Blogs
Categorization and Registration Proce…
Categorization of Devices
Categorization of devices to be registered in EUDAMED include:
Regul…
Guidance on Premarket Submission for …
The draft guidance is intended to provide information regarding the recommended documentation to incl…
Medical Devices – USA/Europe Regulato…
EUROPE 1. MDCG 2021-26 – Q&A on repackaging & relabelling activities under Article 16 of Reg…
WHO Recommendations for screening and…
Too many women worldwide – particularly the poorest women – continue to die from cervical cancer; a d…
Medical Devices – Asia Regulatory Upd…
Philippines(FDA)
1.FDA Circular No.2021-0021: Guidelines on the Licensing of Retailers of Medical…
Guiding Principles for Good Machine L…
The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and He…
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