機械設備器具監督管理辦法

These Regulations are established in accordance with Paragraph 4, Article 7,Paragraph 5, Article 8 and Paragraph 4, Article 9of the Occupational Safety and Health Act (the Act).

1The terms and vocabulary used in these Regulations shall be defined as follows:

21. Product surveillance: for products specified in Paragraph 1 or 3, Article 7 or Paragraph 1, Article 8 of the Act, to perform inspection of sampled products, check completeness of production and distribution records and ensure consistency of safety specifications at the manufacturing stage at the production premises or warehouses.

32. Market checks: for products specified in Paragraph 1 or 3, Article 7 or Paragraph 1, Article 8 of the Act, to perform sampling tests, inspection or investigation at places of distribution, production premises, warehouses, working areas, business sites or other places.

Manufacturers, importers, suppliers and the responsible persons of places mentioned in subparagraph 2 of the preceding Article (hereinafter referred to as the person subject to inspection) shall not evade, impede or refuse the checks, investigation, inspectionor seal of products without justified reasons.

1The central competent authority, labor inspection bodies and type certification bodies mentioned in Paragraph 1, Article 8 of the Act may inspect or investigate purchased or sampled products, if it is so required in order to carry out their activities.

2The central competent authority may commission, in accordance with Article 52 of the Act, professional groups to purchase or sample products from the market required for market checks.

1The type certification body shall have an annual implementation plan based on the risk level of the products it certifies.

2The 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.

3The 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.

1To 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:

21. Surveillance on products: including sampling inspection and checking of the production and distribution records.

32. 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.

4The type certification body shall make product surveillance records of the surveillance mentioned in the preceding paragraph and maintain them properly.

1The 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.

2Where 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.

1Under 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:

21. Where there are no testing facilities at the surveillance place;

32. Where there are discrepancies as a result of the on-site comparison or testing; or

43. Where there are doubts requiring further clarifications.

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.

1Where 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.

2The type certification body shall conduct market checks to follow up the status of recall after the time limit expires.

1For 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.

2The production and distribution documents concerning products mentioned in the preceding paragraph have to include the following items.

31. Dates of manufacture.

42. Types, specifications, quantities.

53. Dates of shipment.

64. Clients.

75. Complaints records and service records.

8Manufacturers or importers shall maintain the production and distribution documents concerning products mentioned in Paragraph 1 for at least 10 years from the date the products were registered at the Safety Information Reporting Website or granted certificates of type certification and keep them available for non-periodic checks by the central competent authority or labor inspection bodies, and the retention periods of production and distribution documents concerning such products shall be extended with the extended validity period of the products as registered at the Safety Information Reporting Website or granted certificates.

1The central competent authority or labor inspection body may conduct market checks as a result of any of the following reasons:

21. Accusations made by informants, workers or labor groups,

32. Disasters or incidents caused by products that are likely to damage the life, body, health or properties of workers, or

43. Other information resources indicating that the conduction of market checks is considered necessary.

1The following items shall be included in market checks:

21. Compliance of the product with the requirements of Paragraphs 1 and 3, Article 7,

32. Compliance of the product with the requirements of Paragraph 1, Article 8,

43. Compliance of the safety labels or certification labels, in terms oftheir patterns and manners of posting, with the requirements specified in the regulations,

54. Completion of corrective actions within the specified time limit for violating products,

65. Recall of violating products within the specified time limit, and

76. Violations of laws by manufacturing and shipping out of the production premises, importing, renting, supplying or installing productsof which the registered information or type-certified qualification is cancelled, rescinded or withdrawn.

8The central competent authority or labor inspection body may notify the person subject to inspection to provide certificate of type certification, test reports, technical files, testing samples or other supporting documents during market checks.

1The inspector performing market checks shall present identification documents to the person subject to inspection and explain the basis and reasons of the checks.

2The person subject to inspection shall be present or assign representative to accompany the inspector during market checks.

3The inspector shall make inspection records after completing market checks and have the person subject to inspection sign or seal stamps on the inspection records.

1The central competent authority or the labor inspection body shall investigate on products that are likely to violate related regulations when it performs market checks.

2The means of investigation shall be:

31. To make inquiry to the person subject to inspection or related persons and request for supply of relevant supporting documents,

42. To investigate at the site mentioned in subparagraph 2, Article 2 and sample products that are likely to violate related regulations for inspection, or ask the person subject to inspection to provide products that are of the same type with suspect products for testing, and

53. To seal products that are likely to violate regulations, where necessary, and put the products in the custody of the person subject to inspection or deliver the products to designated places after the person subject to inspection draws up proof documents or affidavit concerning the status of these sealed products.

1When conductingthe investigation mentioned in the preceding Article, the inspector shall make interview records on the site of theinvestigation or ondesignated places where the products are stored. Comments or explanations made by the person subject to inspection shall be noted in the records.

2The person subject to inspection shall keep shipment-return documents for later checks when delivering products likely to violate regulations to designated places for storage.

The person subject to inspection or the designated representative shall not evade, impede or refuse market checks without justified reasons.

