On July 31st, members of AMCHAM’s Medical Device Committee convened a strategic meeting of healthcare experts specializing in government affairs to discuss key policy and regulatory developments impacting the medical technology sector. The meeting was led by committee government affairs representatives – Ms. Jyotsna Ghoshal, Johnson & Johnson, Mr. Ravi Valia, India Medtronic, Mr. Sudhakar Mairpadi, BD and Ms. Shobha Mishra Ghosh, GE Healthcare – who provided valuable insights and updates on the following topics:

1. Uniform Code for Marketing Practices in Medical Devices (UCMPMD) 2024
   • The Department of Pharmaceuticals (DoP) recently held consultations with a limited group of medical device associations to discuss implementation of the UCMPMD.
   • Updates were shared on the proposed format for self-declaration and marketing compliance. DoP advised these associations to collect and manage this data until a central portal is operational.
   • A formal notification extending the submission deadline is expected shortly.
   • At this stage, no immediate advocacy action is required from AMCHAM.
2. Global Tender Enquiry (GTE) Policy
   • Associations have submitted revised lists of medical devices under GTE for consideration by the DoP.
   • The government is prioritizing the pharma list, while the finalization of the medical devices list is expected to follow.
   • Stakeholder inputs are being actively gathered, including from procurement agencies.
   • AMCHAM will engage with the following key government officials better understand the review process and timelines: Mr. R.P. Singh, Joint Secretary, DoP, Ms. Palka Sahni, Joint Secretary, DoP and Directorate General of Health Services (DGHS)
3. Government e-Marketplace (GeM) Portal
   • Members shared concerns about challenges in the vendor assessment process on the GeM Portal.
   • Since it is a cross sectoral issue, no sector-specific intervention from AMCHAM is required at this time.