The New Taipei City Department of Health yesterday confirmed that Team Power Healthcare had imported unapproved masks from China and relabeled them as made in Malaysia.
Food and Drug Management section head Yang Shu-chin (楊舒秦) said that Team Power Healthcare did have a medical device permit license for masks manufactured in Malaysia, but had moved its manufacturing site to China and did not apply for a new license immediately.
“The company imported the masks [from China] before obtaining a [new] medical device permit license, so it contravened Article 83 of the Pharmaceutical Affairs Act (藥事法),” she said.
Photo courtesy of New Taipei City Department of Health
The company’s actions appear to have also contravened Article 255 of the Criminal Code, and the New Taipei City Prosecutors’ Office would open its own investigation.
Article 83 stipulates that “any person who manufactures or imports medical devices without obtaining prior approval may face imprisonment up to three years or a fine up to NT$10 million [US$340,368],” Yang said.
Article 255 stipulates that a person found guilty of intent to defraud others by making a false mark or indication of the country of origin or quality on merchandises could face up to one year in prison or a fine up to NT$30,000.
Earlier this month the department received a list from the central government of companies with unusual imports, including Team Power Healthcare, and the central government and the city cooperated in investigating the companies, Yang said.
Further details on the case, including the manufacturing site of the masks, the number of masks imported and where they were sold, are still under investigation by the Investigation Bureau’s New Taipei City Field Division, and cannot be released, she said.
The Chinese-language Want Weekly (周刊王) yesterday reported that the New Taipei City Department of Health issued a document on Tuesday last week informing the New Taipei City Medical Instruments Commercial Association of alleged illegal behavior by Team Power Healthcare on Sept. 4, so healthcare facilities in the city should pull the firm’s masks from their shelves.
Want Weekly cited a medical device salesperson identified only as Amy as saying that the company had for more than a decade been selling medical products, including masks and sterile gauze made in China, as made in Malaysia.
New Taipei City Mayor Hou You-yi (侯友宜) told reporters that the investigation was a good example of collaboration by the central government, the city’s health department and the bureau’s New Taipei City Field Division, adding that those responsible for the illegal imports would be held accountable.
In Taipei, Minister of Health and Welfare Chen Shih-chung (陳時中), head of the Central Epidemic Command Center, said the government would look into some bids the company was involved with, in addition to tracing where it sold its masks.
Additional reporting by CNA
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