Q1: What special equipment exporting into China need the approval and shall get the Chinese Manufacture License (ML)? A1: International special equipments are subjected to ML refer to boilers, pressure vessels, safety valves, bursting Discs, Valves of gas cylinders. The special equipment shall follow the stipulation of supervision administration regulation for manufacture of boiler and pressure vessel.
Q2: Which aspect SESA, SELO and CSEI are responsible for respectively in the field of special equipment manufacture licensing? A2: Special Equipment Safety Administration Bureau (SESA), AQSIQ: is the authority in charge of special equipment manufacture licensing. Its main responsibilities include acceptance of manufacture licensing applications, approval of appraisal and assessment reports, issuance and management of manufacture licenses.Special Equipment Licensing Office (SELO), AQSIQ: is an office established by SESA to deal with daily routines of manufacture licensing. Its main responsibilities include reception of application documents and appraisal and assessment reports, printing and mailing of licenses, reception of Data Notice from overseas license holders, providing consultation for manufacture licensing procedures, policies and regulations. China Special Equipment Inspection and Research Institute (CSEI): is an appraisal and assessment organization for manufacture licensing authorized by AQSIQ. Its main responsibilities include organizing the appraisal and assessment team, making the appraisal and assessment schedule, carrying out the on-site appraisal and assessment, and drafting the appraisal and assessment report. Note: “appraisal and assessment” hereinafter will be idiomatically substituted by “audit”.
Q3: What’s the main contents for on-site audit (appraisal and assessment)? A3: Resources requirements: The manufacturer shall possess the necessary resources and capability required for the manufacturing of its products and the applied product level, including production site, manufacturing and processing facilities, inspection and test equipment and conditions as well as the suitable and appropriate human resources. For details, please refer to the Requirements for Boiler and Pressure Vessel Manufacture Licensing. Quality management system requirements: A quality management system shall be established and operate effectively according to TSG Z0004-2007 Basic Requirements for Special Equipment Quality Assurance System on Manufacture, Installation, Alteration and Repair. Product safety quality requirements: the design and manufacture of boiler and pressure vessel products to be manufactured and/or used inside China shall be subject to Chinese codes and standards. For details, please refer to relevant safety technical codes and standard, TSG G0001-2012 Boiler Safety Technical Supervision Administration Regulation and R0004-2009 Supervision Regulation on Safety Technology for Stationary Pressure Vessel.
Q4: How to acquire the codes and regulations related to manufacture licensing? A4: The relevant safety technical codes and regulations can be downloaded from SELO’s website http://www.cbpvi.org/laws.html. The codes and regulations which are not published on the website, should be purchased from the Periodical Office of China Special Equipment Safety. Tel: +86 10 59068615 Email: zzs@.csei.org.cn
Q5: How to classify the level for Manufacture License of pressure vessel? A5: Firstly, confirm the category of the pressure vessel according to pressure and volume graph in ANNEX A, Supervision Regulation on Safety Technology for Stationary Pressure Vessel (TSG R0004-2009); secondly, confirm the level of the pressure vessel according to Attachment 1 of Supervision Administration Regulation for Manufacture of Boiler and Pressure Vessel.
Q6: What procedure shall be covered if the foreign pressure vessels exporting into China? A6:The overall procedure for obtaining the ML mainly consist of documents application and acceptance, type test (only refer to safety valves, bursting Discs, gas cylinders and accumulators), design approval (only refer to boilers, gas cylinders and accumulators), manufacture survey in site, audit report approval and license issue. In principle, type test and design approval shall be completed prior to the manufacture survey.
Q7: What kinds of documents should be submitted to SELO for Manufacture Licensing Application? A7: Application Form, Quality Manual, copy of company’s Business License, company introduction, demo/in-process product data (including drawing), copy of the certificates issued by other related international organ.
Q8: When the license will be issued after the on-site audit? A8: If there’s no rectification for the applicant to finish after the audit, the license will be issued within 25 working days after the audit team arrives in China.
Q9: What are the audit conclusions after the on-site audit? A9: comply with the requirements; comply with the requirements after rectification; not comply with the requirements.
Q10: How many auditors will be put in one audit team? A10: Generally, the audit team consists three persons. Two auditors are from CSEI and the third one is from governmental safety supervision organ.
Q11: How many working days are needed for the on-site audit? A11: The audit will not exceed 4 working days, it depends on different product category and level.
Q12: What’s the common on-site audit agenda? A12: (1) Initial meeting: The initial meeting is a meeting where both the appraisal and assessment team and the representatives from the manufacturer’s management, quality control department, and other related departments attend. The appraisal and assessment team will describe the main contents, methods, procedures and requirements of the on-site appraisal and assessment, and will confirm the applied category, type and level of the product with the applicant. (2) Plant tour: The plant tour will normally be arranged after the initial meeting. The appraisal and assessment team will make a quick tour of the related departments, workshops and laboratories under the guidance of the relevant personnel of the manufacturer so as to have an initial understanding of the manufacture’s situation, production conditions, product structures, manufacturing process, inspection conditions, etc. (3) Assessment of the manufacturer resources: The assessment team will review the lists of production facilities and human resources provided by the manufacturer and verify the manufacturer’s resources on the site. (4) Quality control document assessment: The means of document review generally include checking of documents, questioning key points and explanations by the manufacturer. (5) Assessment of quality control system implementation:The appraisal and assessment team will sample the product files and quality control records to assess the implementation of the quality management system. (6) Inspection of product safety quality: The appraisal and assessment team will inspect the product on the production site to assess its conformity with the applicable codes and standards, and its conformity with the requirements of China manufacture licensing on product safety quality. (7) Findings: After the on-site inspection and assessment, the appraisal and assessment team shall hold an internal meeting to sum up the assessment results. Then the appraisal and assessment team shall confirm findings with the quality management personnel of the applicant. The two parties shall enter into a memo (not applicable where there is no findings) regarding corrective measures and the time limit for rectification, which shall be confirmed and signed jointly by the leader of the assessment team and the manufacturer’s authorized representative. (8) Exit meeting: The exit meeting is a meeting where the appraisal and assessment team and the manufacturer’s management representative, quality control personnel and other staff from relevant departments attend. The team leader will make a comprehensive introduction of the checks, reviews, assessments and inspections, and give an oral conclusion of the on-site appraisal and assessment.
Q13: How much is the advance payment for on-site appraisal and assessment? A13: The applicant shall remit advance payment to the account named in Article 4 within 15 days after receipt of the invoice for new application and renewal application (The amount shall be converted into USD or EURO as per the exchange rate of the invoice issuing date converted). For the detailed rates and payments standards, please directly contact CSEI for consultation.