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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The draft guidance is intended to provide information regarding the recommended documentation to incl…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…
ICH Guideline E8 (R1) on General Cons…
Clinical studies of medicinal products are conducted to provide information that can ultimately impro…
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