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Laws & Regulations Database of The Republic of China (Taiwan)

Print Time:2024/11/22 11:31
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Chapter Law Content

Chapter 2 Product Surveillance
Article 5
The type certification body shall have an annual implementation plan based on the risk level of the products it certifies.
The implementation plan mentioned in the preceding paragraph shall cover the factory's production processes of type-certified products, checks of production and distribution records and sampling inspection.
The risk level of products mentioned in the first paragraph may be determined by factors such as the violation records of the manufacturer or type-certified products, occurrences of incidents, noncompliance records of purchased or sampled products, quality assurance of factories, or place of origin.
Article 6
To monitor type-certified products, the type certification body shall assign professionals to perform the following tasks at the production premises or warehouses of the products, whereas surveillance of production processes shall only be carried out at the production premises:
1.Surveillance on products: including sampling inspection and checking of the production and distribution records.
2.Surveillance on production processes: including the management of raw materials and components, inspection and testing of semi-finished and final products, verification of consistency in safety specifications of products at the production premises with type-certified products.
The type certification body shall make product surveillance records of the surveillance mentioned in the preceding paragraph and maintain them properly.
Article 7
The type certification body shall sample products from the most recent batch of type-certified products, including the main type and series of type, and compare on site with the information listed in the type test reports and technical files.
Where the type certification body considers it necessary, it may perform testing on site or take back the sampled products for further testing based on the findings of the on-site comparison, and make records.
Article 8
Under any of the following circumstances, the type certification body shall sample products on site and take them back for testing when it performs surveillance on production processes, except where it is not easy to take back the products:
1.Where there are no testing facilities at the surveillance place;
2.Where there are discrepancies as a result of the on-site comparison or testing; or
3.Where there are doubts requiring further clarifications.
Article 9
Where the type certification body determines noncompliance of the production and distribution records during the surveillance on type-certified products, it shall notify the person subject to inspection to take corrective actions within a certain time limit and put it on the list of prioritized surveillance.
Article 10
Where the type certification body confirms that the purchased or sampled type-certified products do not comply with the safety standards, it shall report to the central competent authority for rescinding the certificate of type-certification of the products and notify relevant parties to recall the products within a certain time limit.
The type certification body shall conduct market checks to follow up the status of recall after the time limit expires.
Article 11
For products registered at the Safety Information Reporting Website or granted certificates of type certification, manufacturers or importers shall have production and distribution documents concerning such products, such as dates of manufacture, types, specifications, quantities, dates of shipment, clients, complaints records and service records, and maintain related technical files for non-periodic checks by the central competent authority or labor inspection bodies.
Web site:Laws & Regulations Database of The Republic of China (Taiwan)