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SOFTWARE AS A MEDICAL DEVICE – REGULATORY COMPLIANCES

  • July 16, 2023
  • KngTechLaw
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      INTRODUCTION The company has developed software medical devices that are supported by AI, with their flagship products being SYmpi and CIE, which cater to the needs of both patients and doctors. They have already received the testing licensing from CDSCO, and are now looking to acquire further clinical trials and other licenses. […]

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  • Recent Updates in India’s Medical Device Regulation in India and IVD Regulatory Landscape — CDSCO Latest Circulars & Compliance Advisory
    June 2, 2026
  • Notification on Prohibited Drugs: Nimesulide, Chloramphenicol, and Nitrofurans — A Drug Law Advisory Under Drugs and Cosmetics Rules Legal Advisory
    June 1, 2026
  • Indian Pharmaceutical Policy Landscape: A Pharmaceutical Law Firm India and Health Care Law Guide
    June 1, 2026
  • Compliance and Risk Management in Indian Pharma & MedTech: A Health Care Law and CDSCO Regulatory Lawyer India Perspective
    June 1, 2026

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14 FDCs prohibited. 2016 2023 Accessibility Guidelines Across Health Sector for Persons with Disabilities ADVISORY ON DIGITAL PRESCRIPTION Artificial Intelligence in Healthcare Industry: ICMR Guidelines COMPLIANCE FOR WHOLESALERS AND PACKERS UNDER LEGAL METROLOGY (PACKAGED COMMODITY) RULES 2011 Compliance Requirements for Single-Use Plastic Guidelines Dark Patterns Compliance DATA PROTECTION BILL COMPLIANCE Don’t Miss the Bus - EBA Guidelines and compulsory implementation E-commerce Guidelines ON ONDC ESG E SHOP SHIPING CHARGE ON SALE OF DRUGS HIV Testing Laws and Compliances KEY FEATURES OF THE RIGHTS OF PERSONS WITH DISABILITIES ACT Legal Article on Advertisement of drugs MEIT REPORT OF COMMITTEE - B ON LEVERAGING AI FOR IDENTIFYING NATIONAL MISSIONS IN KEY SECTORS OTC Drugs Patent PLANNING TO INTRODUCE SEXUAL WELLNESS TOYS Privacy Policy Recommendations for E-Pharmacy Promotion of Drugs in India QR CODE AND ANTI-COUNTERFEIT MEASURES Registration of Medical Practitioners and Licence to Practice Medicine Regulations REPACKING OF DRUGS SOFTWARE AS A MEDICAL DEVICE - REGULATORY COMPLIANCES The sale of H1 Drugs by E-pharmacy site on the basis of a Narcotics License Track & Trace for Pharmaceutical Products compliance Uniform Code for Medical Device Marketing Practices Voluntary Code of Conduct for E-Pharmacies in India Whether one can sell and deliver cut-strip medicine in India?
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