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Implementation of Indian Standards on Medical Devices




Our Ref: MHD/O-5.1                                                                        Date: 24.02.2016

Subject: Implementation of Indian Standards on Medical Devices - regards


Drug Controller(s) of State Governments of Union of India.

Dear Sir(s)/Madam,

As you may be aware that Bureau of Indian Standards (BIS) enacted by the act of parliament under the Bureau of Indian Standards Act, 1986 is a National Standards Body of India working under the aegis of Ministry of Consumer Affairs, Food & Public Distribution, Govt. of India.

The Bureau establishes Indian Standards in relation to any article or process and amend, revise or cancel the standards so established as may be necessary, by a process of consultation with consumers, manufacturers, technologists, scientists and officials through duly constituted committees. All the Indian Standards are established by notification in the Official Gazette of Govt. of India.

Medical Equipment & Hospital Planning Division Council (MHDC) is one of the important Technical Councils under the Chairmanship of Dr. B D Athani, Special DG (DGHS), Ministry of Health & Family Welfare (MoHFW). There are 19 Technical Committees under MHDC engaged in the formulation of Indian Standards in the subject area. Various technical committees of Medical Equipment & Hospital Planning Department (MHD) are engaged in formulation of Indian Standards on Medical Devices.

All the standards are dynamic and are periodically reviewed to assess their continued suitability and updating with the latest development in the respective field. The current list of Indian Standards published on Medical Devices is enclosed for your ready reference.

We would request you to please refer these standards for ensuring quality of medical devices for protecting the interest of all concerned and public at large. We would appreciate if compliance to these standards are referred to in your procurement policies, and purchase specifications/tenders including general guidelines for health care services as well as healthcare manufacturers. Further, whenever regulatory requirements, reference may be made to National Standards. In this regard, special attention is invited to IS/ISO 13485:2003 ‘Medical devices — Quality management systems — Requirements for regulatory purposes’, against which BIS is intending to launch Quality Management System Certification Scheme shortly on the same lines as being done in case of other management  system certifications like IS/ISO 9001‘Quality management systems – Requirements’, IS/ISO 14001 ‘Environmental management systems -- Requirements with guidance for use’, IS 15700 ‘Quality management systems — Requirements for service quality by public service organizations’, etc.

Thanking You,

Yours faithfully,

Encl: As above

(Dileep Kumar)

Sc ‘F’ & Head (MHD)