INDIA

Regulatory Authority

The Indian medical device market is regulated by the Central Drugs Standard Control Organization (CDSCO).

India Medical Device Regulations & Guidance:

• Drugs and Cosmetics Act, 1940: Historically, medical devices have been regulated under this act. Drugs and Cosmetics Act, 1940.

• Medical Devices Rules, 2017 :Specific regulations for medical devices. Medical Devices Rules, 2017.

Indian Medical Device Classifications :

Medical devices in India are classified into four classes:

• Class A : Low risk.
• Class B : Low to medium risk.
• Class C : Medium to high risk.
• Class D : High risk.

Medical Device Market Requirements in India :

• Registration and Licensing : All medical devices require registration and licensing.
• Clinical Trial : Required for certain device classes. Guidance on clinical trials in India.

Post-Market Requirements for Medical Devices in India :

• Monitoring and Reporting : Manufacturers must monitor device performance and report any serious incidents. CDSCO Post-Market Surveillance.

UDI Requirements :

• Implementation in Progress : India is in the process of implementing UDI requirements for medical devices.

Standards and Essential Requirements in India :

• Quality and Safety Standards : Manufacturers must adhere to specific standards, often resembling ISO and IEC standards. CDSCO Recognized Standards.

How Medfins International Will Help :

At Medfins International, we are dedicated to guiding you through the complexities of India’s medical device market. Our experts are well-versed in the regulations set forth by the Central Drugs Standard Control Organization (CDSCO) and offer comprehensive support at every stage, from device classification to market authorization and post-market requirements.

• Tailored Regulatory Strategy : We develop customized strategies to ensure your medical devices comply with all pertinent regulations under the Medical Devices Rules, 2017, aiming to minimize the risk of market entry delays in India.
• Compliance and Submission Support: Our team provides assistance in preparing and submitting essential documentation for registration and licensing with CDSCO, ensuring strict adherence to India’s rigorous standards.
• Post-Market Surveillance Guidance: We offer advice on establishing effective post-market surveillance systems in compliance with CDSCO mandates, crucial for maintaining market presence and ensuring patient safety.
• Ongoing Regulatory Support: Stay informed of regulatory changes with our continuous monitoring and advisory services, ensuring your sustained compliance with Indian medical device regulations.