The Central Drug Standard Control Organization (CDSCO) is the National Regulatory Authority or NRA of India, which works under the Directorate General of Health Services, under the Ministry of Health and Family Welfare under the government of India. The DCGI is the head of CDSCO, responsible for issuing medical device rules and additional regulations. To improve India’s Drugs and Medical Device regulations, the Ministry of Health and Family Welfare notified the medical device rules, 2017. As per the new rules, the medical devices have been classified as Class A, B, C and D devices on the basis of the risks involved with them. Class A and B Medical Devices have Low and Low-Moderate risk, respectively, whereas Class C and D Medical Devices have Moderate and Moderate-High risk, respectively.
Medical Device Rules, 2017
On 31st January 2017, The Ministry of Health and Family Welfare notified the medical device rules, 2017. According to the rules, the manufacturing and Import license will remain valid unless it is revoked or cancelled. The entire process of applying for a license will be done online through the E portal. The SUGAM portal has made the CDSCO medical device registration process easier and more convenient. Applications for Class A and B Medical Devices can be submitted online on the SUGAM portal, where the approval will be granted by the SLA or State Licensing Authority; Applications for Class C and D Medical devices are approved by the CLA or Central licensing authority through SUGAM portal.
To submit an application for the manufacturing license for Class A and B Medical Devices, the application for the manufacturing license is submitted to the State Licensing Authority of the state where the manufacturing unit is located. The same procedure is followed for submitting a loan license for Class A and B medical Devices, with certain additional requirements.
Categorization of the Medical Devices
According to the Medical Device Rules 2017, medical devices have been divided into four different categories according to the risk classification of the devices. For the purpose of obtaining a manufacturing or loan license for Class A and B medical Devices, the applicant must choose the correct categorization of the devices according to their risk classification.
|Application Form||Approval Form||Class Risk||Licensing Authority|
|MD-3- Application of manufacturing License||MD-5- Grant of manufacturing License||Class A and Class B Medical Devices||State Licensing Authority|
|MD-4 Application of loan license||MD-6- Grant of loan license||Class A and class B medical devices||State licensing authority|
The licensing authorities have made rules solely on the basis of the risks involved with the devices -. The permission for license or manufacturing of these devices is given only after analysing the risks involved in different categories of the devices.
Manufacturing License for Class A and B Medical devices in India
For the purpose of applying for and obtaining a license for manufacturing of Class A and Class B medical devices, form MD-3 and MD-5 are used. The permission is granted by the State Licensing Authority of India. Form MD-3 is an application form for the purpose of obtaining a license to sell, manufacture or trade Class A and B medical Devices in India. The CDSCO certificate is granted as per the format under Form MD-5 by the SLA as a permit or license to manufacture, sell, or distribute a Class A or Class B Medical Device.
Loan License for Class A and B Medical devices in India
To apply for a Loan license to manufacture, sell or distribute Class A and B medical Devices in India, form MD-4 and MD-6 are used. The permission for the same is also granted by the State Licensing Authority of India. Form MD-4 is submitted as an application for obtaining a loan license for the manufacturing, sale or distribution of Class A and B medical Devices in India, whereas Form MD-6 is a form given by the SLA as approval of a loan license for the purpose of manufacture, sale or distribution of Class A and B medical Devices.
Application Procedure for obtaining CDSCO License for Class A and B Medical Devices in India
In order to apply to obtain the license for manufacturing and loan license for Class A and B medical devices in India, the following steps are to be followed-
- The first step is the registration of the applicant with the Ministry of Health and Family Welfare.
- After registration, the applicant must upload Form MD-3 on the SUGAM portal along with the relevant details and required documents.
- If the applicant is applying for a loan license, he must upload Form MD-4 with all the required documents and details. The form and fees are submitted according to the Second Schedule of Part III.
- After submitting the form and the required documents, the applicant must submit an undertaking as required by the Quality Management System.
- The State Licensing Authority then checks and verifies all the relevant details and documents submitted by the applicant. The State Licensing Authority is responsible for approving licenses only for Class A and B medical Devices. Class C and D medical devices are governed by the Central Licensing Authority. Therefore, any misclassification of medical device at the time of filing the license application may lead to immediate rejection by the SLA.
- After all the relevant documents are verified, the SLA grants a manufacturing license or a loan license to the applicant through the Form MD-5 and MD-6, respectively.
- If in case, the license is rejected, the State Licensing Authority notifies the applicant within 45 days in writing, mentioning the reason for such rejection.
The medical device sector has developed rapidly over time and plays an important role in every part of healthcare sector. It plays a major role in getting an easy access to the healthcare services, due to which there has been a rapid increase in the import and manufacture of the medical devices in India. There is an anticipation in the growth rate of revenue in medical device Industry by 13.01%, by the year 2027, with an approximate market volume of ₹ 860.30 billion.
While there is a much larger scope for the medical device market, the manufacturers in contrast, are concerned about the complex differentiation of the medical devices as per their risk and class. Improper registration process can lead to losses in business or sales and can hamper supply. The regulations in medical device market are also subject to price limits. Moreover, once a medical device gets registered, there is a necessary requirement of a license in order to manufacture, sell or import the medical devices. One small mistake in the registration process can lead to a chain of huge losses. Because of the complexity of the process, it is always advisable to get professional help and guidance in such complex tasks, because one minute mistake can lead to cancellation of license, which may cause delay in the entire process and hamper millions of lives.