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The General Administration of Quality Supervision, Inspection and Quarantine issued the \"General Provisions for the Implementation of Industrial Product Production Licenses\"

2016-10-09View Original

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Big news! The General Administration for Quality Supervision, Inspection and Quarantine issued the \"General Rules for the Implementation of Production Licenses for Industrial Products\" – 2016-10-03, Quality and Certification. Recently, the administration announced the general rules for the implementation of production licenses for industrial products as well as detailed regulations for 60 categories of industrial products, which will come into effect on October 30th. In order to implement the requirements for administrative approval reform set by the State Council, further advance the reform of the system for industrial product production licenses, and standardize the issuance of such licenses, in accordance with the \"Regulations on the Administration of Industrial Product Production Licenses of the People’s Republic of China\" (State Council Order No. 440), the \"Implementation Measures for the Regulations on the Administration of Industrial Product Production Licenses\" (General Administration of Quality Supervision, Inspection and Quarantine Order No. 156), as well as the spirit of the \"Opinions of the General Administration of Quality Supervision, Inspection and Quarantine on Deepening the Reform of the System for Industrial Product Production Licenses\" (Guo Jia Zhi Jian [2015] No. 364), the General Administration of Quality Supervision, Inspection and Quarantine has formulated new \"General Provisions for the Implementation of Industrial Product Production Licenses\" and revised the implementation rules for 60 categories of industrial product licenses (excluding food-related products). The \"General Provisions for the Implementation of Industrial Product Production Licenses\" and the revised implementation rules for these 60 categories of licenses are now published and shall come into effect as of October 30, 2016. As of the date of implementation, the previously issued implementation rules and amendments shall become invalid. Provincial quality and technical supervision departments (market supervision and administration departments) are requested to implement these measures earnestly, and to strengthen the supervision and management of products for which certificates are issued as well as of the manufacturing enterprises involved, in accordance with the law. The full text of the \"General Provisions for the Implementation of Industrial Product Production Licenses\" is as follows: Chapter 1 General Provisions Article 1 These general provisions are formulated in accordance with the \"Regulations on the Administration of Industrial Product Production Licenses of the People’s Republic of China\" (hereinafter referred to as the \"Regulation Regulations\"), the \"Implementation Measures for the Regulations on the Administration of Industrial Product Production Licenses of the People’s Republic of China\" (hereinafter referred to as the \"Implementation Measures\"), various laws, regulations and rules such as the \"Implementation Measures for Administrative Licensing in Quality Supervision, Inspection and Quarantine\", as well as the requirements for administrative approval reform set forth in documents issued by the State Council, such as the \"Notice of the State Council on Standardizing the Administrative Approval Practices of State Council Departments and Improving Relevant Administrative Approval Procedures\" (State Council Document [2015] No. 6). Article 2 These General Provisions shall apply to matters such as the application, acceptance, examination, and decision regarding industrial product production licenses; they shall be used in conjunction with the corresponding implementation rules for product production licenses. These general provisions do not apply to food-related products. Article 3 The General Administration of Quality Supervision, Inspection and Quarantine (hereinafter referred to as the GAQSIQ) is responsible for the unified administration of industrial product production licenses. The National Office for Industrial Product Production Licenses (hereinafter referred to as the National License Office) is responsible for the day-to-day management of industrial product production licenses. The authorities in charge of industrial product production licenses in provinces, autonomous regions, and municipalities directly under the Central Government are responsible for overseeing and managing such licenses within their respective administrative areas. They handle the acceptance of applications from enterprises and conduct the review and approval process for production licenses regarding those products that are included in the list of products subject to the production license system (hereinafter referred to as the list). The provincial industrial product production license office is responsible for the day-to-day management of industrial product production licenses within its administrative jurisdiction. The competent departments for industrial product production licensing at the municipal and county levels are responsible for the supervision and management of production licenses within their respective administrative regions. Article 4 The National Industrial Product Production License Examination Center (hereinafter referred to as the National License Examination Center) is entrusted by the National License Office to carry out technical and administrative tasks related to production licenses. The National Industrial Product Production License Review Department (hereinafter referred to