Laws Information

法規資訊
Title: Regulations Governing Monitoring Inspection of Products from Premises with Registered Management Systems
Am Date: 2010-05-14
Legislative History: Amended and promulgated by Ministerial Order on 14 May 2010.

Transaction

Amendment

Article 12-1
Where the registration of production premises registered under these Regulations is revoked or rescinded in accordance with the preceding 2 paragraghs, the production premises shall not re-apply for management-system-based monitoring inspection within 4 months starting from thae date of revocation or rescission.
Article 2
The production premise of a commodity subject to monitoring inspection, while its quality management systems have been registered with the Bureau of Standards, Metrology and Inspection (the BSMI) of the Ministry of Economic Affairs or with certification bodies recognized by the BSMI, may apply for becoming a premise governed by these Regulations (management-system-based monitoring inspection) within the registered scope if it has obtained a monitoring inspection registration certificate and has equipped with basic inspection facilities.
The basic inspection facilities mentioned in the preceding paragraph shall be prescribed by the BSMI. When revised, the BSMI may inform the production premises registered under these Regulations to be equipped with the revised facilities within a given time limit.

Article 3
An applicant shall apply to the BSMI or its branches with jurisdiction over the applicant (the inspection authority) for management-system-based monitoring inspection by submitting the application form, the quality management system certificates and a list of basic inspection facilities. Whenever necessary, the inspection authority may send its representative to conduct an on-site examination, or request samples to be provided by the applicant for performing necessary testing or witness testing on specific features of the commodity. Registration is granted under these Regulations if compliance is found after the review.
If the applicant is a foreign-based premise, the application shall be made by an agent who has its domicile or business place in the Republic of China.

Article 6
The inspection authority may send its personnel to the production premises, storage places at harbors, importers, distributors or any other related places to conduct sampling inspection or witness inspection forproducts that are subject to monitoring inspection under these Regulations. The manufacturers or related personnel of the places shall not refuse such activities.

Article 10
Under any of the following circumstances, the production premises registered under these Regulations shall not be allowed to conduct monitoring inspection mentioned in paragraph 1 of Article 4 for a period of one to six months and their products shall be subject to batch-by-batch inspection.
1. Where the production premises did not countersign monitoring inspection certificates in accordance with provisions of these Regulations;
2. Where a trade dispute arises due to inferior quality of the products that the production premises manufactured and verified by the inspection authority or inspected by organizations of the importing countries;
3. Where the inspection standards have changed and the products of the production premises did not comply with the new standards after a designated date prescribed by the BSMI;
4. Where fraudulent actions are found to have mixed their products with products not under the management-system-based monitoring inspection, products of other brands or non-compliance products;
5. Where violation is found against Articles 5, 7 or 9 of these Regulations;
6. Where markings are not affixed in accordance with Articles 11 or 12 of these Regulations; or
7. Where the sample(s), taken or purchased, are inspected to be not in conformity with related inspection standards.
If non-compliance products are found during the suspended period mentioned in the previous paragraph, the production premises shall not be allowed to conduct monitoring inspection mentioned in paragraph 1 of Article 4 for an additional one-month period.

Article 12
Under any of the following circumstances, the registration of production premises registered under these Regulations shall be rescinded:
1. Where the production premises apply for cancellation of their registration under these Regulations on their own initiative;
2. Where the products are announced to be no longer subject to management-system-based monitoring inspection;
3. Where the registration of quality management system was revoked or rescinded;
4. Where the registration scope of quality management system is changed and thus does not cover the products subject to management-system-based monitoring inspection;
5. Where violation is found against Article 6 or 8 of these Regulations;
6. Where a defect of the product subject to management-system-based monitoring inspection causes substantial damage to the consumers or endangers the public; or
7. Where the basic inspection facilities are revised, the production premises registered under these Regulations have not been equipped with the revised facilities within a given time limit in accordance with paragragh 2 of Article 2 of these Regulations.
8. Other serious violations of regulatory provisions or acts of making false and incorrect statements.