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The regulation of medical devices and the role of the Medical Devices Agency
This article reviews the regulation of medical devices in the UK and Europe and compares the regulatory regime with that for pharmaceuticals. The regulation of devices follows the ‘New Approach’ policy of the EC Commission and involves more self-regulation and conformity assessment. The controls are...
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| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
Blackwell Science Inc
2001
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| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC2014554/ https://ncbi.nlm.nih.gov/pubmed/11560554 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1046/j.0306-5251.2001.01416.x |
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