Control of safety and quality of face masks

Since the corona outbreak nearly two years ago, there have been many local entrepreneurs who are making face masks and selling them. Are there laws or regulations made by the relevant Ministry to regulate the safety and quality of masks that are produced locally? Is local production of masks really regulated to ensure our safety? 
TN, Mwanza

Masks are a medical device in terms of the Tanzania Medicine and Medical Devices Act [Cap.219 R.E 2021] and the Pharmacy Act, 2011 because they are used for prevention of diseases. Therefore, safety and quality of masks locally produced are under statutory control though there might be some relaxation in enforcement of the law.

Regulation 6 of the Tanzania Medicine and Medical Devices (Control of Medical Devices) Regulations requires all local manufactures of masks to be registered with the Tanzania Medicine and Medical Devices Authority. Additionally, masks produced by the local producer should also be registered with TMDA and the premises where the masks are produced or stored for distribution should be registered with TMDA. TMDA can only issue a licence to produce masks where it is satisfied with the quality and safety of the masks being produced. In exercising its power, TMDA has power to prescribe the quality of the masks to be produced and it is an offence under section 59(2) of the Act to produce masks that are below the qualities prescribed by the TMDA.

In 2020 the TMDA issues the Guidelines prescribing the qualities to be met by local manufacturers of masks. The Guidelines prescribe about eight qualities of the masks other than surgical masks. The Minister for Health has power under the law to prohibit production of masks if he/she is of the view that certain masks endanger life of the people. Hence, there is a legal framework for enforcement of the quality and safety of the locally produced masks.