Taiwan Medical Device Regulations

All documents listed below were published by the Taiwanese Department of Health and are in PDF format. Please help us maintain this list by reporting outdated or missing documents to marketing [at] emergogroup [dot] com. If you need help determining the regulatory requirements for your medical device in Taiwan, you may be interested in our custom regulatory strategy reports for Taiwan.

Major Regulations

• Regulations Governing Management of Medical Devices

General Guidance Documents

• Guidelines for Registration of Medical Devices

Specific Guidance Documents

• How to apply for Medical Device License in Taiwan