as the National License Review Department) is entrusted by the National License Office to carry out the technical tasks related to production licenses for relevant products. The national inspection agencies for issuing industrial product production licenses (hereinafter referred to as license-issuing inspection agencies) are entrusted by enterprises to carry out inspections on the samples submitted by those enterprises. The issuing inspection agency can be found on the website of the General Administration of Quality Supervision, Inspection and Quarantine. Chapter 2 Application and Acceptance Article 5 For an enterprise to obtain a production license, it must meet the following conditions: (1) It must have a business license that is appropriate for the production activities it intends to carry out ; (II) Having professional technical personnel suitable for the products produced ; (III) Have production conditions and testing methods suitable for the products manufactured ; (IV) There are technical documents and process documents suitable for the products produced ; (5) It has a sound and effective quality management system and responsibility system ; (VI) The product meets the relevant **standards, industry standards, as well as the requirements for ensuring human health and the safety of persons and property ; (7) It complies with the provisions of **industrial policies**, and there are no outdated production processes, as well as no situations involving high energy consumption, environmental pollution, or resource waste that are explicitly prohibited from use or investment in. Where other provisions exist in laws or administrative regulations, such provisions shall also be complied with. Article 6: Before applying, enterprises shall understand and master these general provisions, and make all necessary preparations prior to the on-site inspection in accordance with the requirements of the implementation rules for the production license of the product for which an application is being submitted. These preparations mainly include: (1) The enterprise information to be submitted to the review team ; (II) The enterprise shall maintain normal production operations during on-site inspections ; (III) The samples and sampling basis shall meet the requirements specified in the detailed rules for the production license of the product applied for. Article 7: When enterprises produce products listed in the catalog, they shall apply to the provincial-level authority responsible for issuing production licenses, or the lower-level authority designated by the province to handle such matters (hereinafter referred to as the provincial licensing authority), for a production license. The applications for production licenses cover situations such as issuance of licenses, renewal, changes to the scope of authorization, name changes, replacement of certificates, and withdrawal of applications. Article 8: Issuance of a license refers to situations where an enterprise submits an application for a production license for the first time, fails to meet the requirements for renewing the validity period of the production license and thus needs to apply for a new license, or submits an application for a production license after the expiration of the license’s validity period. In such cases, the enterprise shall submit the following application documents: (1) The “Application Form for National Industrial Product Production License” (see Attachment 1), in three copies ; (II) Copy or scanned copy of the business license (three copies) ; (III) Proof materials of industrial policies (if required). Article 9 Extension refers to the situation where an enterprise needs to continue production after the expiration of the validity period of its production license. The enterprise shall submit an extension application 6 months before the expiration of the license’s validity period, and must provide the following application documents: (1) The “Application Form for National Industrial Product Production License” (in three copies) ; (II) Copy or scanned copy of the business license (three copies) ; (III) Copy or scanned copy of the production license (three copies) ; (IV) Documentation supporting industrial policy (if required) ; (5) Other materials related to the renewal of the production license (three copies) ; For applications seeking exemption from on-site inspections, enterprises must submit the “Commitment Letter for Exemption from On-Site Inspection for Renewal of Enterprise Production License” signed by the legal representative/person in charge and stamped with the company seal (see Attachment 2), as well as a certificate issued by a quality and technical supervision department at or above the county level, attesting that no administrative penalties have been imposed during the validity period of the license ; 2. For applications for exemption from product inspection, enterprises shall submit certificates of successful quality supervision random inspections at the provincial level or above for products in the same category within 6 months (starting from the date of issuance of the inspection report). Article 10: Changes in the scope of licensing refer to situations such as changes in important production processes and technologies, key production equipment and testing equipment during the validity period of the production license, relocation of the production site, addition of new production sites, establishment of new production lines, or introduction of new products. In such cases, the enterprise shall submit the following documents: (1) The “Application Form for National Industrial Product Production License” (in three copies) ; (II) Copy or scanned copy of the business license (three copies) ; (III) Copy or scanned copy of the production