Article 3
The following commodities shall be inspected in accordance with this Act as long as the categories, the items, and/or the shipping destinations of such commodities have been so designated and made known to the public by the BSMI per public notice:
1. Agricultural, industrial and mining commodities domestically manufactured, including those produced, manufactured or processed;
2. Agricultural, industrial and mining commodities to be exported; or
3. Agricultural, industrial and mining commodities to be imported.
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Article 4
The technical activities of inspection are conducted by the BSMI, and may be conducted by any relevant government agencies (bodies), juristic persons or organizations on behalf of the BSMI as entrusted by the BSMI.
The BSMI may commission any relevant government agencies (bodies), juristic persons or organizations to perform the operations in connection with the issuance of inspection certificates (new or replacement) and to conduct relevant inspection activities.
The expenses pertaining to the entrusted or commissioned inspection mentioned in the preceding two Paragraphs may be accordingly deducted from the commodity inspection fees.
Regulations governing the qualification, review, supervision, performance evaluation and other requirements of relevant government agencies (bodies), juristic persons or organizations so commissioned by the BSMI under Paragraph Two of this Article shall be prescribed by the competent authority.
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Article 5
Commodities inspection shall be conducted in four schemes, namely batch-by-batch inspection, monitoring inspection, registration of product certification, and declaration of conformity.
Inspection schemes applicable to different commodities shall be designated and made known to the public by the BSMI per public notice.
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Article 6
No commodities subject to inspection shall be released from the production premises, nor be exported or imported, if it does not conform to the inspection requirements. However, commodities identified by the BMSI as low risk of hazard may be exempted from this restriction.
Commodities as mentioned in the Proviso of the preceding Paragraph shall still comply with the inspection requirements before they are placed on the market.
The criteria for identification of risks of hazard as mentioned in the Proviso of Paragraph One of this Article, the assessment procedure, analysis and application, as well as guidelines for other matters shall be prescribed by the competent authority.
Sellers shall not display or sell commodities subject to inspection that do not comply with the inspection requirements.
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Article 8
The following persons shall be obligated to file applications for commodities inspection (hereinafter referred to as the obligatory inspection applicant):
1. The manufacturer or exporter of a commodity involved if it is manufactured domestically. For commodities that are entrusted to be manufactured and sold or exported under the name of the entrusting person who has a domicile or business place in the Republic of China (Taiwan), the entrusting person shall be the obligatory inspection applicant.
2. The importer of a commodity involved if it is manufactured overseas. For commodities that are entrusted to be imported and sold domestically under the name of the entrusting person who has a domicile or business place in the Republic of China (Taiwan), the entrusting person shall be the obligatory inspection applicant.
3. The seller of a commodity involved in case the manufacturer, exporter/importer or the entrusting person of manufacturing, export or import is unknown or cannot be located.
The manufacturer as mentioned in the preceding Paragraph may be referred to either of the following parties:
1. The assembler: for commodities assembled for sale from individual parts and components; or
2. The modifier: for commodities conforming to the inspection requirements and modified for the purpose of sale before being placed on the market.
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Article 9
Under any of the following circumstances, the commodity subject to inspection may be exempted from inspection:
1. Where the imported commodity is attached with an inspection certificate issued by the government of the country of origin of the commodity which provides a reciprocal inspection exemption treatment to the commodities of the Republic of China;
2. Where the commodity is exported from or imported to the Republic of China for personal use by any member of a foreign embassy or consulate located in the Republic of China or by any person who is entitled to diplomatic immunity;
3. Where the products not for sale, such as products for own-use, commercial samples, products for exhibition, or articles for use in research and development or in testing activities are imported or exported;
4. Where the imported or domestically manufactured commodities are intended to be exported after further processing or assembly or where the imported commodities are intended to be exported in its original form;
5. Where the imported or domestically manufactured parts or components of commodities subject to inspection are required for processing or assembly for the finished product(s) and will be inspected in its entirety as a finished product(s) in accordance with the same inspection standards applicable to such finished product(s);
6. Where the imported or domestically manufactured commodities are intended to be used by the military authority with the official letter proof issued by the various authorities under the direct supervision of the Ministry of National Defense; or
7. Where the imported or domestically manufactured commodities are intended to be used for the emergency humane rescue with relevant government proof papers.
