The Central Drugs Standard Control Organisation is the highest Indian regulatory body that oversees the production of medical devices that have been approved (CDCSO). In India, the regulatory authority is in charge of licencing and approving the production of medical devices. FORM MD-7 and FORM MD-9 are used by this regulatory agency to issue manufacturing licences, as required by the Medical Device Rules of 2017[1].
According to the 2017 New Medical Rules, all medical devices have been divided into four distinct categories. Class A, Class B, Class C & Class D, respectively. Any company that aims to manufacture these devices for distribution and sale must submit an application to CDSCO for a manufacturer’s licence.
Governing bodies for Medical Devices in India
Both the Central Government & the State Government play significant roles in the enforcement and administration of the New Medical Device Rules. CDSCO coordinates with the State Government to ensure uniform rule enforcement.
- Central Government:
Central Licensing Authority (CLA) – Drugs Controller General of India serves as its head. The CLA governs the use of FORM MD-7 and FORM MD-9. It serves the following functions-
- Import of All Classes of Medical Devices.
- Production of High-Risk Medical Devices (Class C & D).
- Permission for medical device clinical investigation.
- Permission for Clinical Evaluation of In-vitro Diagnostic Performance.
- Authorisation of investigational medical devices and novel in-vitro diagnostics
- Coordination with the State Licensing Agency.
- State Government: State Licensing Authority (SLA) – State Drug Controller is in charge of-
- Manufacturing of low-risk (Class A & B) medical devices for sale or distribution.
- Authorisation for the sale or distribution of all types of medical devices.
Form MD-7 and Form MD-9: Meaning
A manufacturing licence application is made using Form MD-7 and Form MD-9 is the licence to manufacture Class C or Class D medical devices for sale or distribution. Form MD-7 is used to submit an application for a licence to manufacture Class C and Class D medical devices for sale and distribution, while Form MD-9 is used to obtain the licence to manufacture Class C and Class D medical devices.
Form MD-8 must be used to submit an application for a loan licence to manufacture Class C and Class D medical devices for sale and distribution, and Form MD-10 can be used to obtain the loan licence to manufacture Class C and Class D medical devices. Due to the high risk classification of Class C and Class D medical devices, the application process is extremely stringent.
Classification of Medical Devices Based on their Risk Levels
- Class A – low risk
- Class B – moderate to low risk
- Class C — moderate to high risk
- Class D – high risk
Class A & Class B medical devices are considered low- and moderate-risk, respectively. The State Licensing Authority must receive the application for manufacturing medical devices belonging to these classes. Class C and Class D devices are classified as High and Extremely High Risk devices, respectively. The application for their production must be submitted to the Central Licensing Authority.
The manufacturer who wishes to be granted a Loan License for the further sale and distribution of class B and C medical devices must submit an online application through the Ministry of Health and Family Welfare’s online portal in the Central Government, via the Central Licensing Authority, using FORM MD-7 and FORM MD-9.
What does the Application for Manufacturing License Include?
- A cover letter, a plant master file, and a device master file
- Quality Management System specified in accordance with the 5th schedule of Medical Device Rules, along with a performance evaluation report (IVDs only)
- Constitutional information about the organisation, the establishment/site possession
- Copies of duly notarised, valid Quality Certificates for the manufacturing site
- Possession of a valid Test License for checking and generation of quality control data
- A signed undertaking stating that the manufacturing site complies with the requirements of the Fifth schedule.
Validity of Manufacturing License Received in Form MD-9
The validity of the licence received in Form MD-9 is for a period of 5 years; it is perpetual, subject to the timely payment of the license retention fee within 5 years of the date of issuance, as per the Second Schedule, unless suspended or revoked by the Central Licensing Authority. In case the payment is not made on time, the licence is suspended or revoked.
Conclusion
The State Licencing Authority (Class A and Class B devices) and the Central Licencing Authority are responsible for issuing certifications (Class C and D devices). On January 1, 2018, the Medical Device Rule, the new Indian Regulation, went into effect. Every medical device must bear a Unique Device Identifier beginning January 1, 2022. (UDI). To be sold in India, medical devices must be registered with Regulatory Authority. Regarding Class A and Class B medical devices, the documentation must be submitted to State Licencing Authority, which will issue Form MD-5 certification. While documentation for Class C and Class D devices must be submitted to the Central Licencing Authority, which will issue Form MD-7, Form MD-9 (for Class C devices), and Form MD-8 (for Class D devices) (for Class D devices).
Read our Article:What are Form MD-8 and Form MD-10?
