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TGA Issues New Guidanc…
The new guidance helps sponsors and manufacturers of medicines understand the role of the Therap…
Europe: Medical Device…
Each year, the regulatory authorities receive several hundred thousand medical device reports of…
Brazil – General…
ANVISA published the Resolution RDC 318/2019, which details about the criteria for carrying out …
China’s CMDE Announces…
The Center of Medical Device Evolution (CMDE) of China has released a regulation (notification 5…
USA: FDA Drafts Guidan…
The US Food and Drug Administration (FDA) released draft guidance on bridging information on pro…
An Overview of Europea…
The Medical Device Regulations (EU 2017/745, EU 2017/746) introduce the Unique Device Identifica…
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