Provisions governing medical device items requiring border inspection by the central competent authority are listed in Attachment 1.

• Attachment 1.pdf

In accordance with the provisions of Paragraph 1 of Article 52 of the Act, obligatory inspection applicants who apply to import medical devices referred in the preceding article shall file the completed application form for inspection and submit the following documents and information to the inspection authority at the port where the medical devices are to be imported, 15 days prior to the date of inspection:
1. A photocopy of the medical device license or listing, or approval document to import the medical devices as a special case.
2. A photocopy of application for import declaration.
3. Other documents and information designated by the central competent authority.
If the application is to be filed by a representative, an identification document for the representative and a letter of power of attorney shall be provided unless the obligatory inspection applicant can provide a copy of the long-term entrustment agreement and has notified the inspection authority of the entrustment.
The central competent authority may require the obligatory inspection applicant to submit the application of the preceding paragraph electronically.
In the event that the inspection authority discovers that the application documents and information are not complete but corrections can be made, the inspection authority shall notify the obligatory inspection applicant who shall make corrections within 20 days. In the event that the applicant fails to make corrections before the designated deadline, the application shall be rejected.

Imported medical devices conforming to one of the following situations can be exempted from inspection referred to the preceding article:
1. Imported medical devices are for exclusive use as samples or for personal use only in accordance with the provisions of Subparagraph 4, Paragraph 1 of Article 35 of the Act.
2. Imported medical devices are originally manufactured domestically and exported ,and they are shipped back to Taiwan with the approval of the central competent authority.
3. Imported medical devices are issued with a certificate of examination by the government of the country of origin who has signed an examination waiver reciprocity agreement with the government of the Republic of China.
4. The import has been approved by the central competent authority for national emergency situation or to improve the public welfare.