Mauritius medical device regulations

Selected original pages establish identity, complete PartVI regulations9–10 on COVID-19 antigen self-testing-kit definition, wholesale buyers, sale register and production on demand, plus regulations11–14 and express repeal/savings for GN245/2021. The read PartVI does not carry forward GN109/GN245 universal user-record and positive-result-notification clauses. Later amendments/repeal through2026 remain unverified. This is not a later amendment to GN100/2021 medical-device clinical-trial regulations.

Complete one-page original inserts COVID-19 rapid antibody test as Third Schedule item38 of GN160/2017, made and commenced31December2021. Principal regulation2 defines Third Schedule goods as prohibited and regulation3 prohibits their import. This antibody-test entry must not be merged with the antigen home self-testing-kit restricted-import entries in GN82/2021. Later schedule amendments and current applicability remain unverified.

Historical selected-page expression: title and Gazette identity; complete PartVIII regulations20–22 on COVID-19 antigen self-testing kits; regulation25 revoking GN109/2021 with savings; regulation26 commencement. GN155/2022 regulation13 subsequently expressly revokes this instrument with savings. Pages2–8,11,13–46 are not included in this expression. Non-device passenger/vaccine wording adjacent on the same physical pages is source context, not a general device obligation. Later currentness is not established. Express repeal is proven by the bound successor original; the historical record is marked repealed. This does not establish currentness of successor instruments or country closure.

Historical COVID-19 antigen self-testing-kit sale/use instrument. Complete two-page text includes restricted wholesale buyers, sales and user registers, positive-result notification and commencement. It is expressly revoked by GN245/2021 regulation25(1)(g), with savings in25(2); the authority copy also labels it repealed. These historical obligations must not be presented as the current GN155/2022 requirements. Express repeal is proven by the bound successor original; the historical record is marked repealed. This does not establish currentness of successor instruments or country closure.

Complete two-page original adds COVID-19 Home Self-Testing Kit tariff entries3002.15.10 and3822.00.20 to the Fourth Schedule and eligible importer conditions to the Sixth Schedule of GN160/2017. Principal regulations2–6 explain restricted goods/import permits. The amendment was made and commenced9April2021; the later consolidated tariff/schedule amendment chain is not verified. Native extraction with printer-proof ghost paths is not used as visible legal text.

Complete sixteen-page regulation published in Government Gazette No. 56 of 7 May 2021, including device trial licensing, classifications, fees and schedules. Its subject is medical-device clinical trials. General medical-device market authorisation is a separate regulatory scope.

Selected dependency pages only: title; regulation2 prohibited/restricted goods definitions; regulations3–6 prohibition, restricted-goods permit, application before shipment/entry, Sixth Schedule restrictions, permit validity and changes. Device relevance is established by the direct COVID-19 IVD amendments GN82/2021 and GN327/2021. Physical page2 and pages7–53, including the Fifth Schedule application form, are not included/read for this expression. This2017 source is not a current consolidated import schedule; issue/commencement dates have not been established from the selected pages.