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FDA Guidance on Application Requirements for Devices
The Food and Drug Administration (FDA), the US agency responsible for medical device regulation, issues guidance dedicated to requirements for certain Class II applications. Medical Devices for Percutaneous Coronary...
Vietnam Amends Medical Device Regulations – 2019
The Government of Vietnam, at the proposal of the Minister of Healthcare, has published a decree amending and supplementing national medical device regulations. The proposed amendments aim to modify a wide scope of...
Argentina Updates Medical Device Registration Rules
The National Administration of Drugs, Foods and Medical Devices (ANMAT), Argentina’s regulating authority in the sphere of medical device circulation, has recently issued the updated rules regarding the registration of...
FDA Publishes Order Regarding 510(k) Exemption
The Food and Drug Administration (FDA), the authority responsible for the regulation of medical device circulation in the US, has issued an order excluding certain Class I and Class II medical devices from obligatory...
Malaysia Issues New Medical Device Regulations
The Medical Device Authority (MDA), a special division of the Ministry of Health Malaysia responsible for medical device regulation, has announced new rules introducing additional obligations for medical device...
TGA Guidance on IVD Companion Diagnostics
The Therapeutic Goods Administration (TGA), the division of the Australian Department of Health responsible for medical device regulation, issues guidance on IVD companion diagnostic devices. Definition of IVD...