CDSCO Medical Device Loan License

Medical Device Loan License
Ganesh Nair
| Updated: Sep 08, 2022 | Category: CDSCO

The Ministry of health and family welfare (MoHFW) and the CDSCO have enacted the rules of the Medical device, 2017. The rules have been created to make sure that only those medical devices that meet quality and safety control standards are used in the healthcare industry. The rules also classify the medical devices as per the risk it poses; this lets the patient have access to safe and quality medical devices. The rules have also made it mandatory for manufacturers and importers to get registered and obtain a license for manufacturing. In case the manufacturer requires a loan, he has to fill in the form MD-4 & 8 for ‘Medical device Loan license’. This article shall try to educate the reader about Medical device Loan licenses in India.

What are the important forms for Medical Device Loan License?

S.no Description Application form Approval form Fees Rule Licensing Authority
1. Manufacturing licence or loan License for Class A or Class B medical device MD- 3 (for license) MD-4 (for loan) MD- 5 (for license) MD-6 (for loan) ₹5000- registration of one plant/site₹500 for registration of one product 20 (2) and 20(4) State licensing Authority
2. Manufacturing licence or loan licence to manufacture Class C or Class D medical device MD- 7 (for license) MD- 8 (for loan) MD- 9 (for license) MD-10 (for Loan) ₹50,000- registration of one plant/site₹1000 for registration of one product 21(2) and  25 (1) Central licensing Authority
3. Manufacturing licence or loan licence retention feeClass A, Class B, Class C, Class D medical device N/A MD-5, MD-6,
MD-9, MD-10
The retention fee is the same as above, however, this must be paid every 5 years 29 State Licensing Authority and Central Licensing Authority

Which authorities are responsible for granting the Medical device Loan License?

There are two authorities that grant loan licenses as per Medical device rules these are:

  • State licensing Authorities (SLA): authorities are set by the respective state government to issue medical licenses. It is the notified body that shall audit the manufacturing site of Class A and Class B medical devices. SLAs also provide manufacturing licenses, medical device loan licenses, and retention licenses to products that fall under categories A and B. It also has the power to suspend the entity’s licenses if they are not up to the standards set by medical device rules.
  • Central Licensing Authorities (CLA): CLA is established by the Drugs Controller General of India. It is the notified body that conducts, analyses and sets performance parameters for devices that fall under Class C and D. Moreover, it is the authority responsible for granting import licenses to Devices of all the categories from A-D. The Central licensing authority can also revoke the license of anyone if they are found flouting the rules or guidelines. Numerous times CLA and the SLA work together to ensure effective implication of the medical device rules in the country.

Documentation required for grant of Medical device Loan License

A comprehensive list of documents is to be submitted along with the prescribed forms for the Medical device Loan License. These are:

  • A cover letter
  • The Challan of the amount paid as per the medical device
  • Relevant declarations to be made as per Affidavit-1 shall include information such as partners, proprietors, directors etc.
  • An attested copy of the MoA, Partnership or Pan card (as applicable) is to be attached with the Affidavit
  • A Duly notarized document with the name, address and details of the required members that carry out day-to-day activities of the enterprise. This along with photographs and conduct of the business.
  • A letter of consent from the parent company ratifying the availability of resources and license details. CDSCO Loan license if already issued
  • Details and declaration of the technical staff that is involved in the process of production for analysis purposes
  • Details of any previous applied/ issued CDSCO loan license of the company.
  • Declaration regarding any formulations that were not applicable earlier or were prohibited by the authority due to association with the same/ different brand name
  • Packing details with all the list of formulations
  • Labels for all the specimens
  • Test methods opted for ingredients and products that are not in pharmacopoeia and any other Compendia of drug standards
  • Copy of monograph for drugs that are not present in I.P
  • A flow chart showing the production procedure with consumption co-efficient and effluents needed for the treatment

Process of applying for Medical device loan license

  • The applicant must be registered with the Ministry of health and family welfare.
  • The applicant must apply through the appropriate form, i.e. MD-4 for medical devices of class A & B and MD-8 for devices of class C&D
  • Next, the applicant must upload the form on the sugam portal[1], as per the guidelines. The applicant must ensure that all the relevant information is provided.
  • After this, the applicant must also upload all the prescribed documents.
  • Once the form is uploaded, the State licensing authority or the Central licensing authority shall scrutinise the application.
  • If the authorities approve, then the loan license shall be granted through forms MD-6 and MD-10.
  • In case the application is rejected, then the entity may file for the same after 45 days.

Validity of the Medical device loan license

The medical device loan license shall be valid for a lifetime. However, the applicant needs to pay the retention fee at the interval of five years. The failure to pay this shall make the license invalid/ cancelled. The entity may file an appeal in the next 45 days with SLA or CLA in such cases.

Conclusion

Medical device rules 2017 have a provision for manufacturers to apply for a medical device loan license. Entities must apply for this license if they do not have their own sterilisation facility and use other brands. Or if they want to sell or distribute medical devices through the online system of the medical devices portal.

Read our Article:What is Forms MD-14 and MD-15

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Ganesh Nair

Ganesh Nair completed his graduation in law from IP university. He is an ardent researcher who has written various research papers and articles on contemporary legal issues. His keen interest in the field of research made him pursue a career in legal research. His core area of interest include Cyber, IPR and Finance laws.

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