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Practical Guide to Distribution in China



1 Nov 2005
8-3 Products Requiring Quality/Safety Licensing

In line with common international quality management standards, China implements a product quality certification system for enterprises setting standards and technical requirements for products. For product subject to safety certification, the compulsory certification requirements under the Standardisation Law of the PRC will apply. For products subject to conformity certification, the national or industry standards laid down in the Standardisation Law will apply.

8-3-1 3C Certification

Products which have an impact on the health and safety of people, animals and plants, environmental protection and public security are subject to a unified compulsory product certification system. The Regulations for the Administration of Compulsory Product Certification, the Measures for the Administration of Compulsory Product Certification Mark, the Catalogue of the First Batch of Products Subject to Compulsory Certification, and the Circular on Issues Relating to the Implementation of Compulsory Product Certification provide the legal basis for compulsory product certification. They contain unified stipulations on the applicable product ranges, use of the CCC mark and supervision and monitoring of the system, etc. Products listed in the compulsory product certification catalogue must be certified by designated certification bodies, granted the relevant certificate and affixed with the CCC mark before they can leave the factory and be imported, sold or used.

Products Subject to 3C Certification
The catalogue of products subject to compulsory certification contains a list of 132 products under 19 categories. They span across nine industries including electronic products and electrical appliances, telecommunications products, vehicles and motorcycles, safety glass, fire prevention products, security products, agricultural machinery, latex products and vehicle tyres.

Quality Standards
Products listed in the catalogue are subject to compulsory safety certification, and a unified CCC mark is used.

There are four types of CCC mark, with each having five specifications:

Table

Certification Bodies, Procedures and Fees
Standard items and fees are charged for compulsory certification of products. The latest fee schedule is drawn up based on fees charged for similar certifications overseas.

The China National Regulatory Commission for Certification and Accreditation under the State Council is responsible for compulsory product certification across the country. The Commission designates certification bodies to conduct the certification work, and nine certification bodies and 76 testing centres have been appointed to date.

While the business of different certification bodies may vary from one another, their certification processes are basically similar, including: (1) handling applications for certification; (2) model testing; (3) factory inspection; (4) sample testing; (5) assessing certification results and granting approval; and (6) post-certification monitoring.

Fees for Compulsory Product Certification

Item

Fee

Remarks

Application

Rmb600 per application

A translation fee is charged for materials not in Chinese. The fee will vary depending on individual certification body actual expenses, but will not exceed Rmb1,000

Product testing


 

Based on the certification standards and technical requirements for the product

Factory inspection

Rmb3,000 x man-day

Based on the number of man-days required (including transport fees)

Approval and registration

(including certificate)

Rmb800 per certification

The certificate cost is based on the actual cost of producing the certificate, but will not exceed Rmb10 per certificate

Supervision and checking

The fee charged by the certification body will not exceed 25% of the factory inspection fee; the fee charged by the testing centre will not exceed 25% of the product testing fee

In cases where fewer than three products are selected for sample testing by the testing centre, the supervision fees to be charged are: for testing performed on one product, the supervision fee will equal 100% of the testing fee; for testing on two products, the supervision fee will be 50% of the testing fee; for testing on three products, the supervision fee will be 33% of the testing fee

Annual fee

For an enterprise granted 20 certificates or below (including from different certification bodies), an annual fee of Rmb200 is charged per certificate; if the number of certificates is between 21 and 50, an annual fee of Rmb150 per certificate is charged; if the number of certificates is above 50, an annual fee of Rmb100 per certificate is charged


 

Certification mark fee

Fees to be charged on the direct use of the CCC mark as required are:

8 mm mark - Rmb0.06 per piece

15 mm mark - Rmb0.12 per piece

30 mm mark - Rmb0.20 per piece

45 mm mark - Rmb0.30 per piece

60 mm mark - Rmb0.40 per piece


 

For marks allowed by certification bodies to be printed or pressed onto the product or its packaging, the fees to be charged are: Rmb900 for each usage for the first year, and Rmb600 from the second year onwards


 


3C Certification Bodies

Name

Service Scope

Contact Address

China Quality Certification Centre

CNCA-01C-001:
Electric wire components

CNCA-01C-002:
Electric wires and cables

CNCA-01C-003:
Plugs and sockets for household and similar purposes

CNCA-01C-004:
Switches for household and similar fixed electrical installations

CNCA-01C-005:
Plugs, sockets and couplers for industrial purpose

CNCA-01C-006:
Appliance couplers for household and similar purposes

CNCA-01C-007:
Thermal-links

CNCA-01C-008: Enclosures for accessories for household and similar fixed electrical installations

CNCA-01C-009:
Cartridge fuse-links of miniature fuses

No.15 Fang Cao Di Xi Jie, Chaoyang District, Beijing, China
100020

Telephone:
010-85622233

www.cqc.com.cn

China Quality Certification Centre (cont'd)

CNCA-01C-010:
Low-voltage switchgear assembly

CNCA-01C-011:
Switch and control equipment

CNCA-01C-012:
Installation protective equipment

CNCA-01C-013:
Small-power motor

CNCA-01C-014:
Electric tools

CNCA-01C-015:
Electric welding machines

CNCA-01C-016:
Household and similar purpose appliances

CNCA-01C-017:
Audio and video
equipment

CNCA-01C-018:
Equipment and components for cable distribution system of sound and television signals

 

China Quality Certification Centre (cont'd)