license (three copies) ; (IV) Documentation supporting industrial policy (if required). Article 11: A change of name refers to a situation where, during the validity period of the production license, there is a change in the enterprise’s name, the name of its address, or the name of its production site, while the production conditions remain unchanged. In such cases, the enterprise shall submit the following documents: (1) The “Application Form for National Industrial Product Production License” (in duplicate) ; (II) Copies or scanned versions of the business license before and after the change (two copies in total) ; (III) Copy or scanned copy of the production license (two copies) ; (IV) In the case of a change in the company name, submit two copies or scans of the certification document issued by the administrative department for industry and commerce regarding the name change ; (5) In the event of a change in the name of the enterprise’s domicile or production address, a copy or scan of the certification document issued by the relevant administrative authority showing such change shall be submitted. (Two copies). Article 12: Reissue refers to the situation where, during the valid period of the production license, an enterprise applies to have its license reissued due to loss or damage. The following documents must be submitted: (1) The \"Application Form for National Industrial Product Production License\" (in two copies) ; (II) Copy or scanned copy of the business license (two copies) ; (III) The enterprise shall publish in publicly available newspapers and magazines an original statement of loss of the license, along with a copy or scan thereof. Article 13: When an enterprise applies for the renewal of its production license or a change to the scope of its licensing, and at the same time seeks a change in its name or the reissuance of its certificate, it shall submit the relevant documents in accordance with the requirements set out in Articles 9 to 12. Article 14: After accepting an application for an administrative license but before granting such license, if an enterprise applies to withdraw its application, it shall submit the following documents: (1) The \"Application for Withdrawing an Administrative License\" (see Attachment 3) (in two copies) ; (II) The original and copies or scanned versions of the “Decision on Accepting an Application for Administrative License”. Article 15: After receiving the application materials from enterprises, the provincial licensing authorities shall handle them according to the following circumstances: (1) If the matter applied for does not require an industrial product production license pursuant to laws, the authorities shall promptly inform the enterprise that the application will not be accepted ; (2) If the application does not fall under the authority of the production licensing authority according to law, it shall not be accepted; instead, a “Decision on Non-Acceptance” shall be issued ; (3) Where there are errors in the application documents that can be corrected on the spot, enterprises shall be permitted to make such corrections immediately ; (IV) If the application materials are incomplete or do not conform to the statutory requirements, the enterprise shall be informed, either on the spot or within 5 days from the date of receipt of the application, of all the items that need to be corrected. If no such notification is given within this time frame, the application shall be deemed accepted as of the date it was received ; (5) Where the application materials are complete and in compliance with the statutory format, or where all corrective materials have been submitted as required, a decision to accept the application shall be made immediately, and a “Decision on Acceptance of Application for Administrative Permission” shall be issued. (6) An enterprise does not qualify to apply under any of the following circumstances: 1. If an enterprise conceals relevant information or submits false materials when applying for a production permit, the administrative authority will reject the application or deny the administrative approval, issue a warning, and if the enterprise applies for a production permit again within one year ; 2. If an enterprise obtains a production license through improper means such as deception or bribery, and the administrative authorities impose administrative penalties in accordance with the law, and it applies for a production license again within three years ; 3. An enterprise whose production license has been revoked applies again within three years to obtain a production license for products listed in the same catalog ; 4. Where an enterprise applies to withdraw its production license, and re-applies for a production license within 6 months from the date of receiving a written notice from the administrative authority indicating the termination of the administrative licensing process. Article 16: In cases where the General Administration of Quality Supervision, Inspection and Quarantine issues the license, the provincial licensing authority shall, within 5 days as of the date of accepting the enterprise’s application, send the application materials submitted by the enterprise (in duplicate) to the National Licensing Review Department for the relevant products, as required. In cases where the application concerns only a name change, the reissue of a certificate, or the withdrawal of the application, the enterprise’s application documents (one copy) should be sent directly to the National License Review Center. Share to: Sina Weibo, WeChat, QQ friends and groups, Tencent Weibo, QQ Space. Favorite, Share, Like, Dislike. Follow the Security Professionals Blog—let’s build a home for security professionals together. Reply/Report. wxsunhao: http://bbs.anquan.com.cn/ucenter/avatar.php?uid=10922&size=middle. 