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Chapter Law Content

Chapter 3 Inspection Procedures
Article 8
The inspection authority may proceed product inspection with the following measures:
1. Batch-by-batch inspection: Inspect each submitted batch of product by on-site verification and sampling analysis basis.
2. Randomly-selected batch inspection: Randomly select each submitted batch of product by following inspection rate, and inspect the chosen product by on-site verification and sampling analysis.
(1)Regular randomly-selected batch inspection: The inspection is performed based on a 2-10% inspection rate.
(2)Reinforced randomly-selected batch inspection: The inspection is performed based on a 20-50% inspection rate.
3. Batch-by-batch verification: On-site inspect each submitted batch of product.
4. Certification inspection: Certificate Document inspection for an excellent industry which is registered by an entente or agreement between the health and safety competent authority of Taiwan and the exporting country.
5. Oversee inspection: For specific products, each submitted batch of product shall be inspected by on-site verification and sampling analysis. And the inspection rate is not changed by the inspection result.
For those products not be selected in randomly-selected batch inspection, the inspection authorize may exam extra by on-site verification and sampling analysis; For products be designated for batch-by-batch verification, the inspection authorize may exam extra by sampling analysis.
Article 9
Products applied for inspection that belong to one of the following situations shall be inspected on a batch-by-batch basis:
1. Products proved to cause harm to humans according to domestic and foreign product safety information or scientific evidence.
2. Products designated for batch-by-batch inspection are listed in the TFDA annual inspection plan (hereinafter as “inspection plan”) for imported products.
3. Products with the same origin and commodity classification code of the Republic of China (hereafter referred to as ‘CCC Code’) as preceding batches of products belonging to reinforced randomly-selected batch inspections of the same obligatory inspection applicant, and whose inspection results do not conform to regulations.
4. For products applied to oversee inspection and fail the inspection two batches in a row.
5. The inspection authority determines that it is necessary to carry out the inspection on a batch-by-batch basis.
Prior to the completion of the batch-by-batch inspection procedures for the preceding batch, the batches re-applied for inspection to such batch of products shall be subject to inspection on a batch-by-batch basis.
Article 10
Products applied for inspection that belong to one of the following situations shall be inspected on a reinforced randomly-selected batch basis:
1. Products designated for reinforced randomly-selected batch inspection are listed in the inspection plan for imported products.
2. Products applied for inspection originally belong to batch-by-batch inspection, and the same obligatory inspection applicant has imported five consecutive batches of such products from the same origin and CCC Code, and whose laboratory examination results conform to regulations. However, if the preceding batch before these five consecutive batches of the same obligatory inspection applicant failed to conform to regulations, then the quantity of these five consecutive batches of such products shall be three times greater than the preceding batch of unqualified products.
3. Products with the same origin and CCC Code as preceding batches of products belonging to regular randomly-selected batch inspection of the same obligatory inspection applicant, and whose inspection results do not conform to regulations.
4. The inspection authority determines that it is necessary to carry out the inspection on a reinforced randomly-selected batch basis.
For products applied to inspection originally belongs to batch-by-batch inspection, the inspection authority may not be restricted by the restrictions stipulated in the preceding paragraph based on its considerations of health and safety.
Article 11
Products applied for inspection that belong to one of the following situations shall be inspected on a regular randomly-selected batch basis:
1. Products do not apply to batch-by-batch inspection, reinforced randomly-selected batch inspection, certification inspection or oversee inspection.
2. Products applied to inspection originally belongs to reinforced randomly-selected batch inspection, and the same obligatory inspection applicant has imported five consecutive batches of such products from the same origin and CCC Code, and whose laboratory examination results conform to regulations. However, if the preceding batch before those five consecutive batches of the same obligatory inspection applicant fail to conform to regulations, then the quantity of these five consecutive batches of such products shall be three times greater than the preceding batch of unqualified products.
For products applied to inspection originally belongs to reinforced randomly-selected batch inspection, the inspection authority may not be restricted by the restrictions stipulated in the subparagraph 2 of preceding paragraph based on its considerations of health and safety.
Article 12
If an obligatory inspection applicant imports products after failing on-site verification for products belong to the same origin country and CCC Code, those products shall be inspected on a batch-by-batch verification basis.
If three consecutive batches of products designated for batch-by-batch verification in preceding paragraph conform to regulations, and the total amount reach two times as the previous unqualified products, then the same products for future import can be exempt from batch-by-batch verification.
Article 13
The inspection authority may adopt oversee inspection on specific products based on considerations of health and safety.