Indian Medical Devices Regulation Transform : All Medical Device will be brought under regulation
At the 9th International Pharmaceutical Exhibition (iPHEX), the Drugs Controller General of India (DCGI), Rajeev Singh Raghuvanshi, announced that Group C and D medical devices will be brought under regulation by October 1. The move aims to ensure quality and safety standards in the production of medical devices.
Previously, the government regulated the A and B groups.
Read about CDSCO medical device classification.
India’s medical device industry is valued at USD 11 billion, with the Indian government making efforts to maintain growth and empower businesses through regulatory measures.
The upcoming Indian Medical Devices Regulation for all medical device is part of the approved National Medical Devices Policy, 2023, by the Union Cabinet, will significantly impact the Indian medical devices sector. By enforcing comprehensive quality controls, the regulations aim for Class C and D High Risk medical Devices to enhance India’s position in the global medical device market.
The announcement was made at iPHEX, where industry leaders highlighted the remarkable progress of the Indian pharmaceutical industry. In the previous fiscal year, Indian pharmaceutical exports reached USD 25.39 billion, with a target of USD 28 billion for the current fiscal year.
The sector is expected to witness growth with improved standards, enhanced product quality, and increased consumer confidence. This achievement showcases India’s commitment to healthcare excellence and establishes the country as a key player in the global medical device industry.
Contact us today to ensure regulatory compliance for your medical device manufacturing. Our team of experienced medical device regulatory consultants is ready to guide you through the process and help you meet the quality and safety standards set by the authorities. Let us support your journey towards successful and compliant medical device production.
Referance: https://www.medicalbuyer.co.in/india-to-regulate-all-medical-devices-from-october-1/
