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By G.R Higson

Scientific gadget protection: The law of scientific units for Public wellbeing and fitness and defense examines the customers for attaining worldwide harmonization in clinical machine legislation and describes a potential destiny worldwide process. Unresolved problems are mentioned whereas recommendations are proposed. a vital ebook for all these keen on future health physics, engineering, and clinical regulatory affairs.

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Extra info for Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety

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It was originally formed as an association of a small number of manufacturers of implanted cardiac pacemakers and later expanded to include manufacturers of other long-term implantable devices. Its membership never exceeded twenty but the well-defined sphere of interest and the direct involvement of its members made it very influential. 26 The transformation in the European Community Each of these associations responded in some way to the opportunity presented by the 1992 programme and the New Approach.

The labelling requirements were laid down, and products had to be released on to the market by an Industrial Pharmacist registered with the Ministry of Health. This Decree was followed by the Law on Medicines of 25 March 1964 (Belgium 64) (as amended by the laws of 16 June 1970, 21 June 1983, 22 December 1989 and 16 July 1990). This law had enabling clauses which allowed it to be applied to almost everything that would now be regarded as a medical device. In practice, these powers were rarely used.

They were to be tested by, or under the supervision of, the National Centre for Pharmacobiology with respect to detailed physical, chemical and biological characteristics. These testing requirements were not appropriate for all implants and the testing facilities were not adequate. As a result, virtually no implants were approved in Spain but they were allowed into use by means of an ‘exceptional import approval’. This was generally granted if a satisfactory application for pre-market approval had been made and a certificate of compliance from the country of origin was available; contraceptive devices which were subject to control and inspection by the Ministry of Health; homologation procedures which applied to a range of home-use products which could be provided under the social security system only if they had been certified as complying with requirements, and to several categories of electromedical equipment.

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