India Medical Device Regulations and the Indian medical regulatory system have become more complicated in recent years. In the past, medical devices did not need to be approved at all, but that is not the case today. In India, there are about 30 device “families” that outline which specific medical devices need to be registered.
India Medical Device Regulations represents a compelling market opportunity for global medical device manufacturers, with the majority of medical devices sold in India imported from other countries. Substantial growth for the Indian medical device industry is expected to be driven by the current low per person spending rate for medical devices.
When it comes to CDSCO medical device license process, Operon Strategist makes the lengthy process easy and smooth with the best technical team working for you, along with excellent assistance, timely responses and affordable fees structure.
Manufacturers interested in registering their medical devices in India must supply proof of approval in their home market. Providing further evidence of prior regulatory authorization in the US, Canada, Europe, Australia, or Japan can ease some regulatory requirements. India Medical Device Regulations your technical documentation must be submitted for review by the CDSCO. In addition, you must register all of your device manufacturing facilities.
Historically, medical devices in India have been mostly unregulated. That has changed in recent year. Ministry of Health and Family Welfare Notification No. G.S.R, 78(E) dated 31st January 2017 notifies Medical Devices Rules 2017, has come into force with effect from 1st January 2018.
Starting April 1, 2020, India rolls out new regulations that cover virtually every kind of medical device sold in the country — notified or not. Published in India’s Gazette (similar to the Federal Register in the U.S.) Feb. 11, 2020, the updated regulations require all device makers to conform to ISO 13485 standards regardless of the source of manufacture.
Who regulates medical devices in India?
Indian authorities overhauled the medical device regulatory process in 2017 with the publication of the Medical Device Rules. The rules came into force in January 2018 and devices are regulated by the Central Drugs Standard Control Organization (CDSCO), an agency of the Ministry of Health and Family Welfare.
India Medical Device Regulations
The Indian medical industry is in focus due to the COVID-19 pandemic and the consequent increase in demand for test kits, ventilators and other medical equipment. The Medical Device Rules, 2017 (the Rules) under the Drugs and Cosmetics Act, 1940 (the Act) govern the Indian medical device industry. These Rules came into effect on January 1, 2018.
The Rules are applicable in respect of:
- Substances used for in-vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component bag with or without anticoagulant covered under sub-clause (i) of section 3(b) of the Act;
- Substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii) of section 3(b) of the Act;
- Devices notified from time to time under sub-clause (iv) of section 3(b) of the Act
The government had notified 37 categories of devices under the sub-clause (iv) Section 3(b) of the Act for stricter regulation under the Rules.
The devices which did not come under the notified categories earlier required a ‘no objection certificate’ from the Drugs Controller General of India (DCGI). However, a notification issued by the Government on February 11, 2020 which came into effect on April 1, 2020 has made it mandatory to register all devices and provided a new procedure for the same.
On the same date government vide another notification amended the definition of medical devices which also came into effect on April 1, 2020.
who approved medical equipment in India
The Central Drug Standards Control Organization (CDSCO) is India’s main regulatory body for pharmaceuticals and medical devices.
The Drug Controller General of India (DCGI) is the key official within the CDSCO. The DCGI is responsible for the approval of the manufacturing of certain drugs (vaccines, large volume parenterals, blood products, r-DNA derived), specific medical devices, and new drugs.
In India, the manufacturing, import, sale, and distribution of medical devices are regulated under India’s Drugs & Cosmetic Act and Rules (DCA).
Regulated medical devices imported from outside of India that have obtained prior approval in the U.S., the European Union (EU), Canada, Japan or Australia may legally be sold in India by submitting the application and getting necessary license which lead to limited conformity assessment process.
In such cases, device registration applicants must submit all documentation used in support of prior approvals with their application. Foreign manufacturers must also appoint an importer holding a valid wholesale license, and who is responsible for submitting an India Medical Device Regulations application and dossier to the CLA.
India’s medical device quality regulation
The standards of quality and safety of medical devices are regulated in India by a law called The Drugs and Cosmetics Act, 1940 (“DCA”). The scope of DCA is restricted to only those medical devices which are notified by the Government from time to time as “drugs” (commonly referred to as “notified medical devices”).
The notification of the new (and comprehensive) definition of medical device has brought finality to the issue of regulation of all medical devices that has haunted the government and Indian consumers for a long time. The Government has now given sufficient time for the industry to adopt ISO 13485 and obtain registration for hitherto unregulated medical devices. Now, the onus is on the industry to do its part and reinforce the belief of the Indian consumer and the international community in the quality and safety of medical devices sold in India.
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