Wed, Jul 23, 2014 - Page 3 News List

FDA eases rules on stair-climbing wheelchairs: Yang

MOBILITY:The lawmaker appealed to government agencies to increase the subsidy for stair-climbing wheelchairs to help more people who are in need

By Stacy Hsu  /  Staff reporter

An estimated 400,000 disabled people in the country are confined to their homes because of a lack of elevator facilities, but that is set to change after the easing of restrictions on imports of stair-climbing wheelchairs, a lawmaker said yesterday.

“After a long time of waiting, people with mobility impairments who have been stuck at home for years will finally be able to leave their houses and enjoy the world outside because the first certified stair-climbing wheelchair will be out in the market in no time,” Chinese Nationalist Party (KMT) Legislator Yang Yu-hsin (楊玉欣) told a press conference.

The Food and Drug Administration has reclassified stair-climbing wheelchairs from medium-risk class II to class I, Yang said.

The reclassification means that Taiwanese importers of stair-accessible wheelchairs will no longer have to spend a lot of time and money entrusting a certified body to inspect foreign manufacturers’ factories to ensure they comply with Taiwan’s good manufacturing practice (GMP) standards.

The requirement is the primary reason no imported stair-accessible wheelchairs have yet to be allowed on the shelves in the country.

Following the reclassification, which is expected to take effect next month, importers will only need to sign an affidavit guaranteeing that the manufacturers meet GMP standards, in addition to submitting documents proving that the devices conform to the IEC60601-1 international standards for medical electrical systems and the requirements for stair-climbing wheelchairs stipulated in the ISO 7176-28.

However, as the government only plans to offer a maximum subsidy of NT$80,000 for each stair-accessible wheelchair — which could cost up to NT$300,000 — for people from low-income households, Yang urged relevant agencies to consider increasing the subsidy to make the device more affordable to those in need.

“The government is also advised to set up a wheelchair rental system, or join forces with civic groups and non-governmental welfare organizations to allow economically disadvantaged people to enjoy the equipment at a reasonable rate,” Yang said.

Also present at the press conference were Taiwan Association for Disability Rights executive director Peter Chang (張宗傑), Chinese Safe Patient Handling and Movement Association director-general Walter Kuo (郭外天) and Taiwan Motor Neuron Disease Association director-general Liu Yen-chu (劉延鉅).

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