Import of surgical masks, medical-use respirators needs FDA approval

Import of surgical masks and medical-use respirators are needed to seek FDA approval, said Dr Khin Chit, Deputy Director-General of Food and Drug Administration Department (FDA), the Ministry of Health and Sports.
“Earlier, COVID-19 prevention items, including surgical masks and medical-use respirators (N95/KN-95), were listed in those that did not require applying for an import licence from the FDA. Now, the surgical masks/ medical-use respirators (N95/KN-95) are required to seek import permit from FDA to enable the people to access the quality protective equipment and to meet more reliable quality standard for health workers,” said the statement issued by FDA on 24 December.
“FDA has already made registration for those items. The N95 and KN-95 masks are registered in FDA and are allowed to import. But, we could not control effectively to get them in time during the pandemic period. We have also released import of the masks because we have to import a big volume of the masks to ensure sufficiency. By doing so, every person can get the masks at an affordable price, and the masks will be sufficient for our country,” said Dr Khin Chit.
However, the import of masks without a licence has been almost a year. If we continue to do so, there could be counterfeit and lower quality products, the FDA deputy director-general added.
“If we continue to allow the import of the masks without a licence, there will be a fake mask problem. We are finding some fake masks and lower quality products in the market. That can cause bigger problems. Now, we are aware of the importance of wearing masks, and everyone is wearing masks whenever they go outside. Only the quality masks can prevent the disease. So, we attempt to get the quality masks for the people,” Dr Khin Chit explained.
On the other hand, we can make a registration for legal import companies. If the companies are still importing the lower quality masks, we can follow their history and take legal action against them.  (Translated by Hay Mar)

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