Introduction
In India, all medical devices now come under the scope of the Drugs and Cosmetics Act, 1940. This change follows the Medical Devices (Amendment) Rules, 2020, effective from April 1, 2020. The amendment brought every medical device, whether notified earlier or not, under strict regulatory control. It ensures quality, safety, and compliance in line with international standards.
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What Is The Definition of Medical Devices
The amendment expanded the definition of medical devices. It includes any instrument, apparatus, implant, software, or accessory for humans or animals. These devices may be used for diagnosis, treatment, prevention, monitoring, or supporting life. The rule applies as long as the device does not act primarily through pharmacological, immunological, or metabolic means.
Before 2020, only 37 categories of devices were regulated. From April 1, 2020, all medical devices, whether previously notified or not, must follow the Medical Devices Rules, 2017 (MDR). This created uniform oversight and eliminated regulatory gaps in the sector.
What Are The Registration Requirements for Manufacturers and Importers
Manufacturers and importers of devices that were not regulated before February 11, 2020, must register with the Drugs Controller General of India (DCGI). The deadline for registration was October 1, 2021. Registration is mandatory before applying for a license.
Is There An Exemption for Previously Notified Devices
The 37 categories already under regulation before February 11, 2020, are exempt from the new registration requirement. However, they must still follow all MDR quality, licensing, and safety standards.
What Are The Licensing Deadlines for Newly Regulated Devices
Licensing for newly covered devices follows a phased timeline:
Registration for all unregulated devices: October 1, 2021.
License requirement for Class C (medium-high risk) and Class D (high risk) devices: October 1, 2023.
Quality Management Standard
Every registration application must prove compliance with ISO 13485, the international quality management system for medical devices. This ensures manufacturing processes meet global safety and performance benchmarks.
The Central Drugs Standard Control Organisation (CDSCO) remains the licensing and enforcement authority. It operates a dedicated online registration portal to streamline applications and compliance monitoring.
What Are The Penalties for Violation
Selling, distributing, or importing medical devices without proper registration or license after the deadlines is illegal. Violators face criminal prosecution, which may include imprisonment and heavy fines.
What Is The Risk-Based Classification System
The amendment applied the risk-based classification from the MDR to all devices:
1. Class A – Low risk
2. Class B – Low-moderate risk
3. Class C – Moderate-high risk
4. Class D – High risk
This classification aligns with global regulatory systems, including the EU, US, Canada, Australia, and Japan.
The DCGI and CDSCO have the authority to revise classifications, change standards, and update the official classification list based on new technology or safety concerns.
Conclusion
The Medical Devices (Amendment) Rules, 2020 transformed medical device regulation in India. By bringing all devices under the Drugs and Cosmetics Act, the government established a uniform, risk-based, and globally aligned regulatory system. This ensures that every medical device under the Drugs and Cosmetics Act in the Indian market meets strict safety, quality, and performance standards, protecting both patients and healthcare providers.
