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