|
||
China
SAFETY & EMC COMPULSORY PRODUCT CERTIFICATION SYSTEM (CPCS)
Compulsory Product Certification System (CPCS) prohibits the sale or importation of equipment under the scope of the law that does not bear the CCC Mark issued by a Designated Certification Body (DCB). Products must comply with the compulsory standards before the CCC Mark is applied. The CCC Mark covers both safety and electromagnetic compatibility. The Mark will be noted by a letter reference indicating the type of certification. The CPCS regulates 25 different product groups, which include the following:
Compliance with Chinese national standards is required for the above product groups. Most Chinese standards (GB Nomenclature) are based on international standards with Chinese national differences. THE MEASURES FOR ADMINISTRATION OF INTERCONNECTION OF PUBLIC TELECOMMUNICATIONS NETWORKS
Additionally, nine categories of Telecommunications Terminal Equipment are regulated by the Compulsory Product Certification System (CPCS). The CPCS prohibits the sale or importation of equipment under the scope of the law that does not bear the CCC Mark. Products that fall under the scope of the law may be placed on the Chinese market after verifying full compliance with all the provisions of the law and then by applying the CCC Mark, which is issued by a CNCA Designated Certification Body (DCB). Following are the nine categories of Telecommunication Terminal Equipment that fall under the scope of the CPCS:
The following three types of telecommunications equipment cannot be connected to the public network or be sold in China with out a NAL/NAI.
Telecommunications terminal equipment is defined as telecommunication equipment providing subscribers with the capability to transmit and receive information that is connected to the terminal end of a public telecom network. Wireless communications equipment is defined as telecom equipment connected to a public telecom network that uses wireless transmission. Network interconnection equipment is defined as telecom equipment that permits interconnection and mutual communication between the networks of different telecom carriers or telecom service networks. The Measures are applicable to terminal equipment such as fixed and cordless telephone terminals, facsimiles, modems, pagers and multimedia terminals. Wireless communication equipment includes microwave communication equipment, satellite earth stations and wireless and paging base stations. Compliance with Chinese National Standards (GB nomenclature) is mandatory. The Chinese National Standards are based on International Standards (IEC and CISPR) with Chinese differences. The Chinese Telecommunications standards are typically based on the International Telecommunications Union (ITU) Telecommunications Standardization Sector. THE PROVISIONS OF THE RADIO REGULATIONS OF THE PEOPLE'S REPUBLIC OF CHINAAll radio-transmitting devices imported for sale and use in China must obtain a Radio Type Approval (RTA) certificate from the China State Radio Regulation Committee (SRRC) and be marked with the issued approval code (CMII ID). The RTA Certification regulates the following twenty-nine categories of radio-transmitting devices.
Under this provision, radio-transmitting device is defined as devices which transmit radio waves for use in radio communication, navigation, location, orientation, radar, remote control, telemetry, remote measurements, broadcasting, television, etc. The provision does not include devices that emit electromagnetic energy used in the industrial, scientific, and medical fields (ISM), electric transport systems, high-voltage power lines, and other electrical appliances. Radio-transmitting devices that require SRRC Type Approval must comply with China's national standards (GB), industry standards (YD), international standards (ITU or IEC), regional standards (ETSI or FCC), or regulations of the SRRC. THE REGULATION ON THE SUPERVISION AND ADMINISTRATION OF MEDICAL DEVICESThe Regulation on the Supervision and Administration of Medical Devices governs the research and development, production, distribution, use, supervision and administration of all medical devices within the territory of the People's Republic of China. All medical devices sold and used in China must, at a minimum, be registered with the State Food and Drug Administration (SFDA). In addition, products that fall under the scope of this Regulation may be placed on the Chinese market after verifying full compliance with all the provisions in the Regulation and have obtained a certificate from the SFDA. Additionally, seven categories of medical devices are regulated by the Compulsory Product Certification System (CPCS). The CPCS prohibits the sale or importation of equipment under the scope of the law that does not bear the CCC Mark. Products that fall under the scope of the law may be placed on the Chinese market after verifying full compliance with all the provisions of the law and then by applying the CCC Mark, which is issued by a CNCA Designated Certification Body (DCB). Medical devices, as defined by these regulations, refers to: those instruments, equipment, tools, materials and other objects, including the software attached to them, that are designed to be used either independently or in combination on the human body. It does not achieve its principal action in or on the human body by means of pharmacology, immunology or metabolism, but which may be assisted in its function by such means; the use of which is to achieve the following intended objectives:
Medical devices are classified in the following manner:
