2013 Compliance Informed Consent Licensing 
SQA
MAY 17, 2022
ANVISA’s RDC 665/2022 (link in Portuguese) replaces previous regulations, including RDC 16/2013 and IN 08/2013, and went into effect on 02 May 2022. China Regulatory Roundup: Latest Guidelines for Medical Device and IVD Compliance, 17 March 2022.
Drug & Device Law
DECEMBER 29, 2023
Plaintiff knew about it, too, since he signed an informed consent document mentioning it. Negligence requires an evaluation of a defendant’s reasonableness, and all relevant NC authority includes relevant regulatory compliance in that mix. Plaintiffs’ own litigation strategy thus opened the door to compliance evidence.
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