3780 topics, 30,000 posts, 0 highlighted posts. Moderator. Veteran in the security field. 89,735 points. Registered on March 1, 2005. Last logged in on October 9, 2016. Send message. #2: http://bbs.anquan.com.cn/static/image/common/ico_lz.png. Original poster | Posted on October 8, 2016, at 18:15 | View only this author. Chapter 3: Review and Decision-Making. Article 17: Upon acceptance of an application for a production license, a review shall be conducted in accordance with the following requirements. The review of an enterprise includes on-site inspections as well as product testing for certification purposes. (1) The issuing authority shall conduct on-site inspections of the enterprise and carry out inspections for product certification ; (II) In the case of continuation, on-site inspections of the enterprise and product certification testing shall be conducted. If an enterprise submits a \"Commitment Letter for Exemption from On-site Inspection in the Application for Extension of the Enterprise Production License,\" on-site inspection will be waived. If a company submits a certificate stating that the products in the same category have passed quality inspection checks at the provincial level or above within 6 months, then it is exempt from having those products inspected for certification purposes ; (III) In cases where there is a change in the scope of permission, an on-site inspection of the enterprise and product certification testing shall be conducted. Where otherwise provided in the corresponding product implementation rules, such provisions shall prevail ; (IV) In cases of name changes, reissuance of certificates, and withdrawal of applications, no on-site inspections or product certification tests shall be conducted. Article 18: For cases approved by the General Administration of Quality Supervision, Inspection and Quarantine, upon receiving the application materials from enterprises, the National Licensing Review Department shall formulate a “Plan for On-site Verification of Enterprises” (see Annex 4, hereinafter referred to as the “Plan”). The Plan must be submitted promptly to the National Licensing Review Center. The National Licensing Review Department shall notify the enterprises three days in advance, and also send a copy of the notification to the provincial licensing authorities where the enterprises are located. As needed, the provincial licensing authorities may appoint observers to participate. Article 19: When conducting on-site inspections to verify production license compliance, attention should be paid to the professional competence of the inspectors; no fewer than 2 inspectors shall participate in each on-site inspection, and the inspection duration is generally 1–3 days. The members of the review panel shall not all come from the same organization. Article 20: The inspection team shall conduct on-site inspections in an objective and fair manner in accordance with these general provisions and the relevant implementation rules for specific products, keep proper records, prepare a report on the on-site inspection of the enterprise holding the production license, and inform the enterprise of the inspection results. The inspection team is responsible for the outcomes of these on-site inspections, with the team leader bearing ultimate responsibility. Article 21: Where an enterprise passes the on-site inspection, it shall seal samples as required by the implementation rules for relevant products; the enterprise may then independently choose a certification testing agency. The enterprise shall send the sample to the certification testing laboratory within 7 days from the date of sealing it. If on-site inspection is required, the enterprise shall contact the certification inspection agency to conduct the inspection on site. The company is responsible for the authenticity and accuracy of the samples. Article 22: If the on-site inspection of the enterprise fails, no further testing for product certification will be conducted, and the enterprise review process will be terminated. Article 23: In the case of continued exemption from on-site inspection, the enterprise shall, within 7 days from the date of acceptance, select samples in accordance with the requirements set out in the product implementation rules. The sampling form and seals must bear the enterprise’s seal, and both the sampling form and the samples should be placed in a box for sealing. The enterprise may choose an inspection agency to send the samples, while simultaneously sending the sampling form to the organization responsible for the review. The company is responsible for the authenticity and accuracy of the samples. For products exempt from certification inspection, no product sampling is conducted during on-site verification. Article 24: The certification inspection agency shall complete the product certification inspection within the time period specified in the product implementation rules, and issue an inspection report. Within 3 days from the date of issuance of the report, send 1 copy to the enterprise and 2 copies to the reviewing organization. Article 25: For those approved by the General Administration of Quality Supervision, Inspection and Quarantine, the National License Review Department shall, in accordance with relevant regulations, compile and review materials such as the enterprise’s application documents, on-site inspection records, and product certification inspection reports, issue review opinions, and submit the relevant materials to the National License Review Center within 20 days from the date of receiving the enterprise’s application. The National License Review Center shall complete the review of the submitted materials and submit them