1The inspector shall make records on market checks if the person subject to inspection evade, impede or refuse checks without justified reasons.

2The records mentioned in the preceding paragraph shall include the following items:

31. Name, office or business place of the person subject to inspection, and the name, date of birth, gender, personal identification number and address of domicile of the responsible person or representative,

42. Reasons of evasion, impediment or refusal of checks and the whole course of the situation,

53. The body and person performing checks, and the time and place of checks,

64. Other items for collecting evidence.

7Where the information on the person subject to inspection is not available, the inspector may make inquiry to related government agencies and record it at a later time.

The central competent authority or labor inspection body finding noncompliant products during market checks of type-certified products shall inform the type certification body that issue the certificate to investigate reasons of noncompliance, make interview reports and process the case in accordance with related requirements.

1The central competent authority, labor inspection body and typecertification body mentioned in Paragraph 1, Article 8 of the Act shall follow up products not in compliance with safety standards, and carry out investigations to the manufacturer, importer or supplier and make interview reports.

2For products mentioned in the preceding paragraph that are considered not safe, the organization or body mentioned in the preceding paragraph shall prepare a notification document stating the basis of regulations, reasons of notification, name of products, type, date of manufacture/import and name of manufacturer/importer, with supporting photos.

3The labor inspection body or type certification body shall sent the investigation documents, interview reports and notifications of unsafe products mentioned in the preceding two paragraphs to the central competent authority.

4The central competent authority shall process and keep the investigation documents, interview reports and notifications of unsafe products mentioned in the preceding paragraph in accordance with related regulations.

1Where the person subject to inspection evade, impede or refuse investigation without justified reasons, the inspector shall make a record and sent it to the central competent authority, labor inspection body or type certification body mentioned in Paragraph 1, Article 8 of the Act to process in accordance with related regulations.

2The provisions of Paragraphs 2 and 3 of Article 18 shall apply mutandis mutatis to the content of the record mentioned in the preceding paragraph.

The central competent authority may request assistance from the Customs to perform border inspection of products that do not comply with safety standards during purchased or sampled inspection and are likely to pose hazards to the safety of workers.

1If the products that fail inspection cannot be further modified to meet the safety standards, the obligatory applicant shall return the shipment, destroy or disassemble the products, or adopt other necessary measures within six months after receiving an a notice of noncompliance.

2When actions mentioned in the preceding paragraph are taken to dispose of products, the obligatory applicant shall apply to the central competent authority for opening the seal, or may open the seal themselves, after obtaining an approval from, and under the supervision of, the central competent authority, labor inspection body and type certification body mentioned in Paragraph 1, Article 8 of the Act.

3For products that are to be returned as mentioned in the first paragraph, theobligatoryapplicant shall report to the central competent authority to close the case by providing documents related to export or crosschecking the information on returned shipment with the Customs within three months after the products are returned.

1Sampled products that fail inspection shall be taken back by the obligatory applicant within three months after receiving the notice of noncompliance. Where the sampled products are not taken back by the obligatory applicant after three months, the central competent authority, labor inspection body and type certification body mentioned in Paragraph 1, Article 8 of the Act may destroy the products, dissemble the products to unusable status or take necessary actions.

2The fees evolved from actions taken by the central competent authority, labor inspection body and type certification body mentioned in Paragraph 1, Article 8 of the Act to destroy the products, dissemble the products to unusable status or othernecessary dispositions shall be borne by the obligatory applicant.

1The obligatory applicant shall observe the following requirements for imported or manufactured products that need to be returned or destroyed because they fail inspection:

21. Return shipment: to provide the central competent authority with copies of export related documents to close the case or crosscheck information on return shipment with the Customs to close the case within three months after the products are returned.

32. Destruction: to apply to the central competent authority by presenting a destruction plan, destroy products and request for closing the case.

1When accepting applications for destroying products as mentioned in subparagraph 2 of the preceding Article, the central competent authority shall review the content of destruction plan, including serial number of the application, name of products, specifications, quantities, place of destruction, means of destruction and subsequent disposition of wastes, etc.

2The central competent authority approves the destruction plan mentioned in the preceding paragraph may dispatch personnel or commission other organizations/bodies to witness the destruction and take photos or video recording the critical processes for documentation. Where the process of destruction does not comply with that stated in the destruction plan, destruction shall be stopped and carried out at a later time after correction is made by the obligatory applicant upon receipt of notice from the central competent authority.

The personnel witnesses the destruction shall confirm that the products are destroyed to unusable status after completion of the destruction and note down the checks and date of destruction on the destruction report, which shall be sent to the central competent authority for closing the case. A copy of the destruction report and related documents shall be kept for subsequent checks.

The verification bodies recognized by the central competent authority which perform product surveillance and processing of noncompliant products as prescribed in Paragraph 1 or 3, Article 7 of the Act shall apply mutatis mutandis to the regulations related to type certification body in Chapter 2 and 4.

1These Regulations shall take effect on January 1, 2015.

2The amended articles of the Regulations shall take effect on July 1, 2026.