holz

Regulatory Requirements for China: 

Regulatory Requirements for China Bill Holz Intertek Global Market Access

Background on China Certifications: 

Background on China Certifications Prior to the new China Compulsory Certification System (CCC), China’s Regulatory Scheme was made up of the following certification marks: CCIB Mark for non-Chinese companies CCEE “Great Wall” Mark for Chinese companies

The New Compulsory Product Certification System (CPCS): 

The New Compulsory Product Certification System (CPCS) World Trade Organization (WTO) Commitment Boost National Economy in China “One Stop Shopping” Free Access to International markets

The New Compulsory Product Certification System (CPCS): 

The New Compulsory Product Certification System (CPCS) After August 1, 2003, the CCC mark officially replaced CCIB and CCEE, and become the mandatory mark in China What does CCC stand for? China Compulsory Certification

The New Compulsory Product Certification System (CPCS): 

The New Compulsory Product Certification System (CPCS) Organizational Structure State Council CNCA – Certification and Accreditation Admin for the People’s RoC AQSIQ – State General Admin of the People’s RoC for Quality Supervision, Insp and Quarantine SAC - Standardization Admin of China Compulsory Certification & Lab Accreditation Marketplace Surveillance Border Control (Insp & Quarantine) Standards Setting

Responsibilities: 

Responsibilities CNCA Is authorized by the State Council to establish, guide, implement and supervise the Compulsory Product Certification System – CPCS Is required to keep the certified products commercially and technically confidential. Illegal use of the scientific and technical achievements are prohibited Is not allowed to provide consulting services and/or participate in the development of products being certified AQSIQ Determines the rules and regulations for CCC Reviews and approves Catalog Items in cooperation with CNCA Local branches are responsible for surveillance over the products listed in the catalog SAC Develops National Standards – Designated GB

Designated Certification Bodies -- DCBs: 

Designated Certification Bodies -- DCBs There are nine (9) organizations designated by CNCA to implement and conduct compulsory product certifications (CCC). Carry out the certification activities for specific products Issue certificate to applicants

Designated Certification Bodies -- DCBs: 

Designated Certification Bodies -- DCBs The Largest DCB is the China Quality Certification Center (CQC) China Quality Certificate Center (CQC) was originally established by SAIQ for fair treatment of foreign manufacturers. Most products entering China have to pass through CQC.

Products That Require CCC: 

Products That Require CCC The first group of products to be certified by the new system covers 132 products and 19 Categories. Electrical Wires and cables – 5 items Switches for Circuit, installation protective and connection device - 6 items Low-Voltage Electrical Apparatus – 9 items Small power motor – 1 item Electric tools – 16 items Welding Machines – 15 items Household and similar electrical appliances – 18 items Audio and Video apparatus – 16 items

Products That Require CCC: 

Products That Require CCC Information Technology Equipment – 12 items Lighting Apparatus – 2 items Telecommunication Terminal Equipment – 9 items Motor Vehicle and Safety Parts – 4 items Motor Vehicle Tires – 3 items Safety Class – 3 items Agricultural Machinery – 1 item Latex Product – 1 item Medical Devices – 7 items Fire Fighting Equipment – 3 items Detectors for Intruder System – 1 item

Catalog: 

Catalog New edition is under development Expect other equipment to be added to the catalog – keep checking Harmonized Tariff Code should be checked to ensure CCC is not required – equipment names is not the best guideline to determine if your equipment needs certifications or not

Exemption of Compulsory Certificate: 

Exemption of Compulsory Certificate Products Used for Science research/test Components to evaluate techniques Foreign trade contract Components implemented in a product to be exported abroad Trade show sample (not for sale)

CCC Component Requirements: 

CCC Component Requirements Components which are imported for sale must be certified if listed in the catalog Components which are installed within the integral assemblies when released from the factory or imported may not be required to be certified (even if the component is in the catalog) If an assembly/product is not listed in the catalog, but the components used are listed, the product may not be required to be certified May impact philosophy on how companies spare products

CCC Certification Process: 

CCC Certification Process Application for Certification The application must be completed in simplified Chinese If an agent is used, they must be licensed Type Testing In-country testing is required There are over 70 labs in China (Client does not select lab)

CCC Certification Process: 

CCC Certification Process Initial Inspection of Factory The inspection includes factory quality assurance, ability assessment and product consistency check The inspector assigned by DCB will carry out this Assessment Evaluation of all Results Test report and audit review Follow-up Inspection Inspections are once a year after initial audit

CCC – General Information: 

CCC – General Information Term of license: 1 Year Annual renewal fee: RMB 1,000 Label requirements: Printed, Pressed, Molded, Screen-Printed, Painted etc. Time to gain certification – time can be from 2 – 12 months if going it alone (does not include audit)

China – Legal Requirements: 

China – Legal Requirements Residence requirements – Must be legally established for certain certifications such as MII for telecom. Not required for just CCC Language requirements – Simplified Chinese

Other Certification Requirements in China: 

Other Certification Requirements in China Telecom – MII (NAL) Radio (RF) - SRRC TV Connection – SARFT Medical – SDA Scientific Equipment – CPA Devices with Encryption - MPS

Other Certifications: 

Other Certifications Equipment that connects in any way to the TV network will require SARFT Includes cable modems, satellite TV equipment, etc. Equipment used for scientific purposes will now require certification by the CPA a new organization. Previously this was the SBTS. They currently are issuing warrants requiring products to be tested and certified

Other Certifications: 

Other Certifications Equipment using encryption will require MPS certification The encryption part of the product must be provided by a company in China Testing will be required Others – Could be out there that we have yet to discover

Multiple Certifications: 

Multiple Certifications Many of the products categorized as telecom, medical, radio, etc. and listed in the CCC catalog will also require additional agency certifications In turn many of the products not listed in the catalog in these same categories will require other agency certifications In numerous cases products can require as many as 3 or more certifications (wireless device used for medical applications)

Additional Testing and Audit Requirements: 

Additional Testing and Audit Requirements China is a CB member, but will generally require a sample EMC testing is normally required to be conducted in country (special arrangements can be made) Product specific testing (telecom, RF, medical, etc.) also is generally done in country, but once again, special arrangements can be made to have the testing done locally

Summary: 

Summary Placing products on global markets requires that companies comply with many national laws Early identification and planning is essential Certifications in China can be many and complex depending on the equipment Certifications for China are expensive - $10K for a simple product is not unusual. $40K for a complex product is common Mistakes and failures can cost an additional 6 months in certification time