Regulations governing the requirements, approval and refusal, labeling of usages, close of cases, extension, alteration of usages, checks and evaluation for filing an inspection exemption application under the preceding Paragraph, and other compliance matters shall be prescribed by the competent authority.
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Article 10
Inspection items and inspection standards of commodity shall be made known to the public per public notice by the BMSI.
The commodity inspection standards referred to in the preceding Paragraph shall be determined and identified by the BMSI in accordance with the obligations required by international conventions, and in reference to national standards, international standards and/or other applicable technical regulations, or shall be developed by the BSMI in the absence of such national standards, international standards, or other technical regulations.
In case the specifications of an exported commodity are inconsistent with official inspection standards, an inspection may be conducted in accordance with the standards agreed upon between the buyer and the seller thereof, with prior approval of the competent authority in charge of trade.
In case the specifications of an imported or domestically manufactured commodity are inconsistent with the official inspection standards for a specific reason, such reason shall be reported to and approved by the BSMI in advance.
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Article 12
The obligatory inspection applicant shall place the commodity inspection mark on the commodity’s body provided; however, that the body of the commodity is too small or for other specific causes to accommodate such mark, the commodity inspection mark may be affixed to the commodity in accordance with other marking methods, except for those commodities which are designated or approved to be exempted from bearing the commodity inspection mark by the BSMI.
Regulations governing the design, identification number, labeling method, printing, pre-purchase, report, check, cancellation and use of the commodity inspection mark as required in the preceding Paragraph of this Article, and other compliance matters shall be prescribed by the competent authority.
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Article 13
The BSMI may recognize the designated testing laboratories to conduct the testing of commodities subject to inspection.
Regulations governing the qualification requirements, conditions, application procedures and assessment of the designated testing laboratories, and the term of validity, the issuance/revocation/rescission of the certificate (new or replacement), and relevant administrative matters shall be prescribed by the competent authority.
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Article 17
In order to make the best use of inspection resources and provide technical services, the BSMI may accept the request of any manufacturer or firm to provide, in accordance with a commissioning arrangement, product testing service or other technical services. Regulations governing the commissioning procedures, testing, retesting, sample treatment and other compliance matters shall be prescribed by the competent authority.
When the testing report of the commodity so commissioned under the preceding Paragraph is used in the labeling, advertisement or other promotion activities of the commodity, information on the name of the commodity, specification, type, testing items, testing results, the way by which samples are provided and other notices as presented in the testing report shall also be noted and the wording of the labeled information shall not be misleading in a manner that would indicate that the BSMI has inspected and approved the commodity.
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Article 28
In order to enhance inspection efficiency, the BMSI may make known to the public per public notice that a type approval application shall be filed in advance and a type approval certificate shall be obtained for a specific commodity before the filing of an inspection application, and may, for that specific commodity, simplify the inspection procedures when an inspection application is filed.
Under any of the following circumstances, the commodity may be exempted from type approval and an inspection application may be filed directly for such commodity. A certificate shall be issued after the relevant documents submitted along with the application have been verified to be in accord with the requirements and a letter of undertaking has been made by the obligatory inspection applicant to assure its completion of the procedures to close the case within a specific period of time:
1. Where the commodity is required for use in testing;
2. Where the commodity is re-imported after having been repaired abroad; or
3. Where the commodity is needed for making emergency repair or maintenance.
Regulations governing the requirements and procedures for filing a type approval application, the period of validity, the issuance/revocation/rescission of the type approval certificate (new or replacement), the examination of a direct inspection application, the procedure for filing the letter of undertaking, the procedure and manner for closing cases, the issuance/revocation/rescission of the certificate (new or replacement), and other compliance matters as required in the preceding two Paragraphs shall be prescribed by the competent authority.
