In the ever-evolving world of healthcare, the development and introduction of  new medical devices play a pivotal role in enhancing patient care and advancing medical science. However, before such innovative devices can reach healthcare professionals and patients, they must achieve compliance with a comprehensive Regulatory framework. In India, securing a manufacturing or import license for new medical devices is a multifaceted process that involves compliance with stringent rules and regulations.

Medical device grouping in India is a Regulatory process that enables manufacturers and importers to register multiple devices under a single license. Regulated by the Central Drugs Standard Control Organization (CDSCO), the grouping guidelines specify how companies can group their medical devices for import or manufacture clearance. This classification simplifies the application process and saves time and costs for license applicants.

Who is an IAA?

From October 2023 onwards, the mandatory registration of Class C and D medical devices in India will require conformance with the Quality Management System (QMS) requirements, as per the Indian Medical Device Rules (IMDR) 2017. Thus, medical device manufacturers will have to implement a QMS that meets the requirements of Schedule V of the IMDR 2017. It is mandatory for manufacturers to be compliant with these requirements for the successful registration of their Class C and D devices.

In India, a medical device test license, issued by the Central Drugs Standard Control Organization (CDSCO), is a temporary license that allows a manufacturer to conduct tests on their medical device before they can obtain a permanent license for it. The test license allows the manufacturer to conduct clinical trials and other tests on the device and gather data on its safety and efficacy. The CDSCO requires the manufacturer to obtain this license to ensure that the device is safe and effective for patients’ use.

What is Loan License for a Medical Device?

A loan license is issued by the State Licensing Authority (SLA)/Central Licensing Authority (CLA) for manufacturing medical devices; it is an agreement between two manufacturers who grant the right to use their facilities and infrastructure for manufacturing the device. A company that wants to manufacture and market its medical device in India but does not have the necessary manufacturing capabilities for production should meet the Regulatory standards laid out by the Central Drugs Standard Control Organization (CDSCO).

A list of medical devices that fall within the Class A, Class B, Class C, and Class D categories were included in the 2017 New Medical Device Regulations (MDR). Based on the level of risk they pose, Class A and B devices are categorized as low-risk and moderate-risk devices, respectively, whereas Class C and D devices are classified as high-risk and extremely high-risk devices, respectively. To be approved for a manufacturing license in India, manufacturers of Class C and D devices must submit an application to the Central Drugs Standard Control Organization (CDSCO).

The Indian medical device industry is amongst the top 20 markets worldwide and considered as one of the fastest growing. Since approximately 80% of the Indian medical device needs are met through imports, it is essential to have a strong medical devices regulatory regime. The Indian regulatory agency, the CDSCO, make a conscious effort to improve their regulations to release safe and efficient medical devices into the market.

The Union Ministry of Health (MoH), India has released a draft Gazette Notification – Medical Devices (Amendment) Rules, 2021. These rules are an amendment to the original “Medical Devices Rules, 2017”, published on January 31, 2017, in the Official Gazette under the Notification No. G.S.R.78(E). The amendment rules read –

“In the Medical Devices Rules, 2017, in rule 7, in sub-rule (2), after the words, letters and bracket “the

Medical device industry has been a booming industry with new technologies being introduced from time to time and has been dynamic in terms of Regulatory landscape. The year 2020 has seen a major disruption due to the COVID-19 Pandemic and demanded the Health Agencies to gear up for addressing the pressing situation, thus impacting the Agency’s plan of action.