CNCA-01C-019:
Satellite television receivers

CNCA-01C-020: Information technology equipment

CNCA-01C-021:
Finance and trade settlement electronic equipment

CNCA-01C-022:
Lighting equipment

CNCA-02C-023:
Motor vehicle products

CNCA-02C-024: Motorcycle products

CNCA-02C-025: Motorcycle engine products

CNCA-02C-026:
Safety belts of motor vehicle

CNCA-03C-027:
Tyre products

CNCA-04C-028:
Safety glass products

 

China Quality Certification Centre (cont'd)

CNCA-07C-031: Telecommunications terminal equipment

CNCA-08C-032: Electrocardiographs

CNCA-08C-033: Haemodialysis equipment

CNCA-08C-034: Extracorporeal blood circuit for blood purification equipment

CNCA-08C-035:
Hollow fibre dialyzer

CNCA-08C-036: Implantable cardiac pacemakers

CNCA-08C-037:
Medical X-ray diagnostic equipment

CNCA-08C-038:
Artificial heart-lung machine roller pump

CNCA-08C-039:
Artificial heart-lung machine pulsatile roller pump

 

China Quality Certification Centre (cont'd)

CNCA-08C-040:
Artificial heart-lung machine bubble oxygenator

CNCA-08C-041:
Artificial heart-lung machine heat exchanger

CNCA-08C-042:
Artificial heart-lung machine water heating /cooling system

CNCA-08C-043:
Artificial heart-lung machine silicon rubber pump tube

CNCA-10C-047:
Detectors for intruder alarm systems

 

China Certification Centre for Electromagnetic Compatibility

CNCA-01C-001:
Electric wire components

CNCA-01C-002:
Electric wires and cables

CNCA-01C-003:
Plugs and sockets for household and similar purposes

No.18 Bei San Huan Dong Lu, Beijing, China
100013

Telephone:
010-64214583
010-64222575

www.cemc.org.cn

China Certification Centre for Electromagnetic Compatibility (cont'd)

CNCA-01C-004 :
Switches for household and similar fixed- electrical installations

CNCA-01C-005:
Plugs, sockets and couplers for industrial purpose

CNCA-01C-006:
Appliance couplers for household and similar purposes

CNCA-01C-007:
Thermal-links

CNCA-01C-008:
Enclosures for accessories for household and similar fixed electrical installations

CNCA-01C-009:
Cartridge fuse-links of miniature fuses

CNCA-01C-013:
Small-power motor

CNCA-01C-014:
Electric tools

 

China Certification Centre for Electromagnetic Compatibility (cont'd)

CNCA-01C-016:
Household and similar purpose appliances

CNCA-01C-017:
Audio and video equipment

CNCA-01C-018:
Equipment and components for cable distribution system of sound and television signals

CNCA-01C-019:
S
atellite television receivers (EMC)

CNCA-01C-020:
Information technology equipment

CNCA-01C-021:
Finance and trade settlement electronic equipment (EMC)

CNCA-01C-022:
Lighting equipment

CNCA-01C-031:
Telecommunications terminal equipment

 

China Certification Centre for Security and Protection

CNCA-10C-047:
Detectors for intruder alarm systems

10/F, Tian Lian Building, No.102, Lian Hua Chi East Road, Xuanwu District, Beijing, China
100055

Telephone:
010-63345560
010-51651890
--811

www.csp.gov.cn

Beijing CAM Quality Certification Centre

(previously China Certification Centre for Agricultural Machinery)

CNCA-05C-029 : Knapsack-style liquid and powder sprayer for crop protection

Nan Lu Shi Li He,
Dong San Huan, Chaoyang District, Beijing, China

100021

 

Telephone:

010-67347471

Beijing Zhonghua Combination Quality Certification Co Ltd

(previously China Committee for Conformity Certification for Tyres and China Committee for Conformity Certification of Latex Products)

CNCA-03C-027 :
Tyres products

CNCA-06C-030 :
Rubber condom

Room 410, Block 16, Zone 4, An Hui Li,
Chaoyang District,
Beijing, China
100723

Telephone:
010-84885047
010- 84885335

Fax:
010-84885414

www.cciq.net

China Safety Global Certification Centre

(previously China Safety Glass Certification Centre)

CNCA-04C-028 :
Safety glass products

Guanzhuang Dong Li, Chaoyang District, Beijing, China

100024

Telephone:
010-65775948
010-51167389

Fax:
010-65761715
010-65711591

www.csgc.org.cn

China Certification Centre for Fire Products of Ministry of Public Security

CNCA-09C-044 :
Fire alarm products

CNCA-09C-045 :
Fire hose products

CNCA-09C-046 : Automatic sprinkler system products

Jia 108, Xi Ge Xin Li, Yong Wai, Chongwen District,
Beijing, China
100077

Tel :
010-67274320

Fax:
010-87278660

www.cccf.com.cn

China Certification Centre for Automotive Products

CNCA-02C-023 :
Motor vehicle products

CNCA-02C-024 : Motorcycle products

CNCA-02C-025 : Motorcycle engine

CNCA-02C-026 :
Safety belts

4/F Shangzuo Building, Block B, 97 Xuanwumen West Street,
Beijing, China
100031

Telephone:
010-66418592

Fax:
010-66412672

www.cccap.org.cn


8-3-2 Certification for the Drug Industry

For drug production enterprises, GMP certification is compulsory, while GSP certification is required for drug distribution enterprises. In 2005, the State Food and Drug Administration further adopted the GLP standards, and the first batch of products subject to GLP certification includes new drugs, traditional Chinese medicine injections and biological products. Through adopting GLP→GMP→GSP, a drug quality and safety chain embracing laboratory tests, manufacturing and sale has taken shape in the mainland.