Sat, Oct 27, 2018 - Page 3 News List

Medical equipment sales on social media targeted

By Peng Wan-hsin and Jake Chung  /  Staff reporter, with staff writer

Social media, such as Facebook and Line, are to be prohibited from selling medical equipment, with those breaching the regulations to be fined between NT$200,000 and NT$5 million (US$6,450 and US$161,259) if the draft medical devices management act is passed by the legislature.

The Social Welfare and Environmental Hygiene Committee on Thursday approved an initial review of a draft act.

Article 42 of the draft proposes that media, including social media platforms, should not air advertisements for medical equipment that has yet to be approved by the central government or the competent authority of the local government.

Article 25 proposes that the import or manufacture of medical equipment should be registered with the competent authority and that imports should not be initiated until a permit is issued.

Those who contravene Article 25 would face a prison sentence of up to three years and a fine of up to NT$10 million.

Restrictions for low-risk medical equipment, such as crutches, would be lower and the import or manufacture of such items could be registered online.

The process for applying for low-risk medical equipment for clinical purposes would be simplified and would only require a hospital’s agreement, and would no longer have to be approved by the Food and Drug Administration, according to the draft act.

The government should verify the registered information and would have the power to inspect the products being sold commercially.

Each piece of medical equipment would have a three-year approval period and approval would have to be renewed every three years.

Food and Drug Administration senior specialist Tu Pei-weng (杜培文) said that those selling non-approved medical equipment claiming to heal certain injuries could be fined under Article 66 of the draft act.

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