Health Ministry Proposes Amendments to Medical Devices Rules, 2017 to Streamline Licensing

📌 Summary:

• MoHFW published a draft Gazette notification proposing amendments to the Medical Devices Rules, 2017 to simplify and speed up manufacturing-licence approvals while maintaining quality, safety and performance standards
• Medical devices are classified into four risk categories — Class A, B, C and D (Class D = highest risk)
• Class B (e.g., BP monitors, hypodermic needles, pulse oximeters): manufacturing-licence timeline cut from 140 to 115 days
• Class C and D (e.g., cardiac stents, hip/knee implants): timeline cut from 105 to 90 days
• Introduces clearly defined timelines for each stage — application scrutiny, audit by notified bodies, compliance verification, licence issuance — for transparency and predictability
• Aim: enhance ease of doing business and timely availability of quality devices; draft open for stakeholder comments via CDSCO / Official Gazette

🎯 UPSC Relevance: GS3 (S&T — health-technology regulation; ease of doing business) and GS2 (governance — regulatory reform balancing speed with safety).

📝 Prelims Facts:

• Medical Devices Rules, 2017; regulator = CDSCO (Central Drugs Standard Control Organisation)
• Risk classes: A, B, C, D (D highest)
• Class B: 140 → 115 days; Class C/D: 105 → 90 days

🔑 Key Term: CDSCO — India's national regulatory authority for drugs, cosmetics and medical devices, under the Ministry of Health and Family Welfare.