H-Metro Reporter
THE Medicines Control Authority of Zimbabwe (MCAZ) intends to introduce regulations governing the registration and use of in vitro diagnostics (IVDs) in the country.
This includes HIV test kits, pregnancy test kits, COVID test kits.
This follows concerns that there is a proliferation of substandard and counterfeit IVDs in the country.
MCAZ has come up with regulations to control in vitro diagnostics.
Speaking to journalists, on the sidelines of a consultative meeting with stakeholders on IVD regulations MCAZ, Head of Licensing and Enforcement, Caroline Dandira-Samatanga, said faulty medical devices have been and could be in use but the Authority enforcement is hamstrung due to absence of IVD regulations.
“Medicines Control Authority of Zimbabwe has come up with regulations to control in vitro diagnostics, this includes things like your test kits, HIV test kits, pregnancy test kits, COVID test kits,” she said.
“We want to make sure that these are of good quality, they are safe and they are effective.
“When you are tested or you are diagnosed, we know that the device is giving you the good result that you require so that you can have good treatment and there’s no time wasted.
“So, we’ve been coming up with regulations and a number of issues have been recorded where poor quality diagnostics have also been in use.”
She added:
“Should we come across another pandemic, this is the procedure we are going to take.
“We already have some on the market, but we are not sure. Nobody is regulating them as yet, but we want to make sure that they are of good quality, they are safe and also effective.”
She said a grace period to register IVDs already on the market will be afforded to various players.
“We will come up with transitional arrangement and communicate as much as possible with stakeholders on what they are going to do, how they are going to handle those that are already on the market.
“We will register them and give people time to regularise.”