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  2. Medical Device Regulation Act - Wikipedia

    en.wikipedia.org/wiki/Medical_Device_Regulation_Act

    Manufacturers and importers are to prepare for the application of such requirements and to report medical devices intended for human use manufactured or imported by them. Panel appointments shall consist of members with adequately diversified expertise in such fields as biological and physical sciences, clinical and administrative medicine ...

  3. Custom-made medical device - Wikipedia

    en.wikipedia.org/wiki/Custom-made_medical_device

    Jurisdiction Definition Legislation Australia A medical device that: (a) is made specifically in accordance with a request by a health professional specifying the design characteristics or construction of the medical device; and (b) is intended: (i) to be used only in relation to a particular individual; or (ii) to be used by the health professional to meet special needs arising in the course ...

  4. Andhra Pradesh Medtech Zone - Wikipedia

    en.wikipedia.org/wiki/Andhra_Pradesh_Medtech_Zone

    The CMIT team acts as knowledge repository for export and import data on medical devices and an advisory board on all matters relating to medical device sector. This cell also tracks foreign direct investments via different routes in the Indian medical device ecosystem and gives strategical recommendations to various incubated start-ups at AMTZ ...

  5. Frank Baylis - Wikipedia

    en.wikipedia.org/wiki/Frank_Baylis

    Frank Baylis' mother, Gloria Baylis, a nurse by profession, founded Baylis Medical Company in the early 1980s, running the business out of the family home. [15] In 1986 Baylis Medical was incorporated as an importer and distributor of medical devices. [15]

  6. Medical device reporting - Wikipedia

    en.wikipedia.org/wiki/Medical_device_reporting

    Medical device reporting (MDR) is the procedure for the Food and Drug Administration to get significant medical device adverse events information from manufacturers, importers and user facilities, so these issues can be detected and corrected quickly, and the same lot of that product may be recalled.

  7. Medical device - Wikipedia

    en.wikipedia.org/wiki/Medical_device

    This article needs to be updated.The reason given is: the section related to E.U. needs further updates (esp. in sections 3.2 and 4.2.2) as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...

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