News/Updates

The New Medical Devices Bill, 2023, has ignited a storm of controversy within the Indian medical device industry. As the debate intensifies, experts are sounding the alarm about potential pitfalls and ramifications that could jeopardize Prime Minister Narendra Modi’s ambitious ‘Make in India’ campaign.  Criticisms Highlight Bill’s Disconnection from Reality Rajiv Nath, a prominent figure […]

Safer Sterilisation Guidelines for Medical Devices from the FDA Food and Drug Administration (FDA) recently recognized new medical device sterilization standards as an alternative to the use of ethylene oxide (EtO). Ethylene oxide is a commonly used method for sterilizing medical devices, but there have been regulatory efforts by the US Environmental Protection Agency (EPA)

India’s Remarkable Surge: 16.15% Growth in Medical Device Exports India has still 75% import dependency on medical devices. To encourage investments in manufacturing of medical devices, Indian Government announced incentivisation plans of US$ 4.9 billion in five years. This fund will be offered to manufacturers only if they invest in setups to manufacture key medical

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

Testing Labs for Medical Devices – Latest News The Health Ministry issued a final notification revising the MDR, 2017. It has introduced new sub-rules that define the establishment of state medical device testing laboratories. Operon Strategist stays on top of all the recent medical device industry updates. Subscribe to our Newsletter for all the updates.

Operon strategist is thrilled to share exciting news for MedTech companies in the US. Medical device manufacturers can seek funding of up to $300,000 through the Advanced Manufacturing Clearing House program (AMCH). The Medical Device Innovation Consortium (MDIC) in partnership with the FDA has come up with a program – AMCH to expedite the adoption

Operon Strategist stays on top of the latest developments in medical devices. Sharing another important and recent update: The Department of Consumer Affairs has sent a letter to the Department of Pharmaceuticals (DOP) requesting that medical devices must include key details on the package.  “All medical devices will have to bear details like retail price,

As a medical device consultancy, we are pleased to share a significant announcement made by the Department of Pharmaceuticals (DoP), Ministry of Chemicals & Fertilizers, Govt. Of India. The DoP recently announced the scheme for “Assistance to Medical Device Clusters for Common Facilities (AMD-CF)”. Niti Aayog and the DoP had identified a few factors that

Operon Strategist, a leading medical device consultancy, is excited to share the recent developments in the Indian medical devices sector as conveyed by Dr. Mansukh Mandaviya, the Union Minister of Health & Family Welfare.   He emphasized the importance of the medical devices sector in India’s healthcare system. Dr. Mandaviya stated that the Indian medical devices

Government Approves National Medical Device Policy 2023  The Indian Cabinet has approved the National Medical Devices Policy 2023, which aims for the growth of the medical devices sector in India. The policy’s six strategies aim to tap into the potential of the sector, and its implementation plan is expected to help the sector grow from its