Regulation of Medical Devices Under CDSCO Guidelines

CDSCO, or the Central Drugs Standard Control Organisation, is the National Regulatory Authority in India for Cosmetics, Pharmaceuticals, and Medical Devices. The Drug Controller General of India (DCGI) within CDSCO oversees the regulation of pharmaceuticals and medical devices, operating under the Ministry of Health and Family Welfare.

The Indian Government has announced plans to review all Medical Devices, including implants and contraceptives, under the regulatory framework.

What Are Medical Devices Under CDSCO?

A medical device, as defined by CDSCO, encompasses any article, instrument, apparatus, machine, implant, or reagent designed for use in diagnosing, treating, mitigating, preventing, or managing diseases, disorders, conditions, or pregnancies in humans or animals.

Classification and Types of Medical Devices Under CDSCO

Medical devices are categorized into four risk-based classes under CDSCO, which require specific licensing for activities such as sale, distribution, import, and manufacture in India.

Category A: Low risk
Category B: Low to moderate risk
Category C: Moderate to high risk
Category D: High risk

CDSCO oversees approximately 200 medical devices across 37 medical fields, each categorized based on their risk level.

Types of Medical Devices:

Notified Devices: These are regulated under the Medical Devices Rules, 2017, by CDSCO.
Non-Notified Devices: These devices are not listed as notified in the official gazette by the Government of India.

Risk-Based Classification of Medical Devices Under CDSCO Directive:

Class A: No pre-inspection required; SLA issues the license on Form MD-5.
Class B: Requires inspection by a notified body; SLA issues the license on Form MD-5.
Class C: Inspection by CDSCO officers required; CLA issues the license on Form MD-9

Conclusion

CDSCO is committed to ensuring transparency, accountability, and uniformity in its services to guarantee the safety, efficacy, and quality of medical products manufactured, imported, and distributed in India. Its mission is to protect and enhance public health by ensuring the quality and safety of medical devices.

Frequently asked questions (FAQ)

What is CDSCO?

CDSCO, or the Central Drugs Standard Control Organisation, is India's national regulatory authority responsible for overseeing the regulation of drugs, medical devices, and cosmetics.

Who Regulates Pharmaceuticals and Medical Devices Within CDSCO?

The Drug Controller General of India (DCGI) is responsible for regulating pharmaceuticals and medical devices within the Central Drugs Standard Control Organisation (CDSCO) and operates under the Ministry of Health and Family Welfare.

What Are Notified Devices?

Notified Devices are those that fall under the Medical Device Rules, 2017, as regulated by CDSCO.

What Are the Categories of Medical Devices?

Medical Devices are classified into two main types: Notified and Non-Notified Devices. They are further categorized into four risk-based classes—A, B, C, and D—based on their level of risk.