Blogs
Medical Devices – USA/Europe Re…
EUROPE
1. Clarification on “first certification for that type of device” and corresponding procedu…
Medical Devices-Asia Regulatory Updat…
China (NMDA)
1. 2th China International Medical Device Regulatory Forum held in Wuhan Spon…
China – Notice on registration …
On March 5, 2021, the State Food and Drug Administration of China issued an announcement on the Regis…
Color Additive Petitions
FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Dr…
Infusion Pumps Safety Assurance
The US Food and Drug Administration (FDA)’s guidance, entitled “Infusion Pumps Total Product Life Cyc…
Medical Devices – Asia Regulatory Upd…
Philippines (FDA)
1. Addendum to FDA Circular No. 2021-002 Re: Full Implementation of Administrati…
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