Labeling rules for imported medical devices discussed

meeting
A conference for labeling rules and regulations for imported medical devices and apparatuses being held at UMFCCI in Yangon yesterday.  Photo: May Thet Hnin

Food and Drug Administration Department under the Department of Consumer Affairs held a conference regarding labeling rules and regulations for imported medical devices and apparatuses in cooperation with Myanmar Pharmaceuticals & Medical Equipment Entrepreneurs’ Association on 2 November at UMFCCI, Yangon.
The Consumer Affairs Department announced on 26 October that the products which are being distributed in the local market will be required to use the Myanmar language on their labels along or with other languages. The new regulations cover instructions for use, storage, advice on poisonous ingredients and precautions against possible side effects.
Items covered include food, household appliances, children’s facilities, communications equipment, medicines and food supplements, chemicals, cosmetics, consumer products, and professional equipment.
“Businesses will have six months to comply with the official notification, once it is released. But now, we conducted this conference for the medical equipment importers because they are worried about their procedures,” said U Zaw Moe Khine, chairman of the Myanmar Pharmaceutical & Medical Equipment Entrepreneurs’ Association.
For medical and other supplements, those products which are bought by the doctor’s prescriptions do not need to use Myanmar language. But other varieties of medicines and traditional medicines need label stickers. But some of the products are in too small and they have difficulty sticking the label. For those products, they need to be sold together with pamphlets and leaflets. When they are conducting this process, they need to get recommendations from FDA to see whether those labels and products are matched or not, said an official.
The label stickers are needed to be put on the products which will be distributed six months later. At the end, the products must carry Myanmar label stickers for the consumers. We will not check at the stores, but at the markets. We have already formed Post Market Surveillance for checking the products in the market six mothers later, said U Ye Htut Naing, director of the Consumer Affairs Department.
In doing so, although most of the drug companies can comply with the new rules and regulation, there are still some that find it difficult to comply. Therefore, they had requested to give them six more months for preparations. They are also making complaints that they cannot afford the verification fees and they requested the authorities not to charge the verification fees, said U Zaw Moe Khine.
The instructions were issued according to the 2014 Consumer Protection Law.
The businesses, that fail to follow the instructions, will be given first-time warning, serious warning, fine and fainally, distribution of the products will be banned for a certain period.
The SOP which includes detailed information of the Myanmar label sticker for the goods will be issued very soon by the related Ministry with the assistance of the USAID, according to the Consumer Affairs Department under the Ministry of Commerce.
This instruction will be issued for the businesses to follow before enactment of the Labeling Law. Recently, the new consumer Protection Law is being drawn and will be enacted next year. The new law will include new rules that will require Myanmar labels on the products.

By May Thet Hnin

(Translated by Hay Mar Tin Win)

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