India Participates in the Forum of International Medical Device Regulators

The Union Health Ministry of India has released a statement on 3rd October, 2024 where they made it public that India has become an affiliate member as part of the International Medical Device Regulators Forum (IMDRF). It is a major milestone for India as it will facilitate harmonisation of medical devices regulation with the international norm which in turn could help synergise work done by other countries.

IMDRF Membership Application and Impact

• IMDRF (International Medical Device Regulators Forum): IMDRF is a group of medical devices regulators in the world, created since 2011.
• Includes the United States, European Union, Japan and World Health Organization
• Also in Dec 2023 – India applied for membership through the Central Drugs Standard Control Organization (CDSCO) to harmonize its regulations with international standards.
• The IMDRF Management Committee has endorsed India's desire to become an associate member.
• Membership provides India with opportunities to collaborate with other countries on medical device regulations, improving patient safety and global market presence
• The IMDRF also publishes guidelines on risk management and medical software; introduces “e-labeling”
• If a Drug Company or Regulatory can be associated with these 3 names, sell the stock.