Licensing Authorities for Medical Device Product Registration in India

The medical device industry in India is growing rapidly, and it is expected that it shall continue to do so in the coming few years. As the Indian consumer is becoming more and more conscious about his health, there has been a huge demand for medical device production both domestically and internationally. The government had released the medical device rules in the year 2017 to regulate this market. These rules became applicable in 2018. The Central Drugs Standard Control Organisation (CDSCO) shall oversee these regulations. In this article, we shall learn about licensing authorities for medical device product registration and its procedure.

Government Bodies for Medical Device Product Registration in India

There are a few authorities that are involved in Medical device product registration in India; these are:

1. Drug Controller General of India

The Drugs and controller General of India overlooks the working of CDSCO. It creates standards for the sales, manufacturing, import and distribution of drugs in India. It also acts as the appellate authority in case of any disputes surrounding drug quality in India. DGCI also looks after the national reference standard for drugs in the country. DGCI also makes sure that the medical device rules are implemented uniformly in all the states.

• Central Licensing Authority: This authority shall function under the purview of the DGCI. This shall be the competent authority to enforce the rules that relate to importing all medical devices in India. The central licensing authority shall also be responsible for the manufacture of Class C&D devices. They shall also conduct proper inspection, investigation and evaluation of in vitro medical devices and coordinate with the State licensing authorities.
• State Licensing Authority: This body also comes under the DGCI. It is also known as a state drugs controller. This authority is responsible for enforcement of the rules for the sale, manufacture and distribution of Class A or Class B medical devices in the country. SLA shall also exhibit, stock or sell medical devices across the Classes.

1. CDSCO- Central Drugs Standard Control Organisation (CDSCO):

The CDSCO was created under the Directorate General of Health Services, Ministry of Health & Family Welfare. The main department is in New Delhi, followed by six zonal, 4 Sub zonal and 13 port offices and seven labs in the country. The CDSCO ensures that medical products in the country conform to the safety norms and effectively carry out their functions. They also work to ensure that imported medical products also are of good quality and safe for Indian users. The CDSCO conducts clinical trials, lays down standards of conformity and sets rules for the manufacturers of drugs in the country. The CDSCO also constantly works and coordinates with the State agencies to uniformly enforce the Drugs and Cosmetics act.

Statutes for Medical Device Product Registration in India

Two statutes govern Medical device registration. Any stakeholder that is involved with Medical device registration must comply with the rules in these regulations. These are:

• Drugs and Cosmetics Act, 1940

The government created the Drugs and cosmetics act to control the manufacture, import and sale of medicines in India. The primary objective being that cosmetics and drugs sold in the country adhere to standards and are safe and effective. The act deals with the import of drugs, thereby ensuring that no substandard medicines are dumped into the country. The act also facilitates the selling of drugs by trained and competent individuals, including Ayurveda and homoeopathic drugs. The act also specifies that timely samples must be collected, and they should be studied in recognised laboratories. The act specifies eight medical items that are regulated by it; these are; 1. Bone Marrow Cell Separator, 2. X-Ray machine, 3. Dialysis machine, 4. PET Equipment, 5. Defibrillators, 6. MRI Equipment, 7. CT scan Equipment, 8. All implantable medical devices.

• Drugs and cosmetic Rules, 1945

The Drugs and cosmetic rules of 1945 are a supplement to the drugs and cosmetics act of 1945^[1]. The rules specify how the medicine should be classified, stored, displayed and distributed. The terms of licences for drugs are specified in Rule 67, and the Restriction on labelling is found in Rule 97.

• Medical device rules, 2017

The medical devices rules, 2017, have been created under Drugs cosmetic acts. The rules state the requirements that need to be followed by manufacturers/ importers/marketers/sellers of the notified medical device. The rules have made it mandatory for all the stakeholders involved with medical devices to obtain a license before undertaking any activity related to such devices. These licenses shall be granted after going through several quality checks. The rules have also widened the ambit of the term ‘drugs’ to encompass various medical devices under it. Further, the act has also classified the medical device from Class A-D based on the risk that each category carries with itself. A total of 37 categories of medical devices have been laid down under these rules. They shall fall under the category of ‘newly notified medical devices.

Conclusion:

Medical Device Product Registration in India has become mandatory. A manufacturer/importer or seller requires to deal with various licensing authorities. These include DGCI, CDSCO, state licensing authority, and central licensing authority. The procedure of obtaining the licenses should be as per the norms laid down under the Drugs and Cosmetics Act and rules, as well as the Medical device rules of 2017.

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