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Article 31
A commodity subject to monitoring inspection may be exported or imported only when the management and inspection systems of the production premises thereof have been examined to comply with the requirements of provisions.
In case the production premise set forth in the preceding Paragraph is located abroad, a letter of recommendation of such production premises issued by the competent authority or an inspection organization recognized by the BSMI, either being located in the same country of such premise, shall be required. In addition, the BSMI may send its representative to make an on-site survey at such premise.
Regulations governing the qualification requirements of the production premises set forth in the preceding two Paragraphs, the procedure for filing an application for examination of production premises, and relevant administrative matters shall be prescribed by the competent authority.
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Article 32
Regulations governing the registration, procedures for filing monitoring inspection applications, the implementation methods, the issuance of certificates (new or replacement), and other compliance matters shall be prescribed by the competent authority.
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Article 33
For a commodity subject to monitoring inspection as designated and made known to the public by the BMSI per public notice, where the management system of the production premises and inspection system comply with the requirements established by the BSMI after examination and approval, the manufacturer of the commodity concerned may perform the inspection on its own in accordance with this Act and issue, with counter-signature, monitoring inspection certificates and submit periodically the certificate issuing records to the BSMI. For the production premises of commodity concerned located outside the territory of the Republic of China, the obligatory inspection applicant shall submit the inspection records to the BSMI for approval before issuing the monitoring inspection certificates.
Regulations governing the requirements for production premises, the application procedure of the approval, suspension/revocation/rescission and other compliance matters mentioned in the preceding Paragraph shall be prescribed by the competent authority.
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Article 35
Commodities subject to registration of product certification shall meet the requirements set forth in the conformity assessment procedures prescribed under Article 37 of this Act.
The conformity assessment procedures shall include the requirements in the design and manufacturing stages of commodities.
The conformity assessment modules or the combination of such modules applicable to various categories of commodities shall be made known to the public by the BMSI per public notice.
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Article 40
Where a commodity is granted registration, it shall be used in accordance with the scope, type or function specified in the product registration certificate. The certificate shall not be used for commodities that are beyond the scope of the certificate. If any alteration has been made to a commodity that has been granted a product registration certificate, a new application, or an application made for series of the same type, or an application for approval of such alteration shall be filed by the applicant concerned.
Where the inspection standards of commodities that have been granted registration of product certification are revised, for purposes of safety, health, environmental protection, efficiency of resource utilization or other public interests, the BSMI may notify the certificate holder to apply for replacing the certificate to conform to the revised standards within a given time limit.
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Article 41
Where the registration was acquired through fraudulent means, such registration shall be revoked and the registration certificate is required to be returned within a given time limit.
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Article 42
Under any of the following circumstances, the registration of product certification made shall be rescinded:
1. Where the commodities purchased or sampled are inspected to be not in conformity with the inspection standards;
2. Where the commodity was not marked in the manner as required in Articles 11 and 12 of this Act, and the required correction has not been made within a given time limit after receipt of notice;
3. Where the company of the registered product, without good cause shown, has refused or failed to provide, within a given time limit, the registration certificate, technical documents or samples as required;
4. Where the defect in the registered product has caused severe injury to any person or endangered public safety;
5. Where the product registration certificate was not used in compliance with Paragraph One of Articles 40 of this Act, and the required correction has not been made within a given time limit after receipt of notice;
6. Where the registered production premises failed to meet the conformity assessment procedures at manufacturing stage;
7. Where the procedural (annual) fees due were not paid, and have further been not paid within the given time limit;
8. Where the announcement of a commodity subject to registration of product certification has been rescinded by a public notice; or
9. Where the registration certificate was not replaced to be in conformity with the revised inspection standards within a given time limit in accordance with Paragraph Two of Article 42.
