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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…
Medical Devices – USA/Europe Regulato…
EUROPE
1. Clarification on “first certification for that type of device” and corresponding procedu…
Authorization of Medical Devices base…
The fast evolution of medical technology and the essential role of medical devices in the health care…
Safety and Performance (SSP) of Class…
The Regulation (EU) 2017/745 on medical devices requires that the manufacturer shall draw up a summar…
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