New regulations to improve quality of medical devices Achieving Maturity Level 3 signifies that MCAZ has developed a stable, well-functioning, and integrated regulatory system ensuring the quality, safety, and efficacy of medicines and vaccines registered by the Authority.

Rumbidzai Mushonga and  Gloria Muruva

Herald correspondents 

Medicines Control Authority of Zimbabwe (MCAZ) is seeking to expand its regulatory scope to cover a wider range of medical devices, including syringes, needles, glucometers, and even complex devices like pacemakers.

In a bid to support locally manufactured medical devices, (MCAZ) is spearheading the regulation of local medical devices.

MCAZ acting director general Mr Farai Masekela explained that currently the agency only regulates condoms and gloves, leaving many other medical devices uncontrolled.

“So what we notice currently, we are not regulating medical devices in general. 

“We only regulate condoms and gloves. But we seek to extend that scope,” said Mr Masekela. 

The proposed new regulations would give MCAZ the authority to assess the quality and safety of locally manufactured medical devices before they can be sold in Zimbabwe.

“This will give confidence to the people in Zimbabwe that whatever devices they are using are of good quality, are safe, and are able to perform the intended task,” said Mr Masekela

The move comes in response to reports of defective products on the Zimbabwean market, such as leaking syringes and urine bags. 

“There’s nothing that you can really do about it without the regulations being present to actually allow you to conduct those investigations or stop those products from being marketed in the country,” Mr Masekela said.

The new regulations will have to go through Zimbabwe’s full legislative process before being enacted. 

“The first part is, once we are done with this stakeholder consultation, this is then taken back to the Ministry (of Health and Child Care), where the Permanent Secretary and the Ministers are going to look at it then take it to Cabinet, then Parliament. 

“We still have a long way to go before this sees the light of day,” he said. 

Mr Masekela added that if implemented, the expanded medical device regulations could also open up export opportunities for Zimbabwean manufacturers whose products meet MCAZ’s quality standards.

“They are also very effective and are able to perform the intended task.

“In addition, we think once we have confidence with these devices, the manufacturers themselves can actually then export the same devices for use in other countries,” he said 

Mr Masekela noted that as a recognised regulator, MCAZ’s certification could allow Zimbabwean-made devices to be accepted for use in other countries. 

“We think if we are able to ascertain the safety and quality of these devices and confirm that they are suitable, then other countries as well may be able to use them as we look at exporting more of these medical devices, in addition, of course, to help our patients benefit from them,” he said.

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