South America
Argentina informs about more upcoming changes in their medical device registration procedures. The appropriate amendments would be implemented in two consecutive steps: on March 6, 2020, and on March 16, 2020, respectively. In particular, the amendments are set forth...
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The Therapeutic Goods Administration (TGA), the Australian authority responsible for medical device regulations, issued detailed and exhaustive research dedicated to the timeframes of procedures related to the medical device registration process describing the typical...
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The Medical Device Authority (MDA), the department of the Ministry of Health in Malaysia, published draft guidance dedicated to notification of refurbished medical devices. The document is intended to assist industry representatives and provide them with the...
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The Food and Drug Administration (FDA), the US agency responsible for medical device regulation, has published a list of Class I and Class II medical devices exempt from the obligatory premarket notification requirement. Scope of Exemption According to the general...
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The Malaysian Medical Device Authority (MDA) issued official guidance dedicated to notification for orphaned medical devices. Scope of the Guidance The document was published by the MDA in order to assist all parties involved in operations with medical devices to...
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