The Indian healthcare industry is a fast-growing sector expected to reach $280 billion by 2025. Further, India ranks among the top 20 medical device markets in the world. With such growth on the horizon, effective regulation of medical devices is a must.
Historically, this sector has been largely unsupervised. However, the government has enacted certain laws and regulations to streamline the production and distribution of medical devices.
Here, we discuss everything you need to know about regulatory compliance for medical devices.
Regulatory Compliance for Medical Devices in India
Medical device regulations in India are administered by the Central Drugs Standard Control Organisation (CDSCO) under the supervision of the Directorate General of Health Services in the Ministry of Health & Family Welfare.
As India’s National Regulatory Authority (NRA), the CDSCO oversees the production and distribution of medical devices. Non-local companies that want to register their medical devices in India must appoint a local manufacturer or agent to ensure compliance with Indian regulations.
Medical Device Regulations in India
The laws and regulations that govern medical devices in India include:
- The Drugs and Cosmetics Act, 1940
- Medical Devices Rules, 2017
Manufacturers, distributors, and medical institutions must follow the provisions mentioned in the above laws to avoid legal issues.
Medical Device Classification in India
Medical devices in India are divided into five categories based on their risk level: A (non-standard and non-measuring /non-sterile), A (measuring/sterile), B, C, and D.
The CDSCO application fees may vary depending on the medical device’s category. The application process for all categories except Class A (non-measuring/non-sterile) can take six to nine months. Class A (non-measuring/non-sterile) process is quicker. Lastly, medical devices that don’t fit into any category will be identified as ‘innovative,’ and their application process may take more than nine months.
To Sum Up
In conclusion, regulatory compliance for medical devices in India is crucial for ensuring patient safety and maintaining industry standards.
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REFERENCES
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8815674/
https://asiaactual.com/india/medical-device-registration/#:~:text=Medical%20Device%20regulations%20in%20India,Authority%20(NRA)%20of%20India.
https://www.tuvsud.com/en-in/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-market-approval-and-certification/regulation-of-medical-devices-in-india
https://reciprocity.com/blog/regulatory-compliance-in-healthcare/
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