Blogs
FDA Launches New Interactive 510(k) T…
US FDA announced the voluntary electronic Submission Template and Resource (eSTAR) Pilot Program as a…
TGA Issues New Guidance for TGO 101 (…
The new guidance helps sponsors and manufacturers of medicines understand the role of the Therapeutic…
Europe: Medical Device Incident Repor…
Each year, the regulatory authorities receive several hundred thousand medical device reports of susp…
Brazil – General Provisions for…
ANVISA published the Resolution RDC 318/2019, which details about the criteria for carrying out stabi…
China’s CMDE Announces New Regulation…
The Center of Medical Device Evolution (CMDE) of China has released a regulation (notification 53) th…
An Overview of European Unique Device…
The Medical Device Regulations (EU 2017/745, EU 2017/746) introduce the Unique Device Identification …
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