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Q1: What type of special equipment exporting into China are subject to China Manufacture Licensing system (ML)?
A1: Boilers, pressure vessels (including gas cylinders), bursting discs, safety valves, valves of gas cylinders,and emergency stop valves.

Q2: What are the main responsibilities of SESA, SELO and CSEI respectively in the field of special equipment manufacture licensing system?
A2: Special Equipment Safety Administration Bureau (SESA), AQSIQ is the governmental authority in charge of special equipment manufacture licensing. Its main responsibilities are legislation and policy formulation. Special Equipment Licensing Office (SELO), AQSIQ is an office established by SESA. SELO handles daily contact between applicants and Chinese authorities. Its main responsibilities include policy consultation,receiving and processing application materials. China Special Equipment Inspection and Research Institute (CSEI) is a state-owned inspection agency for special equipment. Its main responsibilities include domestic and international manufacturer audits, and special equipment inspections.

Q3: What does the assessment (audit) focus on?
A3: 1). Confirm the condition of production site, manufacturing and processing facilities, inspection and testing equipment and working personnel;
2). Review the quality manual and relevant quality management system supporting documents;
3). Check the implementation of the quality management system;
4). Review the relevant technical documents of demo product(s);
5). Inspect and test the demo products.

Q4: What are the conclusions for the on-site audit?
A4: The audit conclusion shall be classified as “accord with the requirements”, “need to rectify” and “disaccord with the requirements”.

Q5: How to access the codes and regulations related to manufacture licensing?
A5: The relevant safety technical codes and regulations can be downloaded from CSEI’s website http://www.cbpvi.org/eng_index_detailList.jsp?navName=safetyCodesAndStandards&pageNo=1&menu=10

Q6: What are the main procedures for obtaining China Manufacture License?
A6:a. New Applicant for Boiler & Pressure Vessel Manufacture License
1) The applicant shall apply to SELO for manufacture license.
2) The applicant, whose application has been accepted, shall manufacture demo product for on-site audit.
3) CSEI dispatches audit team to carry out the on-site audit.
4) License issue by SESA of AQSIQ

b. Renewal Applicant for Boiler & Pressure Vessel Manufacture License
1) The applicant shall apply to SELO for manufacture license renewal at least 6 months prior to the expiry date of the license.
2) CSEI dispatches audit team to carry out the on-site audit.
3) License issue by SESA of AQSIQ

c. Applicant for Accumulator, Gas Cylinder, Rupture Disc, Safety Valve, Gas Cylinder Valves and Emergency Stop Valve Manufacture License
d. Applicant for Boiler, Gas Cylinder Manufacture License
1) The applicant shall apply to SELO for manufacture license.
2) The applicant, whose application has been accepted, shall complete type tests before the on-site audit (applicable for products in item c). The applicant, whose application has been accepted, shall complete design document appraisal before the on-site audit (applicable for products in item d).
3) CSEI dispatches audit team to carry out the on-site audit.
4) License issue by SESA of AQSIQ

Q7: What documents shall be submitted to SELO for Manufacture Licensing application?
A7: Both new and renewal applicants shall submit all application material to SELO via Special Equipment Administrative Licensing Application System of AQSIQ (http://sepsclient.cnse.gov.cn/Home). The main application material includes Application Form, copy of Applicant’s Business License, Quality Manual (Contents of quality manual as minimum), and copy of Chinese Manufacture License (only applicable for renewal applicants).

Q8: What are the steps for audit report review after the on-site audit?
A8: After the on-site audit and returning to China, the audit team shall submit the audit report according to CSEI rules for internal review. After the internal review, the audit report will be transferred to SESA of AQSIQ for approval. SESA shall decide whether the license shall be issued or not within 25 working days after receiving the audit report.

Q9: How many auditors in one audit team?
A9: Generally, the audit team consists of three people, two people from CSEI and another people from governmental safety supervision organ.

Q10: How many working days are needed for the on-site audit?
A10: Normally 3 to 5 working days are needed for an on-site audit depending on the application scopes and the size of the manufacturers.

Q11: What’s the normal on-site audit agenda?
A11:
(1) Opening meeting
(2) Quick shop tour
(3) Demo products sampling by audit team (only for new applicant)
(4) Confirmation of the manufacturer’s resource
(5) Quality system documentation review & assessment
(6) Technical file review of demo products
(7) On-site inspection of demo products (only for new applicant)
(8) Verification of quality system implementation
(9) Production field check
(10)Audit records sum-up
(11) Internal meeting of Audit team
(12) Audit memorandum drafting (if necessary)
(13) Final meeting

Q12: How to pay for the on-site audit?
A12:
The applicant shall remit advance payment to CSEI account within 15 days after receipt of the invoice.After the completion of the on-site audit, CSEI will send a final payment notice (second invoice) and detailed statement of payment to the applicant. The applicant shall settle all due payment following the same requirements as above. The rates and payment of manufacture licensing formulated by CSEI will be provided to applicants for reference upon request.


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