According to the Medical Devices Rules of 2017[1], any business seeking a loan licence to produce Class A or Class B medical devices must submit an application. In vitro diagnostic devices may also be categorised as Class A or Class B medical devices because they are low and low-to-moderate risk devices. The manufacturer must submit an online application through the Ministry of Health and Family Welfare’s online portal via the State Licensing Authority, using Form MD-4 and Form MD-6, in order to be granted a Loan License for the continued sale and distribution of class A and Class B medical devices. Form MD-4 may be used to apply for a Loan License to Manufacture for Sale or Distribution of a Class A or Class B medical device. In this write-up, we will discuss Form MD-4 and Form MD-6.
Regulatory Bodies
Depending on the category of medical device, the regulatory responsibilities have been split between the State and Central Governments. The State Licensing Authority (SLA) is in charge of overseeing the production of Class A and B medical device through FORM MD-4 and FORM MD-6. All four classes of devices will be sold and distributed under its supervision.
Classification of Medical Devices in India
The medical devices are classified into the following 4 categories based on the risk involved in usage:
- Class A: Low risk devices
- Class B: Low to moderate risk devices
- Class C: Moderate to high risk devices
- Class D: High risk devices
Form MD-4 and Form MD-6: Meaning
Applications and permits for the sale and distribution of medical devices are submitted using FORM MD-4 and FORM MD-6 respectively. While Form MD-6 provides Loan Licence to manufacture for sale or distribution of Class A or Class B Medical Device. Form MD-4 is used as an application for grant of Loan licence to manufacture for sale or distribution of Class A/Class B Medical Device.
What is a Medical Device Manufacturing License?
A medical device manufacturer or distributor can apply for state licencing through the State Licensing Authority to sell or distribute their products. The application procedure entails requesting a grant, loan, or licence to sell or distribute. In accordance with the Medical Devices Rules, 2016, the application and licence may be submitted online through Form MD-4 and Form MD-6 at the Ministry of Health and Family Welfare. Class A and Class B, medical devices fall under this category.
Requirements for Granting a Manufacturing or Loan License through Form MD-4 and Form MD-6
The holder of a licence must adhere to the following conditions after receiving a grant of licence or loan licence through Form MD-4 and Form MD-6:
- When the Medical Device Officer or any other senior official from the Central Licensing Authority or State Licensing Authority requests it, the licence must be produced.
- The licence holder should notify the State Licensing Authority or the Central Licensing Authority of any suspected unexpected serious adverse event and inform them of the action taken within 15 days.
- Before making any significant changes, the licence holder should get permission. The Sixth Schedule specifies that the request be implemented. Following approval, the licence holder must provide the information to the State Licensing Authority or Central Licensing Authority within 45 days.
- In accordance with rule 83’s sub-rule (3), the licence holder must conduct laboratory tests prior to releasing the products. The Central Licensing Authority or the State Licensing Authority should receive all test documentation.
- Form MD-11 must contain documentation for every audit.
- Following expiration, all test samples must be stored for 180 days.
- The licence holder must keep track of sales and manufacturing, and must appear when the medical officer requests it.
- The Central Licensing Authority or the State Licensing Authority should be notified if the medical device manufacturer stopped producing the devices for more than 30 days.
Application Procedure for Class A and Class B License Grants Loans – Form MD-4 and Form MD-6
- The applicant must register with the Ministry of Health and Family Welfare.
- To submit an application for a licence, the applicant must upload the Form MD-3 with all required information.
- To submit an application for a loan licence, the applicant must upload the Form MD-4 with all necessary information. As stated in the Second Schedule of Part II, the form must be uploaded along with the fee.
- In accordance with the applicable sub-rule, all relevant details must be uploaded.
- The applicant must upload the necessary paperwork before submitting the undertaking as specified by the Quality Management System.
- The State Licensing Authority shall investigate the submitted application.
- The State Licensing Authority must issue the manufacturing licence in Form MD-5 after probing.
- The State Licensing Authority must provide the loan licence in the form MD-6.
- The State Licensing Authority must send a written notice to the applicant within 45 days if the licence is rejected.
Validity of a License
If the licence is not revoked or suspended by the State Licensing Authority, the validity of a licence that was issued in Form MD-4 and Form MD-6 will continue to be valid for an infinite amount of time, provided that the licence maintenance fee is paid in accordance with the Second Schedule before the end of the period of five years that begins on the date the licence was issued.
Conclusion
The primary regulatory body for medical devices in India is the Central Drug Standards Control Organization (CDSCO). The CDSCO’s top representative is the Drug Controller General of India (DCGI). The DCGI is in charge of approving the production of medical devices. It is necessary for manufacturers and sellers of medical devices to have a CDSCO licence. Each country has a dedicated oversight body under the ministry of health to look after each component of medical devices. Applications for licences to produce Class A and B devices for distribution or sale should be submitted online using Form MD- 3 or Form MD- 4 (for loan licences), along with a fee. The Form MD-5 or Form MD- 6 will be used to apply for the licence (for loan license).
Read our Article:What is FORM MD-3 and FORM MD-5?
