Extension of the Regulatory Flexibility for Class B, C and D Medical Devices that are Not Included in the List of Registrable Medical Devices Based on FDA Circular No. 2020-001-A entitled "Amendment to Annex A of FDA Circular No. 2020-001 re: Initial Implementation of Administrative Order No. 2018-0002 "Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements""; (3 page(s), in English)
Proposed establishment of the "Regulations on the Approval, Certification, Notification, Review, and Evaluation of Digital Medical Products"; (94 page(s), in Korean)
Proposal for a Regulation of the European Parliament and of the Council on packaging and packaging waste, amending Regulation (EU) 2019/1020 and Directive (EU) 2019/904 and repealing Directive 94/62/EC (COM(2022) 677 final) (118 page, in English), (Annex - 36 page, in English)
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