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based on their top general quality, mainly their scientific value and suitability to internet browsing.
Medical Plastics Data Service, has been selected as one of Biomat.net's Top 5 sites
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Government preparing to introduce GMP for medical devices
The Government may soon come out with a set of Good Manufacturing Practice (GMP) norms for regulating manufacture and imports of medical devices used in the clinical as well as therapeutic areas in the country. The norms, which are recommended by the regulatory committee constituted last year for preparing a draft of code for approval of medical devices, would most likely replace the schedule M (2) of the Drugs and Cosmetics Act.
The committee report which was submitted recently to the Union Ministry of Health through the Drug Controller General of India, has listed out around 1800 products classifying into different groups by which the manufacturing and quality standards, the regulations, testing and analysis have been defined.
The committee had identified the medical devices to be put under regulatory control in the order of very critical, critical and semi-critical.
Broadly, these products include the electronic as well as mechanical devices made of plastic as well as metals, which are used within the body and externally for medical and therapeutical application.
The proposed regulatory framework will put all the medical devices including hearing aids, patches, straps, electronic massaging devices, inhalers, etc. used for healing under regulatory mechanism.
[Ref: Sept. 16-30, 2003]
Sree Chitra Tirunal Institute cleared for ISO 170025 Certification
Sree Chitra Tirunal Institute for Medical Sciences & Technology Thiruvananthapuram, an autonomous institution under the Department of Science and Technology (DST), has been cleared for the coveted ISO 170025 (a certification for medical devices) certification.
A team of experts from the French National Agency that made a visit to the institution recently is known to have highly recommended for the certification, which would place the institute among the best medical device testing institutions in the world.
According to Secretary, DST, the inspection team was surprised to find the international quality of the institution and has immediately recommended for the certification. The official announcement of the recognition is to come within a month.
The certification has paved way for the institute to test, evaluate and certify the quality of foreign medical devices and equipment. The stamp of approval from the institute is to be recognised even in the developed world. Sree Chitra Institute is the only institution of its kind that has been cleared for such an approval in India.
[Ref: PBHR, 16/07/03]
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