Following are the seven categories of medical devices that fall under the scope of the CPCS:
Products covered under the scope of this regulation will be required to comply with Chinese National Standards (GB nomenclature). The Chinese National Standards are based on International Standards with Chinese differences. The Implementation Rules for each category covered by the CPCS provides the Chinese National Standards that are applicable for a given product. CQC VOLUNTARY PRODUCT CERTIFICATION SYSTEMCQC Mark China Quality Certification Center (CQC), the National Certification Body under the IECEE CB Scheme and the largest CCC Certification Organization in China, has developed the CQC Voluntary Product Certification system. The CQC Voluntary Product Certification system, also known as the CQC Mark Certificate, covers hundreds of products divided into 51 categories. Product categories not covered under the China Compulsory Certification (CCC Certification) may fall under the CQC Mark Certificate scheme. Products that apply the CQC Mark have the following advantages:
CQC Mark The CQC Voluntary Product Certification System regulates 51 different product groups, some examples are:
Compliance with Chinese national standards is required for the above product groups. Most Chinese standards (GB Nomenclature) are based on international standards with Chinese national differences. CHINA ROHS The Management Methods on the Prevention and Control of Pollution Caused by Electronic Information Products (China RoHS) have been instituted to protect human health and the ecological environment and to enhance environmental management of substances on the first import to China. The Methods are regulated by the Ministry of Information Industry (MII) and apply to companies who wish to import or export chemicals within the territories of the People's Republic of China. China RoHS appears that it will be implemented in two phases, as follows: Phase one will apply to Electronic Information Product (EIP) manufacturers. EIP manufacturers, as of July 1, 2003, must take measures to reduce the use of toxic and harmful substances in production. The Electronic information products listed in the catalogue of products subject to special monitoring may not contain lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyl (PBB), polybrominated diphenyl ether (PBDE) and other toxic and hazardous substances or elements after March 1, 2007. During the self-declaration phase of China RoHS, manufacturers of Electronic information products as of March 1, 2007 must apply the China RoHS Marking (see below). Phase two will be implemented once the official catalogue has been published and designated certification/testing organizations have been established. This is expected to happen by end of year 2007. At this time, an official mark indicating the level of recylability has not been agreed upon. It has been discussed that the products must indicate the level of recyclability via a CCC mark. There are three types of recyclability marks: marks indicating that the product is fully recyclable, partially recyclable and non-recyclable. The samples and methods of such marking will be uniformly specified and issued for enforcement by the MII or by the MII in conjunction with other relevant state agencies. The design of these marks is yet to be determined. This regulation is similar to the European Union's Restriction of Hazardous Substances (RoHS) Directive. China RoHS Marking (self-declaration route)
number within circle - number of years designated as 'environmentally friendly use period OR
e within circle - product contains no hazardous substances The China RoHS applies to Electronic Information Products (EIP). EIP products covered by China RoHS will be published in the Key Catalogue. As of this writing, the Key Catalogue had not been established. The following 10 types of products have been defined as EIP. In addition, the Note for Classification of Electronic Information Products was issued by MII to further classify products that fall under the China RoHS.
Substances to be eliminated:
For products in which the above toxic and harmful substances cannot be completely replaced, the contents of such toxic and harmful substances shall not exceed the levels provided in relevant industrial or national standards for prevention and control of pollution caused by electronic information products. Exemptions:
UL SERVICES China participates in the IECEE CB Scheme for a variety of products. A CB report and certificate, including any national differences, issued from UL would act as a conduit into this marketplace with regard to the safety specifications. For more information visit our CB Scheme Web site. UL can assist manufacturers in expediting the Chinese Certification process through UL-CCIC, UL's joint venture in China. Customers work locally with their Market Access Solutions representative and your local representative coordinates the project with UL-CCIC. UL-CCIC assists in the facilitation of the submittals by working directly with the certification organization, test labs, and customs until the completion of the project. Learn more about our Intermediate Applicant Service. FOR FURTHER INFORMATION Should you have questions about UL's Market Access Solutions in China, require additional information, or wish to pursue any of these services, please contact us. |
Home Contact Us Regulatory Research Compliance Seminars Strategy Development Conformity Assessment Intermediate Applicant Technical File Assistance Export Requirements Print this Page E-mail this Page |
|