Last Updated on August 10, 2024 by The Health Master
Medical Devices
In a move that could significantly expedite the availability of cutting-edge medical technology in India, the government is considering eliminating the requirement for clinical trials for medical devices already approved by the European Union (EU).
This potential policy change aims to streamline the regulatory process and bring advanced healthcare solutions to Indian patients more quickly.
Currently, India already grants exemptions from clinical trials for medical devices cleared by regulatory authorities in the United States, United Kingdom, Australia, Canada, and Japan.
The inclusion of the EU in this list is now on the agenda for the next meeting of the Drugs Technical Authority Board (DTAB), India’s highest drug advisory body.
If approved, this change will require an amendment to Rule 63(1) of the Medical Devices Rules, 2017.
This development comes after years of deliberation, with the initial proposal dating back to 2018.
While the healthcare ministry has shown interest in expediting the process, it has also emphasized the need for a thorough review of the potential implications.
Industry Seeks Reciprocity, Not One-Sided Benefits
However, not everyone is enthusiastic about this proposed change.
Rajiv Nath, forum coordinator of the Association of Indian Medical Devices Industry, has raised concerns about the potential for a one-sided advantage.
Nath argues that India should seek reciprocal benefits from the EU, such as faster approval processes for Indian-made medical devices.
He suggests that a mutual recognition agreement (MRA) between the two regions could be a more balanced approach.
Key Takeaways:
- India is considering waiving clinical trials for EU-approved medical devices to accelerate their availability.
- This move could potentially improve patient access to advanced healthcare.
- The industry is advocating for a reciprocal arrangement with the EU to ensure fair competition.
- The final decision will be made by the Drugs Technical Authority Board (DTAB).
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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