to the General Administration of Quality Supervision, Inspection and Quarantine within 25 days from the date it receives the enterprise’s application. Article 26 The General Administration of Quality Supervision, Inspection and Quarantine or the provincial licensing authority shall make a decision on whether to grant the license within 30 days as of the date of receiving the enterprise’s application. In cases where a decision to grant a production permit is made, the “Decision on Granting Permission” and the “Production Permit Certificate” shall be issued within 10 days from the date of the decision ; If a decision is made not to grant a production license, a \"Decision on Denial of Administrative License\" shall be issued to the enterprise within 10 days from the date of the decision, along with an explanation of the reasons. The applicant shall also be informed of their right to apply for administrative reconsideration or file an administrative lawsuit in accordance with the law. Article 27: Within 5 days from the date of making the administrative permission decision, the General Administration of Quality Supervision, Inspection and Quarantine shall send the relevant decision documents and certificates to the provincial competent authorities responsible for permits. The provincial competent authorities shall deliver these documents and certificates to the enterprises within 5 days of receiving them. Article 28: The General Administration of Quality Supervision, Inspection and Quarantine or the provincial licensing authorities shall, within 10 days as of the date of making the approval decision, publish the list of enterprises that have obtained the licenses to the public through the Internet or other means. Article 29 Under any of the following circumstances, the General Administration of Quality Supervision, Inspection and Quarantine or the provincial licensing authority shall decide to terminate the processing of the production license: (1) The enterprise delays, refuses, or fails to cooperate with the review without proper reasons ; (II) When an enterprise withdraws its application for a production license ; (III) The enterprise is terminated in accordance with the law ; (IV) The products for which the enterprise applies to produce are included in the **list of products to be phased out or prohibited from production** ; (5) Other circumstances under which the processing of a production license shall be terminated in accordance with the law. Chapter 4 Certificates and Marks Article 30 The validity period of a production license is 5 years. The starting date of the validity period is the date the approval decision is made, and the ending date is the day before the date of the approval decision five years later. In the event of any changes during the validity period (except for company relocation) or if it is reissued, the deadline remains unchanged. The start date of the extended validity period of the certificate is the day following the expiration date of the original certificate, and the end date is the same day five years after the expiration date of the original certificate. Article 31 The production license shall be issued in both an original and a copy, both of which have equal legal effect. The original and duplicate of the production license specify details such as the enterprise name, address, production location, list of products, certificate number, issuance date, validity period, and issuing authority; the duplicate also includes the main information of expired certificates. Digital certificates and text certificates for production licenses have the same legal validity. Article 32: The production license mark consists of the abbreviation “QS”, which is the pinyin of “Enterprise Product Production License” – QiyechanpinShengchanxuke – and the Chinese characters for “Production License”. The main color of the logo is blue; the letters “Q” and the four Chinese characters for “production license” are also blue, while the letter “S” is white. The production license mark is printed (attached) by the enterprise itself. It can be enlarged or reduced as specified. The production license number is composed of the uppercase Pinyin characters “XK” followed by a 10-digit Arabic numeral code: XK××-×××-×××××. Here, “XK” stands for license; the first two digits (××) represent the industry code, the middle three digits (×××) represent the product code, and the last five digits (×××××) represent the enterprise’s production license number. The production license issued at the provincial level has the abbreviation of the corresponding provincial administrative region added before the license number; the format of the code is (×)XK××-×××-×××××. Chapter 5 Group Companies Article 33 Group companies and their affiliated subsidiaries, branches, or production sites (hereinafter collectively referred to as affiliated entities) may apply for certification independently by those affiliated entities, or they may apply in the name of the group company in accordance with the provisions of this chapter. Article 34: When a group company and its affiliated units jointly apply for certification, it may be handled in the following manner: (1) For products for which certification is issued by the General Administration, affiliated units of group companies located in different provinces are allowed to apply for certification; the group company shall apply for a production license from the provincial administration where its headquarters is located. Provinces with special regulations must file a report with the General Administration ; (II) For products for which certification is issued by the provincial authorities and for which certification is sought in another province, each province formulates corresponding regulations based