Angola medical device regulations

Historical Health Ministry decree with all seven articles and both annexes on SARS-CoV-2 antigen-testing service certification. It provides pharmacy authorization conditions, updated pharmacy/test lists, ReDIV reporting, two printed reporting forms and attached positive-result procedures. The Gazette is dated 5 January 2022 and the ministerial text is dated 30 December 2021. This pandemic service source is not a general device market-authorization rule; later measures and current applicability remain unverified.

Complete decree and organic statute establishing ARMED, including its device/health-technology registration, licensing, inspection, vigilance, clinical-trial and quality-control powers and the three organisational annexes. The Gazette scan is preserved by LEX.AO. Unrelated Gazette contents before and after the instrument are excluded. The separate government education-ministry PDF omits intermediate pages of this decree and was therefore not used as the corpus source.

Complete two-page historical customs-clearance order dated 10 March 2022. Point 2 specifies Portuguese invoices and certificates of origin for equipment, adding an ARMED import certificate for rapid infectious-disease diagnostic tests; point 3 provides common application particulars. Medicine-specific requirements and personal-use provisions remain distinct. The source is an archived official PDF, with later instructions and current applicability unverified.

Historical ARMED order on infectious-disease rapid diagnostic tests, with the complete four-point order and Annex I. It addresses validated-test lists, prior import authorization, importer/manufacturer monitoring and technovigilance, and the INIS validation and release process. The annex refers to 300 samples per lot and a possible 20–40 day INIS response while stock remains detained; this is not a general device registration deadline. Retained from an archived official PDF dated 22 February 2022; later applicability and referenced test lists remain unverified.

Complete historical one-page ARMED order dated 10 March 2022, addressing INIS-validated SARS-CoV-2 rapid tests and stating that importation and commercialization of SARS-CoV-2 self-tests are not authorized. Its pandemic-specific scope and printed 136/20 citation are retained. This archived official expression does not establish a restriction on all IVDs or prove current applicability.