The Food and Drugs Authority, Ghana as part of its mandate and in its bid to help combat the spread of the CORONAVIRUS (Covid-19), has stepped up efforts aimed at educating the populace in the acquisition, pricing and use of nose masks.
In this regard, the FDA, Ghana in collaboration with the National Commission for Civic Education (NCCE) has outlined series of activities which will help educate the general public on the processes involved in the production and registration of nose masks and the correct usage and essence of the masks.
Head of Medical Devices Department at the FDA, Mr. Joseph Bennie, at a meeting on Wednesday, April 29, 2020 took representatives of the NCCE, Mr. Rockson Gbande, Deputy Director of Programmes and Mr. Aziz Laryea of the Communication and Corporate Affairs Department, through a comprehensive session of the criteria for production and registration of nose masks.
Mr. Bennie intimated that a nose mask can only be approved when it meets the set criteria of the FDA. These criteria include a three (3) layer mask produced using fabric which is free from any chemical being calico or plain cotton material. He affirmed that the inner and middle layers of the three (3)-layered mask must be solely unprinted material but the outer layer may, in some cases, be made from printed or treated material. Reasons for this, he said, stem from the fact that chemicals can be toxic and some people can be allergic to chemicals used in treating the printed and dyed materials.
Addressing the issue of registration of the nose masks, Mr. Bennie said nose masks are classified as Class 1 medical devices and are thus subject to regulation by the Food and Drugs Authority. He identified the legislative instrument by Parliament that empowers the Authority to charge fees for the registration of products. He further stated that the registration fee, inclusive of laboratory analysis, is Seven Hundred and Fifty Ghana Cedis (GHC750.00), valid for a period of three years, that is, an annual fee of Two Hundred and Fifty Ghana Cedis (GHC250.00) plus an annual facility licensing fee of One Hundred Ghana Cedis (GHC100.00). He professed that the Food and Drugs Authority has absorbed a fee of One Thousand Three Hundred Ghana Cedis (GHC1300) that ordinarily, would have been paid by manufacturers of these masks. Mr. Bennie further explained that the Four Hundred and Fifty Ghana Cedis (GHC450.00) listing fee is for non-commercial entities like hospitals and NGOs which do not intend to sell the face masks.
The Head of the Medical Devices Department in summing-up, stated that all registered and approved nose masks will have an FDA registration number which manufacturers would be expected to place on the product and urged the general public to look out for these numbers that serve to authenticate registered products. He also indicated that the list of all registered and approved face masks will be continually published by the Authority for the general public to take note.
Mr. Rockson Gbande and Mr. Aziz Laryea of the NCCE thanked the FDA for the for the collaboration and assured the Authority of effectively assisting the FDA in the dissemination of pertinent information regarding face masks aimed at educating the public in these precarious times. Ms. Dennisila Baidoo of the Communication and Public Education Department (CPED) of the FDA indicated that education materials developed by the FDA would be shared with the NCCE to help in the public education exercise.
The FDA exists to protect public health by assuring the safety, efficacy and security of human and veterinary drugs, food, biological products, cosmetics, medical devices, household chemical substances, tobacco and the conduct of clinical trials in the country.