MCAZ SISI 183 of 2005
SI 183 of 2005 is the official MCAZ identifier for “Medicines and Allied Substances Control (Condom) Regulations, 2005”. SI 183 of 2005 is the official identifier MCAZ uses for this instrument.
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Medicines and Allied Substances Control (Condom) Regulations, 2005
Statutory Instrument 183 of 2005, made by the Minister of Health and Child Welfare under section 74 and after consultation with the Authority under section 38 of the Act. This is the instrument that makes condoms a regulated medical device in Zimbabwe: regulation 2 defines a condom as "a medical device which is intended to be worn on the penis during sexual activity for purposes of contraception and to prevent the spread of sexually transmitted infections", regulation 3 prohibits the sale of unapproved condoms, regulation 4 requires approval to rest on the standards in the Second Schedule, and the remaining regulations set the application route, the notification of approvals in the Gazette, packaging, storage, batch-approval for distribution, labelling and enforcement. Sixteen regulations and two Schedules, the First Schedule being the prescribed form and the Second Schedule the standards and test schedules, whose sampling plans are keyed to ISO 2859-1 (the instrument does not cite ISO 4074).
SI 183 of 2005 is the official identifier MCAZ uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.