Singapore HSA revises guidance and technical documents

Singapore – Singapore’s HSA finalizes LDT guidelines

Singapore’s Health Sciences Authority (HSA) has finalized guidance intended to help clinical laboratories understand the regulatory requirements for tests they develop internally. To date, HSA...
ANVISA will implement new rules for medical device modifications in Brazil

Brazil – ANVISA approves skinny labeling in Brazil

On December 6, the Board of Directors (DICOL) of the Brazilian Food & Drug Agency (ANVISA) passed new regulations accepting an exemption to allow...

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