on its own actual conditions. Where it is permitted for the affiliated entity to operate across provinces, the provincial authority where the group company is headquartered shall delegate the task of review to the provincial authority where the affiliated entity is located, with the former issuing the certificate. Article 35 For enterprises that have obtained certifications in the form of a group company, the aforementioned provisions shall apply when handling matters such as the renewal of production licenses, changes to the scope of licensing, name changes, and reissuance of certifications. Article 36: In the case of obtaining a license in the form of a group company, the head office and its affiliated units share the same production license number. The affiliated units are issued only copies of the production license, which must be used alongside the original copy held by the head office. Article 37: In the case of obtaining certification in the form of a group company, the name of the group company, its address, production location, as well as the mark and number of the production license, together with the name, address, and production location of the affiliated entity, shall be indicated separately on its products or packaging and instructions. Chapter 6: The Principal Responsibilities and Obligations of Enterprises Article 38 In accordance with the Management Regulations, no enterprise shall produce products listed in the Catalogue subject to management under the production license system without obtaining a production license. No unit or individual shall sell or use in business operations products listed in the catalog that have not obtained a production license. Article 39 In accordance with the Administrative Regulations, when enterprises produce products listed in the catalog, they shall submit an application to the provincial competent authority for production licenses located in the place where the enterprise is situated. Article 40 In accordance with the Regulatory Provisions, enterprises that wish to renew their certificates, change the scope of their permits, alter their names, or obtain replacement certificates shall submit applications in a timely manner to the provincial competent authority for production licenses in the location of the enterprise, as required by regulations. Article 41 In accordance with the Implementing Measures for Administrative Licenses in Quality Supervision, Inspection and Quarantine, enterprises that have obtained a production license shall ensure that the product quality remains stable and compliant, and continue to meet the conditions required for such a license, while cooperating at all times with the authorities responsible for overseeing production licenses to carry out inspections and supervision in accordance with the law. Article 42 In accordance with the Administrative Regulations, if, during the validity period of the production license, an enterprise ceases to engage in the production of products listed in the catalog, it shall go through the procedures for canceling the production license. Article 43 In accordance with the Management Regulations, enterprises that have obtained a production license shall complete the marking of the production license symbol and number on their products, packaging, or instruction manuals within 6 months from the date the license is granted. For bare products whose characteristics make it difficult to provide labeling, labeling may be omitted. Article 44 In accordance with the Management Regulations, no entity or individual shall forge or alter production license certificates, production license marks, or numbers. No entity or individual shall misuse another person’s production license certificates, production license marks, or numbers. Article 45 In accordance with the Management Regulations, enterprises that have obtained a production license shall not lease, lend, or transfer the production license certificate, the production license mark, and the license number in any other form. Article 46 In accordance with the Administrative Regulations, enterprises shall not obtain production licenses through improper means such as deception or bribery. Article 47 In accordance with the Implementation Measures, enterprises may commence trial production of the products for which certification is applied as of the date the application is accepted. Products manufactured in trial production by a company must pass factory inspection, and the words “Trial Product” must be indicated on the product or its packaging and instructions before they can be sold. If the General Administration of Quality Supervision, Inspection and Quarantine or the provincial authority responsible for issuing licenses decides to terminate the licensing process or deny the license, the enterprise shall cease trial production of that product effective immediately. Article 48 Where other provisions are set forth in laws or administrative regulations, such provisions shall also be complied with. Chapter VII Supplementary Provisions Article 49 The time limits specified in the general provisions of these implementation rules are calculated based on working days, excluding statutory holidays and product inspection times. Article 50 The approval and issuance of certificates, which are the responsibility of the provincial quality and technical supervision departments, shall be carried out in accordance with the provisions of these general rules. Article 51 These general provisions of the implementation rules shall be interpreted by the **General Administration of Quality Supervision, Inspection and Quarantine. Article 52 These general provisions of the implementation rules shall come into force on October 30, 2016.

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