Regulatory Landscape and Quality Standards for Orthopedic Devices in India
India’s regulatory framework for orthopedic devices is evolving to ensure safety, efficacy, and quality compliance. The India Orthopedics Market report outlines recent reforms and standards shaping the orthopedic device market.
Orthopedic implants are regulated under the Medical Device Rules (MDR) 2017, which classify devices based on risk and mandate registration, clinical evaluation, and quality certifications. The Central Drugs Standard Control Organization (CDSCO) oversees approvals.
International standards such as ISO 13485 are increasingly adopted by manufacturers to meet global benchmarks. Quality control, post-market surveillance, and vigilance reporting are emphasized to prevent adverse events.
The government is streamlining device approvals and encouraging domestic manufacturing under the Make in India initiative, promoting innovation and reducing dependence on imports.
Compliance with robust regulatory and quality standards fosters patient safety and strengthens India’s position as a global orthopedic device supplier.