Due to the large population, high demand and quick expansion of the medical device business, Indian medical device manufacturers are in favour of the establishment of medical device manufacturing units. The medical device rules 2017 were introduced in order to meet the global standards of the medical device industry. There is a classification of medical devices on the basis of the risks involved. The devices are divided into Class A, B, C and D on the basis of the risk levels involved along with the device. The medical devices are required to be registered first in order to be imported, sold or manufactured in India. In order to obtain registration certificate of the medical device, it is mandatory to submit an application for the same. Application Procedure for Class C and D Medical Devices are regulated by the Central Licensing Authority, whereas Application Procedure for Class A and B Medical Devices are regulated by the State Licensing Authority of India.
Medical Device Rules 2017 – An Overview
The Medical Device Rules, 2017 were brought into effect on January 1st 2018, by the CDSCO. The Central Drug Standard Control Organization (CDSCO) divided medical devices in India into four different classes- Class A, B, C and D. Under this classification, medical devices are categorized based on the risks involved. The different classes of devices involve different licensing procedures and requirements. The categorization has been implemented to make sure that the patients get good quality service and treatments from Medical Devices, and the market should not have access to any unsafe, unregistered or uncertified medical devices. The Medical devices, on the basis of the risks involved, are categorized into four classes-
- Class A– Devices that have low risk, for example- thermometers and sphygmomanometers
- Class B– Devices that have low to medium risk, for example- needles and suction cannula
- Class C- Devices that have medium to high risk, for example- ventilator and joint implants
- Class D– Devices that have high risk, for example- pacemakers and heart valves
The Indian Government has also released multiple notifications to include new medical devices under different categories to keep up with innovation in the medical device sector. This has been done to ensure that new medical devices in the market do not go unchecked and uncovered from the ambit of MDR, 2017.
In order to import or manufacture Class C and D medical devices in India, the manufacturer must obtain prior permission in the form of a manufacturing and Import license. The Central Licensing Authority or CLA is responsible for providing permission for the same and handling any other operations or functions relating to Class C and D medical devices. All the applications for the manufacturing license or loan license for Class C and D medical devices are submitted to the CLA under CDSCO.
Class C and D Medical Devices in India
With different levels of risk involved, it is important to group different medical devices according to their correct classification. The Central licensing authority (CLA) has made certain rules relating to the procedure to obtain CDSCO medical device registration for Class C and D Medical devices. Therefore, to successfully the permission to manufacture or a loan license for the manufacture or sale of Class C and D Medical devices, it must be ensured that the application is filed as per the right Form and procedure. The following table provides a framework of the entire licensing process for Class C and D Medical devices in India.
|Application Form||Approval Form||Class RISK||Licensing Authority|
|MD-7: Application of Manufacturing License||MD-9: Grant of manufacturing License||Class C and Class D Medical Devices||CDSCO|
|MD-8: Application of loan license||MD-10: Grant of loan license||Class C and Class D Medical Devices||CDSCO|
Manufacturing License for Class C and D Medical Devices in India
In order to apply for a manufacturing license and to obtain a license for manufacturing Class C and Class D medical devices, Form MD-7 and MD-9 are required. The medical device manufacturing license is granted by the Central Licensing Authority of India or CDSCO. Form MD-7 is an application form submitted to the CLA in order to obtain a license to sell, manufacture or trade Class C and D medical Devices in India. MD-9 is issued by the CLA as a license or approval to manufacture, sell, or distribute a Class C and D Medical Device.
Loan License for Class C and D Medical Devices in India
In order to apply for a loan license for manufacturing Class C and Class D medical devices, Form MD-8 and MD-10 are required. The loan license for Class C and D devices is also granted by the Central Licensing Authority of India or CDSCO. Form MD-8 is submitted to the CLA in order to obtain a loan license to sell, manufacture or trade Class C and D medical Devices in India. MD-10 is a form which is granted by the CLA as approval of a loan license to manufacture, sell, or distribute a Class C and D Medical Device.
Licensing Procedure for Class C and D Medical Devices in India
In order to obtain the license for manufacturing and a Loan license for Class C and D Medical Devices in India, the following procedure is involved-
- The applicant must register themselves with the Ministry of Health and Family welfare.
- After registration, the applicant must submit Form MD-7 on the portal along with their business details and supporting documents.
- If the applicant is applying for a loan license, he must upload Form MD-8 with all the relevant documents and details. The form and fees are laid down in the Second Schedule of Part II of the Rules. The Central Licensing Authority or CDSCO then checks and verifies all the relevant details and documents filed by the applicant. The CDSCO grants license only for Class C and D medical Devices. Class A and B medical devices are governed by the State Licensing Authority.
- After all the relevant documents are verified, the CDSCO grants a manufacturing license or a loan license to the applicant through the form MD-9 and MD-10, respectively.
- If, in case, the license is rejected, the Central Licensing Authority or CDSCO notifies the reason for such rejection to the applicant within 45 days in writing.
The Indian medical device market is growing at an increasing rate. India is marked as the 4th largest medical device market in the world. The medical device Industry is expected to increase its revenue by 13.01%, by the year 2027, with an approximate market volume of ₹ 860.30 billion. Because of a wide range of rules and regulations governing a single registration process, the process can become extra lengthy. Although the Government is still working hard to simplify the complicated paperwork and regulations, but the entire landscape is still very complicated. A single mistake in one step can lead to huge financial losses and even the cancellation of a license. Therefore, it is always advisable to get professional help while getting any sort of medical license.
Read our Article:Application Procedure for Class A and B Medical Devices