Blogs
TGA: Regulatory Impact Statement R…
Technology changes have the potential to deliver significant advantages and opportunities to Australi…
Danish Medicines Agency Recommended N…
Danish Medicines Agency recommended a new regulation on medical devices (MDR 2017/745) is effective f…
TMDA Released Guidance on the Import …
Turkish Medicines and Medical Devices Agency (TMMDA) issued guidance in order to determine the princi…
FDA Issues Guidances on Dual 510(k) a…
The US Food and Drug Administration (FDA) finalized two guidance’s providing recommendation for Dual …
FAMHP: New Legislative Measures for U…
This new regulation offers for extra measures to limit the unavailability of medicines. On 3 February…
FDA Launches New Interactive 510(k) T…
US FDA announced the voluntary electronic Submission Template and Resource (eSTAR) Pilot Program as a…
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