The Central Drugs Standard Control Organisation (CDSCO) has released a comprehensive list of around 1,700 standards developed under the Medical Equipment and Hospital Planning Division (MHD) of the Bureau of Indian Standards (BIS). The move aims to help the medical device industry align their products with established national standards and ensure better regulatory compliance.

The list, covering around 20 categories, specifies the Indian Standard (IS) numbers for a wide range of medical devices and hospital equipment used in routine healthcare services across India.

It includes 123 standards for surgical instruments, 170 for orthopaedic instruments, implants and accessories, 78 for obstetric and gynaecological devices, 83 for ear, nose, throat and head & neck (ENT-H&N) instruments, 115 for ophthalmic equipment, 72 for cardiology devices, 38 for neurosurgery instruments, 235 for dentistry, and 155 for assistive and rehabilitation products such as orthotic and prosthetic items.

Additionally, BIS has published 30 standards for medical laboratory instruments, 80 for anaesthetic and resuscitation equipment, 181 for hospital and disposable products, 21 for veterinary hospital planning and instruments, 61 for hospital planning, 107 for electromedical, diagnostic, imaging and radiotherapy equipment, and 121 for health informatics.

The list also includes 50 standards covering in-vitro diagnostic devices and biological evaluation of medical devices, 24 for medical biotechnology and nanotechnology, three for biomedical waste management and infection control, and 13 for anatomy and forensic sciences equipment.

Under Rule 7 of the Medical Devices Rules, 2017, all medical devices must conform to BIS standards established under the Bureau of Indian Standards Act, 1985, or as notified by the Ministry of Health and Family Welfare from time to time.

According to BIS, the Medical Equipment and Hospital Planning Division Council (MHDC) oversees standardisation across medical equipment, surgical dressings, artificial limbs, diagnostic kits, dental and laboratory instruments, biomedical waste management, medical biotechnology, nanotechnology, hospital planning, and health informatics.

The council’s efforts are focused on establishing a strong national framework for medical device standardisation, supporting the country’s regulatory system, and enabling Indian manufacturers to compete globally through harmonisation with international benchmarks and adoption of best standardisation practices.