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)

Decreto Exento N° 41 del Ministerio de Salud, de fecha 08 de junio de 2022: Incorpora al régimen de control sanitario establecido en el artículo 111 del Código Sanitario, a los dispositivos para detección de VIH que indica (Ministry of Health Exempt Decree No. 41 of 8 June 2022 adding the indicated devices for HIV detection to the health control system established in Article 111 of the Health Code) (3 pages, in Spanish)

Draft Commission Regulation (EU) …/…of XXX amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards N,Ndimethylacetamide (DMAC) and 1-ethylpyrrolidin-2-one (NEP); (5 page(s), in English), (3 page(s), in English)