(Taiwan) Medical device registration to be simplified: DOH :: BiotechEast - Taiwan and China biotechnology, medical devices, pharmaceuticals, ^¤å½s×, ^¤å×§ï ::

(BiotechEast Staff)

28 April, 2006
The Department of Health (DOH) on Thursday announced it was making life significantly easier for companies wanting to register and sell medical devices in Taiwan.

The announcement was made at the first of a series of forums taking place in Taipei aimed at both the local and the international medical device communities.

The focus of this forum was to explain the current Premarket Approval Application (PMA) procedures for medical device registration in Taiwan, how this procedure in Taiwan compared with other countries, and recent efforts to reform these regulations.

Registration in Taiwan for medical device companies had become notoriously difficult since the passing of a law in 2005 requiring companies to go through PMA for even Class I devices. As such, companies wishing to register even the simplest of products had to submit reams of data to the DOH, including clinical data, with registration taking an average of 140 days to complete.

Although the law was intended as a public health safeguard, no other country in the world had enacted such stringent regulation requirements. For low-risk Class I and II devices, most countries required some form of pre-market notification only, with only Class III devices requiring the submission of a PMA.

With the announced simplification, companies now wishing to register Class I devices simply have to fill in a simple form at the Bureau of Pharmaceutical Affairs of the DOH (the office responsible for approving medical devices), cutting the completion time down from 140 days to an estimated 15 minutes.

The DOH will also try to simplify current PMA procedures for Class II and III devices, according to presenters at the forum.

Putting on the forum on behalf of the DOH was the Medical and Pharmaceutical Industry Technology and Development Center (but still known by their old acronym PITDC). The PITDC is a non-profit organization formed to help raise the technological standards of local biomedical industries, and to act as a bridge between industry, government, and the academic community.

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