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The Central Drugs Standard Control Organisation (CDSCO) has listed out around 1,700 standards published under the Medical Equipment and Hospital Planning (MHD) of the Bureau of Indian Standards (BIS) so far, in an effort to help the industry to comply with the standards for their specific products.
The list, in around 20 categories, details the IS numbers of the medical devices and equipment which are used in the daily services offered by the hospitals in the country.
This include 123 standards for surgical instruments, 170 standards for orthopaedic instruments, implants and accessories, 78 standards for obstetric and gynaecological instruments and appliances, 83 standards for ear, nose, throat and head & neck surgery (ENT-H&N) instruments, 115 standards for ophthalmic instruments and appliances, 72 standards for medical and surgical cardiology equipment, 38 standards for neurosurgery instruments implants and accessories, 235 standards for dentistry, and 155 standards for assistive products including rehabilitation appliances, orthotic and prosthetic items.
Besides, 30 standards for medical laboratory instruments, 80 standards for anaesthetic, resuscitation and allied equipment, 181 standards for hospital equipment and surgical disposable products, 21 standards for veterinary hospital planning and surgical instruments, 61 standards for hospital planning, 107 standards for electromedical, diagnostic, imaging and radiotherapy equipment, and 121 standards for health informatics were also published by the BIS so far.
Apart from this, 50 standards for in-vitro diagnostic medical devices and biological evaluation of medical devices, 24 standards for medical biotechnology and medical nanotechnology, three standards for hospital biomedical waste management and infection control, and 13 standards for anatomy and forensic sciences equipment are also listed by the BIS.
The Rule 7 of the Medical Devices Rules, 2017 states that the medical device shall conform to the standards laid down by the BIS established under section 3 of the Bureau of Indian Standards Act, 1985 (63 of 1985) or as may be notified by the ministry of health and family welfare in the Central government, from time to time.
According to the BIS, the Medical Equipment and Hospital Planning Division Council (MHDC) of the Bureau deals with standardisation in the field of medical equipment, surgical dressings, artificial limbs, rehabilitation equipment, diagnostic kits, veterinary surgery instruments, dental equipment, laboratory instruments and equipment, hospital biomedical waste management and infection, control, medical biotechnology and medical nano-technology, hospital planning and health care service, biological and clinical evolution of medical device, Immuno-biological diagnostic kits and medical electrical equipment.
The council has been working towards national standardisation of medical devices and equipment, to provide a framework for the development of Indian standards to support the regulatory framework in the country for medical devices, and to provide a platform for enabling the domestic industry to be able to compete at international levels through harmonization with international standards and adoption of best standardization practices, among other objectives.
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