Feb 2, 2023
Asia
The article provides an overview of the new draft guidance and highlights the key points to be considered. Table Of Contents: The National Health Regulatory Authority (NHRA), a Bahrain’s agency responsible for healthcare products regulations, has published a guidance...
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Jul 11, 2022
Asia
The new article describes in detail the general rules related to the importation permits, as well as certain specific aspects, such as violations, product classification, sampling, and fees. The document constitutes a draft guidance the authority has published in...
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May 18, 2022
Asia
The article provides an overview of the regulatory requirements and procedures related to the importation of medical devices. The document constitutes a draft guidance the authority has published in order to collect feedback from industry representatives and other...
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Oct 27, 2021
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission in the sphere of medical devices, has published a guidance document dedicated to the current classification rules. The document is intended to assist medical device manufacturers...
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Aug 30, 2021
Canada
Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to recalls. The document is intended to provide medical device manufacturers and other parties involved with additional clarifications...
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