News/Updates

FDA Draft on PCCPs for Medical Devices The U.S. Food and Drug Administration (FDA) has issued a draft guidance document for its proposed policies for predetermined change control plans (PCCPs) for medical devices. The guidance provides the FDA’s current thinking and recommendations on the information to include in a PCCP in a marketing submission for […]

20% Capital Subsidy for Domestic MedTech Component Production NEW DELHI: The government plans to launch a new scheme to incentivize the MedTech or medical technology industry to manufacture components for digital X-ray, CT scan, and MRI machines in the country. Currently, most such components are imported leading to the high cost of the devices and,

Mandatory BIS Certification for Medical Textile Products The Bureau of Indian Standards (BIS), India’s national standards body functioning under the Ministry of Consumer Affairs, Food and Public Distribution, plays a crucial role in maintaining quality and safety across various industries. BIS administers numerous schemes, including Product Certification (ISI mark), Management Systems Certification, Hall Marking of

New Scheme for Domestic Medical Device Industry A new scheme aimed at strengthening the domestic medical device industry will be rolled out within the next month, Department of Pharmaceuticals Secretary Arunish Chawla announced on Wednesday. The scheme, formulated after extensive consultations with the medical device industry, was discussed during an event here. “This scheme will

India’s First Center of Excellence in Medical Devices Varanasi: The Indian Institute of Technology (BHU) Varanasi is set to establish the country’s first Center of Excellence (CoE) in Medical Devices, bringing together the production of medical devices and equipment under one roof. This pioneering initiative will primarily focus on E-mobility and biomedical devices. IIT BHU

According to persons familiar with the topic, the administration is considering eliminating the necessity for clinical evaluation of devices approved in the European Union (EU) to accelerate the availability of innovative medical devices in the country. So far, the government has exempted clinical investigation requirements in cases when regulatory agencies in the United States, United

Indian Medical Device Industry Demands Higher Duty and Lower GST: The Indian medical device industry wants a significant hike in customs tax on medical imports as well as a reduction in GST in the Budget 2022-23. It is encouraging the government to boost basic customs duty on medical device imports to 15%, up from the

Focus on Local Affordable Medical Device Manufacturing In a significant move to cut down import dependence, the government has announced plans to promote the local manufacturing of 113 affordable medical devices over the next five years. This initiative aims to leverage the country’s existing strengths by supporting both Indian companies and multinational corporations with manufacturing

AI Act Published in Official Journal of the EU: Harmonized Rules for AI Systems July 12, 2024 – The Artificial Intelligence Regulation (AI Act), officially Regulation (EU) 2024/1689, has been published in the Official Journal of the European Union. This landmark regulation establishes harmonized rules for the development, market placement, service deployment, and use of

Extension of IVDR Transitional Period The Regulation (EU) 2024/1860, which amends Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR), has been published in the Official Journal of the European Union (OJEU). This legislation aims to ensure the continuity of supply for in vitro diagnostic devices on the European market. It also revises provisions related to