Blogs
Medical Devices–Asia Regulatory Updat…
Japan(PMDA)
MHLW Pharmaceuticals and Medical Devices Safety Information (FY2021) No. 387
At t…
Real World Data and Real World Eviden…
Use of Real World Data and Real World Evidence to Support Regulatory Decision Making for Drug and Bio…
Reclassification of Spinal Implantabl…
This guidance is to assist sponsors and manufacturers of spinal implantable medical devices to unders…
Control of Nitrosamine Impurities in …
FDA is implementing Pharmaceutical Quality/ Manufacturing Standards/ Current Good Manufacturing Pract…
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The draft guidance is intended to provide information regarding the recommended documentation to incl…
Don’t miss out! Click here to stay in touch.
Categories
Most used Tags
CONNECT WITH US
