For the medical devices required for inspection by the competent authority , the obligatory inspection applicants shall submit the following documents to the inspection authority to carry out the inspection:
1. An application form for inspection.
2. A copy of medical devices permit license.
3. A copy of application for import declaration.
4. Necessary documents required by the competent authority.
The application of the preceding paragraph can be submitted electronically.
Medical devices that conform to one of the following situations can be exempted from inspection:
1. Products to be imported are issued with a certificate of examination by the government of the country of origin who has signed an inspection waiver reciprocity agreement with the government of the Republic of China.
2. A special permit from central competent health authority granted for national emergency situation or to improve the public welfare.

In addition to documentation review (as prescribed in Article 9), inspection authority can carry out the medical devices inspection in one or some of the following measures:
1. Batch-by-batch examination: The inspection is carried out for each submitted batch of medical devices.
2. Randomly-selected batch examination: The inspection is performed based on a 2%-50% inspection rate.
3. On-site inspection: verification of items, packaging, appearance and labels of products on site.
The methods for inspection and the items and methodologies for examination of imported medical devices as prescribed in Annex II.

• Annex II.pdf