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Article 43
The obligatory inspection applicant shall prepare relevant technical documents to assure that the commodity conforms to the inspection standards, and shall, based on such technical documents, execute and issue a declaration of conformity.
The requirements to be met by and essential elements to be contained in the technical documents and the declaration of conformity shall be made known to the public per public notice by the BSMI in respect of various categories of commodities.
For commodities that are identified by the BSMI as high risk of hazard, the obligatory inspection applicant shall be registered with the BSMI by following related provisions before the declaration of conformity it issued becomes valid.
Where the inspection standards of commodities described in declaration of conformity are revised, for purposes of safety, health, environmental protection, efficiency of resource utilization or other public interests, the BSMI may notify, by public notice, the obligatory inspection applicant to issue a new declaration of conformity based on the revised inspection standards within a given time limit.
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Article 45
For a commodity described in a declaration of conformity, the manufacturer thereof shall adopt control measures during the manufacture thereof to ensure that the product conforms to the specifications set forth in the technical documents. The quality of such products shall be consistent with that of the samples used in the testing described in the test reports annexed to the technical documents.
Upon the issuance of a declaration of conformity, a commodity shall conform to the content of the declaration. In case the commodity is altered, the obligatory inspection applicant shall execute and issue a new declaration to ensure the conformity of the commodity with the inspection standards.
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Article 47
Under any of the following circumstances, a declaration of conformity shall be deemed not made:
1. Where no technical document has been prepared in accordance with the provisions of Paragraph One of Article 43 of this Act, or no testing application has been filed with the BSMI or the designated testing laboratories recognized by the BSMI in accordance with the provisions of Article 44 of this Act; or
2. Where a declaration of conformity or a technical document is found to contain false or incorrect information. or incompliance with the provisions of Paragraph Two of Article 43 of this Act.
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Article 48
Under any of the following circumstances, the declaration of conformity made under this Act shall become null and void:
1. Where the commodities purchased or sampled are inspected to be not in conformity with the inspection standards;
2. Where the commodity was not marked in the manner as required in Articles 11 and 12 of this Act, and the required correction has not been made within a given time limit after receipt of notice;
3. Where the obligatory inspection applicant refused or failed to provide a declaration of conformity, the relevant technical documents or samples without good cause shown or within a given time limit;
4. Where the declaration of conformity was not used in accordance with the content of declaration, and the required correction has not been made within a given time limit after receipt of notice;
5. Where the announcement of a commodity to be subject to inspection has been rescinded or the inspection scheme of declaration of conformity is announced to be no longer applicable to a commodity per public notice;
6. Where the required correction was not completed within a given time limit after receipt of the notification of the revision of inspection standards in accordance with the provisions of Paragraph Four of Article 43 of this Act; or
7. Other serious violations of regulatory provisions.
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Article 49
In order to ensure the conformity of commodities to the provisions of this Act, the BSMI may send its representative to the following places to conduct a check of the commodities subject to inspection:
1. the place of display and sale of commodities;
2. the production premises or storage places where the commodities subject to inspection are produced or stored; or
3. places of business, work place, or other places whereat the commodities are installed or being used.
In order to conduct the check described in the preceding Paragraph, the BSMI may require the responsible person(s) of such place(s) to provide relevant information, and may further require the obligatory inspection applicant to submit relevant inspection certificate(s), technical documents and samples for use in conducting the verification or testing.
Regulations governing the targeted group subject to check, the method and scope of check, the disposal of law-violating commodities and relevant matters set forth in the preceding two Paragraphs shall be prescribed by the competent authority.
Where incidents with commodities subject to inspection have caused damage to the life, body, health or property of consumers, or have damage concerns, the obligatory inspection applicant shall notify the BMSI. Regulations governing the time point, method, content of the notification and other compliance matters shall be prescribed by the competent authority.
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Article 52
The BSMI may select and engage, on its own or as recommended by consumers’ protection organization(s), volunteers to assist in uncovering law-violating commodities.
