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English: These Regulations contain the legislative measures necessary for the implementation of three European Community Directives- Council Directive 90-385-EEC on the approximation of the laws of the Member States relating to active implantable medical devices, as amended; Council Directive 93-42-EEC concerning medical devices, as amended; and Directive 98-79-EC of the European Parliament ...
The Insurance Regulatory and Development Authority of India (IRDAI) is an autonomous [1] and statutory body under the jurisdiction of Ministry of Finance, Government of India. It is tasked with regulating and licensing the insurance and re-insurance industries in India. [ 2 ]
ISO 14155 Clinical investigation of medical devices for human subjects -- Good clinical practice. This international standard addresses good clinical practices for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety and performance of medical devices for regulatory purposes.
The Insurance Repository in India is a database of insurance policies.It allows policy holders to make revisions to a policy. It launched on 16 September 2013. It is the world's first of its kind.
The Global Harmonization Task Force (GHTF) was “a voluntary group of representatives from national medical device regulatory authorities (such as the U.S. Food and Drug Administration (FDA)) and the members of the medical device industry” [1] whose goal was the standardization of medical device regulation across the world.
Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
List is arranged chronologically based on their recognition by IRDAI # Company Sector Headquarters Founded 1: Life Insurance Corporation of India: Govt. Mumbai: 1956 2: HDFC Life Insurance Co. Ltd. Private Mumbai: 2000 3: Axis Max Life Insurance Co. Ltd. Private Delhi: 2000 4: ICICI Prudential Life Insurance Co. Ltd. Private Mumbai: 2000 5 ...
A design history file is a compilation of documentation that describes the design history of a finished medical device.The design history file, or DHF, is part of regulation introduced in 1990 when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for medical devices that can cause or contribute to the death, serious illness, or injury of a patient.