Starting on Sept. 1, prescription goggles can only be sold by shops that have a medical device distributor license, the Taipei Department of Health said.
Lee Hui-chih (李慧芝), a specialist at the department’s Food and Drug Control division, yesterday said that prescription goggles, such as those used for swimming, diving, snow sports, playing squash or other activities, are currently classified as general merchandise, but they are soon to be listed as a first-grade medical device.
That follows an amendment to the Regulations Governing the Management of Medical Devices (醫療器材管理辦法) announced by the Ministry of Health and Welfare in June last year, and is to be enforced on Sept 1.
Lee said that according to the Pharmaceutical Affairs Act (藥事法), only companies that have a license to import, manufacture or sell medical devices can sell prescription goggles.
Several sporting goods stores have applied to the ministry for a license, Lee added.
Manufacturing firms or shops that continue to produce or sell prescription goggles without a license can be fined between NT$30,000 and NT$2 million (US$927 and US$61,803), Lee said.
The department added that medical device distributors must obtain approval from the ministry before selling first-grade and partial second-grade medical devices on the Internet, by mail order or TV shopping networks.
It advised consumers to check and see whether these distributors have a license before purchasing to avoid buying unsafe products from illegal sources.
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