Regulations governing the selection and engagement of volunteers set forth in the preceding Paragraph, the procedures for uncovering law-violating commodities, and other relevant administrative matters shall be prescribed by the competent authority in consultation with relevant government agencies.
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Article 59
The obligatory inspection applicant of a commodity subject to inspection who violated the provisions governing the labeling of commodity as set out in Article 11 or Article 12 of this Act and who has further failed to correct the violation within the given time limit as required after receipt of notice shall be imposed with a fine in an amount of not less than New Taiwan Dollar One Hundred Thousand (NTD 100,000), but not more than New Taiwan Dollar One Million (NTD 1,000,000).
The obligatory inspection applicant of a commodity subject to inspection who has made false or incorrect labeling on such commodity shall be imposed with a fine in an amount of not less than New Taiwan Dollar One Hundred Fifty Thousand (NTD 150,000), but not more than New Taiwan Dollar One Million Five Hundred Thousand (NTD 1,500,000).
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Article 60
Under any of the following circumstances, the obligatory inspection applicant of a commodity subject to inspection shall be imposed with a fine in an amount of not less than New Taiwan Dollar Two Hundred Thousand (NTD 200,000), but not more than New Taiwan Dollar Two Million (NTD 2,000,000):
1.Having violated the provisions of Paragraph One or Paragraph Two of Article 6 by releasing from the production premises or exporting or importing or placing on the market, any commodity that do not conform to the inspection requirements;
2. Having violated the Paragraph One of Article 7 which prohibits the release of any commodity from the storage place;
3. Having violated Article 27 regarding a new application for inspection, Paragraph One of Article 40 regarding a new application for registration, or Paragraph Two of Article 45 regarding a new declaration;
4. Having acquired the inspection certificate through fraudulent means;
5. Having failed to apply for cancellation of original records within a specific period of time as required by Paragraph Two of Article 28 hereof.
6. Having failed to comply with the requirement set out in Subparagraph One of Article 47, or making false statements prohibited by Article 41 or Subparagraph Two of Article 47 hereof.
Under any of the circumstances set forth in the preceding Paragraph and upon failure of the commodity to pass the inspection, the obligatory inspection applicant shall be imposed with a fine in an amount of not less than New Taiwan Dollar Two Hundred Fifty Thousand (NTD 250,000), but not more than New Taiwan Dollar Two Million Five Hundred Thousand (NTD 2,500,000).
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Article 63
The obligatory inspection applicant who has violated the provisions of notification as set out in Paragraph Four of Article 49 of this Act shall be imposed with a fine in an amount of not less than New Taiwan Dollar Ten Thousand (NTD 10,000), but not more than New Taiwan Dollar One Hundred Thousand (NTD 100,000).
Under any of the circumstances set forth in Paragraph Two of Article 59, Article 60 or Article 61 of this Act, the obligatory inspection applicant may be notified to recall or correct the commodities within a given time limit, and may further be ordered to discontinue the export, import, production, manufacture, display or sale of the commodity at issue within a given time limit.
Having failed to recall or correct commodities within the given time limit as set forth in the preceding Paragraph, the obligatory inspection applicant shall be imposed with a fine in an amount of not less than New Taiwan Dollar One Hundred Thousand (NTD 100,000), but not more than New Taiwan Dollar One Million (NTD 1,000,000), and may further be fined each time for his successive violation of the same nature.
Having failed to discontinue the export, import, production, manufacture, display or sale of the commodity within the given time limit as set forth in Paragraph Two of this Article, the obligatory inspection applicant shall be imposed with a fine in an amount of not less than New Taiwan Dollar Two Hundred Fifty Thousand (NTD 250,000), but not more than New Taiwan Dollar Two Million Five Hundred Thousand (NTD 2,500,000), and may further be fined each time for his successive violation of the same nature.
Upon finding any violations as set forth in Paragraph Two of this Article, the commodity at issue may further be confiscated and destroyed, or subject to other necessary and appropriate measures.
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