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)

Draft amendments to the Rules for marketing authorization and assessment of medicinal products for human use; (24 page(s), in Russian)

Draft Order of the Ministry of Health of Ukraine "On Approval of Amendments to the Procedure for Confirmation of Compliance of Manufacturing Conditions of Medicines with the Requirements of Good Manufacturing Practice"; (10 page(s), in Ukrainian)