The Medical Devices and Rules, 2017 maintains the guidelines to provide a framework of the rules and regulations of Drugs, Medical Devices, Medical related products, IVDs etc. To manufacture the medical devices, the manufacturer also needs to acquire a manufacturing license from the licensing authorities. The same is the case with acquiring a loan license for medical devices. A Medical Device Loan License is provided by the relevant licensing authority. For the Medical devices of Class A and B, the loan license is granted by the State Licensing Authority, whereas the Central Licensing Authority is responsible for granting the Loan License to Class C and D medical devices, as per their risk levels.
Forms required for loan license for medical devices
To acquire a medical device loan license, there are two steps involved-
- Application of obtaining a loan license for the purpose of manufacturing or selling medical devices of Class A, B, C and D.
- Obtaining the loan license for the purpose of manufacturing or selling medical devices of Class A, B, C and D after approval of the relevant licensing authorities.
According to the medical device rules 2017, The Medical Device Loan License has to be obtained according to the Classes of Medical Devices based on the risks involved.
The risk involved in Class A and B medical devices is Low and Low-medium, respectively, whereas the risk involved in Class C and D medical devices are Medium-High and High, respectively. To obtain a medical device loan license, there are two licensing authorities that provide approval to the devices according to their risk categories; these authorities are-
- State Licensing Authority.
- CentralLlicensing Authority.
The State licensing authority is responsible for the approval of loan license for the manufacture or sale of Class A and B medical devices, whereas the Central licensing authority or the CDSCO is responsible for the approval of loan license for the manufacture or sale of Class C and D medical devices. There is a specification of forms required for the application for a loan license and a Form provided by the licensing authority as the grant of a Loan License, according to the different categories of the devices mentioned below-
|Application Form||Approval Form||Class RISK||Licensing Authority|
|MD-4 Application of loan license||MD-6 Grant of loan license||Class A and class B medical devices||State licensing authority or SLA|
|MD-8 Application of loan license||MD-10 Grant of loan license||Class C and Class D Medical Devices||Central Licensing Authority or CDSCO|
Approval for Medical Device Loan License
The State Licensing Authority (SLA) or the Central Licensing Authority (CLA)/ CDSCO is responsible for the approval of the medical devices loan license in India. For medical devices of Class A and B, the State Licensing Authority is responsible, whereas, for Class C and D, The Central Licensing Authority or CDSCO is responsible. For medical device loan licenses or Class A and B medical devices, The SLA, after accepting the applications in form MD-4, provides a grant or approval of Loan License in form MD-6. Whereas, after obtaining applications for Class C and D medical devices in form MD-8, the SLA provides permission for Loan License in form MD-10.
Conditions for obtaining Medical Device Loan License in India
According to the Medical Devices Rules (MDR) 2017, the State Licensing Authority and Central Licensing Authority provide approval for the medical device loan license for Class A and B through form MD-6 and for Class C and D through form MD-10. After receiving a grant for loan license, the following conditions are required to be followed by the license holder-
- The license holder is required to produce his license whenever requested by any medical device officer or any officer from SLA and CLA.
- In case of any suspected or unforeseen serious incident, the license holder is required to inform the SLA or CLA about the incident and emergency actions taken for the same within 15 days of the incident.
- Before making any major changes, the license holder must get approval for the same. The request should be made as per the Sixth Schedule. After getting the approval, the license holder is required to submit the details of the changes to the SLA or CLA within 45 days.
- According to rule 83, sub-rule (3), the license holder is required to perform tests in the laboratory before the products are released. All the test documents are required to be submitted in CLA or SLA.
- The audit should be documented inform MD-11
- The test samples are required to be preserved for 180 days post expiry.
- The manufacturing and sales records should be kept safe by the license holder and are required to be produced to the medical officer whenever requested.
- If the manufacturing of the device has stopped for more than 30 days, the manufacturer should inform the same to the CLA or SLA.
Documents required for the Medical Device Loan License-
The documents required for the purpose of obtaining a Medical Device Loan License for Class A and B medical devices along with Form MD-4 are accompanied by the fee, which is specified in the Second schedule. The documents which are required in obtaining Loan License are specified in Part II of the Fourth Schedule.
The documents required for the purpose of obtaining a loan license for classes C and D, along with the form MD-8, are accompanied by the fee, which is specified in the second schedule. The details of the required documents are specified in clause (ii) of part II of the fourth schedule.
Application for Medical Device Loan License
In order to obtain Loan License for the medical devices, the manufacturer first needs to submit an application for approval of a loan license to manufacture or sell medical devices. Different medical devices require different forms to be filled for the same purpose. For class A and B medical devices, form MD-4 has to be filled and submitted to the State Licensing Authority in order to proceed with the further loan license proceedings. For class C and D medical devices, form MD-8 is required to be filled and submitted to the Central Licensing Authority or CDSCO to proceed further with the Loan license acquiring process.
Procedure for obtaining Medical Device Loan License
In order to obtain Loan License for Medical Device for Class A, B, C and D, the following procedures are required to be followed-
- The applicant is required to register himself with the Ministry of Health and Family welfare.
- Form MD-4 is required to be filled by the manufacturer in order to apply for a loan license for Class A & B medical devices.
- Form MD-8 is required to be filled by the manufacturer in order to apply for a loan license for Class C and D medical devices.
- All the vital documents must be uploaded according to sub-rule (1).
- The applicant of both form MD-4 and MD-8 must upload the important paperwork before submitting the undertaking as specified by the Quality Management System.
- The submitted application of form MD-4 is investigated by the state licensing authority, and Form MD-8 is submitted by the Central Licensing Authority.
- Once the application is checked by the concerned licensing authorities, the application is then approved in the form MD-6 for classes A and B and MD-10 for Class C and D loan licenses.
- If in case the license is rejected, the CLA and SLA are required to notify the applicant within 45 days in writing.
Validity of Medical Device Loan License
The loan license issued in the form MD-6 and MD-10 remain valid for the time period of five years, where it is essential for the license holder is required to pay the license retention fee as specified in the second schedule before completion of the period of five years from the date of issue of license unless it gets cancelled. If in case the license gets cancelled, the applicant can file for an appeal under CLA or SLA within 45 days of cancellation.
A loan license is a license which is issued for the manufacturing of medical devices by the State Licensing Authority or the Central Licensing Authority. It is provided to a person who needs to use the manufacturing site of any other license holder for the purpose of manufacturing medical devices, where the real license holder also manufactures the same medical device as the loan licensee at that site. According to Rule 20 and Rule, 21 of Medical Devices Rules 2017, a manufacturer who has a manufacturing license but does not have sterilization facilities has to obtain a loan license in form MD-4 for class A and B medical devices and MD-8 for class C and D medical devices.
Read our Article:Documents needed for CDSCO Loan License