer's premises for the production of medical devices under specific conditions. CDSCO reviews and approves these arrangements to ensure compliance with regulations.
- NOCs/Certificates: These are the exclusive approvals granted for particular objective or seeking any clarification which have not been resolved by these rules.
List of Medical Device Forms and Certificates Under Medical Device Rules 2017
| Title of the Form/Certificate | Form Number |
|---|---|
| Application for grant of loan license to manufacture for sale or for distribution of Class A or Class B medical device | Form MD-04 |
| Licence to manufacture for sale or for distribution of Class A or Class B Medical Device | Form MD-05 |
| Loan Licence to manufacture for sale or for distribution of Class A or Class B Medical Device | Form MD-06 |
| Application for grant of license to manufacture for sale or for distribution of Class C or Class D medical devices | Form MD-07 |
| Application for grant of loan license to manufacture for sale or for distribution of Class C or Class D medical device | Form MD-08 |
| Licence to manufacture for sale or for distribution of Class C or Class D Medical Device | Form MD-09 |
| Loan Licence to manufacture for sale or for distribution of Class C or Class D Medical Device | Form MD-10 |
| Form in which the audit or inspection book shall be maintained | Form MD-11 |
| Application for license to manufacture medical device for the purpose of clinical investigations, test, evaluation, examination, demonstration, or training | Form MD-12 |
| Licence to manufacture Medical Device for the purpose of clinical investigations, test, evaluation, examination, demonstration, or training | Form MD-13 |
| Application for issue of import license to import a medical device | Form MD-14 |
| Licence to import Medical Device | Form MD-15 |
| Application for a license to import medical devices for the purposes of clinical investigations or test or evaluation or demonstration or training | Form MD-16 |
| Licence to import medical devices for the purposes of clinical investigations or test or evaluation or demonstration or training | Form MD-17 |
| Application for a license to import investigational medical devices for the purposes by a government hospital or statutory medical institution for the treatment of patients | Form MD-18 |
| Licence to import investigational medical devices for the purposes by a government hospital or statutory medical institution for the treatment of patients | Form MD-19 |
| Application for permission to import a small quantity of medical devices for personal use | Form MD-20 |
| Permission to import a small quantity of medical devices for personal use | Form MD-21 |
| Application for grant of permission to conduct a clinical investigation of an Investigational Medical Device | Form MD-22 |
| Permission to conduct a clinical investigation of an Investigational Medical Device | Form MD-23 |
| Application for grant of permission to conduct a clinical performance evaluation of New In-Vitro Diagnostic Medical Device | Form MD-24 |
| Permission to conduct a clinical performance evaluation of New In-Vitro Diagnostic Medical Device | Form MD-25 |
| Application for grant of permission to import/manufacture for sale or for distribution of a medical device which does not have a predicate medical device | Form MD-26 |
| Permission to import/manufacture for sale or for distribution of a medical device which does not have a predicate medical device | Form MD-27 |
| Application for grant of permission to import or manufacture for sale or for distribution of a New In-Vitro Diagnostic Medical Device | Form MD-28 |
| Permission to import or manufacture New In-Vitro Diagnostic Medical Device | Form MD-29 |
| Memorandum to Central Medical Device Testing Laboratory | Form MD-30 |
| Certificate of Test or Evaluation by the Central Medical Device Testing Laboratory | Form MD-31 |
| Report of Test or Evaluation of Medical Devices by Medical Device Testing Officer | Form MD-32 |
| Application from a purchaser for test or evaluation of a medical device under section 26 of the Drugs and Cosmetics Act, 1940 (23 of1940) | Form MD-33 |
| Order under clause (c) of subsection (1) of section of the Drugs & Cosmetics Act, 1940, (23 of 1940) requiring a person not to dispose of stock in his possession | Form MD-34 |
| Receipt of stock of medical devices for record, register, document or material object seized under clause (c) or clause (cc) of sub-section (1) of Section 22 of the Drugs and Cosmetics Act (23 of 1940) | Form MD-35 |
| Intimation of person from whom sample is taken | Form MD-36 |
| Receipt for Sample of medical device(s) taken where fair price tendered thereof under sub-section (1) of Section 23 of the Drugs and Cosmetics Act, 1940 is refused | Form MD-37 |
| Memorandum to Medical Device Testing Officer | Form MD-38 |
| Application for grant of registration to Medical Device Testing Laboratory for carry out Test or Evaluation of a medical device on behalf of manufacturer | Form MD-39 |
| Certificate of registration to Medical Device Testing Laboratory for carry out Test or Evaluation of a medical device on behalf of manufacturer | Form MD-40 |
| Application for grant of registration certificate to sell, stock, exhibit or Offer for sale or distribute a medical device including in vitro diagnostic Medical device | Form MD-41 |
| Registration certificate to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device | Form MD-42 |
| Free Sale Certificate | - |
| Non-Conviction Certificate | - |
| Market Standing Certificate | - |
As manufacturers, importers, and stakeholders in the medical device industry, it is essential to be aware of the different types of CDSCO approvals and the regulatory processes to meet the highest standards of compliance and deliver safe and effective medical devices to the Indian healthcare system.