Approvals for China and Taiwan
Goods Imported to the Chinese and Taiwanese Markets
China is rapidly emerging as the world's leading economic power. Any product covered by the Chinese Catalogue should acquire the CCC Mark before it can be marketed, imported or used for any commercial purposes in China. TÜV Rheinland is here to help you avoid time-consuming and costly barriers on your way to entering the Chinese market. We can provide you with the information you need concerning import requirements for your products. Authorization is required in Taiwan for electrical, mechanical, and chemical products. We can conduct the necessary tests and obtain product approval from the Bureau of Standards, Metrology, and Inspection (BSMI).
Benefits at a Glance
With TÜV Rheinland product approval, you can:
- Gain quicker market access
- Competitively position your products with our independent third party approval
- Benefit from our years of experience and expertise
Our Services for Approval for China and Taiwan
- Regulatory research and consultation
- Documentation requirements and management
- Coordination of in-country testing and local representation
- Preparation and submittal of country-specific application packages
- Comprehensive project tracking and monitoring
- Multi-country turn-key approvals
- Central knowledge database to meet all regulatory needs
- Compiling the technical files and submittal with the target market country regulators or certification bodies
- Project management with weekly updates on target market approval status from receipt of technical file, start of tests (if any), review certification and planned lead times
- Early updates on target market labeling, packaging requirements, required translations and regulatory statements
- Training, research and seminars
Depending on the product category, China requires various approval and registration processes. These procedures are carried out exclusively by state authorities. Foreign inspection agencies are permitted to perform some secondary tasks, such as production site inspection. We offer an invaluable service - thanks to our local presence and detailed knowledge of Chinese regulations. Our Chinese experts in Germany and China work closely with local laboratories and certification authorities - providing you with the accurate information you need.
CCC Certificates for Electrotechnology
The most widely-recognized authorization process is China Compulsory Certification, or CCC. It applies primarily to electrotechnology and motor vehicles. Products missing the required CCC certificates will be turned away at the border.
Medical Products: CCC and Additional Registration
The CCC requirement also applies to various medical devices - including x-ray machines, electrocardiographs, and pacemakers. All medical devices must be registered with the State Food and Drug Administration (SFDA). We would be happy to assist you in both procedures. For more information, please consult our Web pages on medical products and technology.
Boiler, Pressure Vessels, and Safety Equipment: SELO Approval
Boilers, pressure vessels, and safety equipment are subject to "Manufacture Licensing of Special Equipment" guidelines. These place special emphasis on the manufacturer's qualifications and compliance with industry standards. The manufacturer must therefore create a special quality management handbook, along with a product sample, as part of an audit. This has come to be known as "SELO approval," given the Special Equipment Licensing Office associated with the procedure.
Hazardous Substances in Electrical and Electronic Products
Since March 2007, labels have been required on electrical and electronic products containing hazardous substances. This regulation is comparable to the European RoHS Directive 2002/95/EC. There are some differences in the scope and implementation of the guidelines - however, the six regulated hazardous substances are the same.
Telecommunications and Radio
The State Radio Regulation Center (SRRC) requires state laboratory testing and approval for radio equipment. Telecommunications devices that fall into one of 28 product categories require a Network Access License (NAL). These devices must also be tested before receiving approval.
Import License for Used Machinery
There is no general authorization procedure for machinery entering China, with the exception of certain spare parts and welding machines. An import license is, however, required for used foreign machinery. This is issued by the Chinese authority AQSIQ. We will prepare a report for the machine in question - or simply handle the entire process, including the work with AQSIQ.
The China National Institute of Standardization (CNIS) issues labels for energy efficiency in various products - and the list grows ever longer. It already includes refrigerators, air conditioners, lights, and three-phase motors. If your product meets the Chinese standards, it may receive the Energy Efficiency label. We will help you test and register your product.
Authorization Requirement for Electrical, Mechanical, and Chemical Products
Electrical, mechanical, and chemical products in Taiwan must be authorized. Four different methods are employed for authorization, depending on the scope of the delivery and the product safety levels.
The Most Common Methods
Individual deliveries are typically subject to a Type Approved Batch Inspection (TABI) at customs. A fee is required. Registration of Product Certification (RPC) is recommended for repeat deliveries. A modular system is employed to evaluate the conformity of your products. Safety and electromagnetic compatibility tests are required in both procedures described. We will conduct the necessary tests and obtain product approval from the Bureau of Standards, Metrology, and Inspection (BSMI). The only persons who may receive this approval are either the importer or a local representative of the foreign manufacturer.
BSMI Certification for Medical Devices
Medical devices are also subject to authorization in Taiwan. A GMP compliance letter is required in the application for product approval - we are happy to provide you with one, as part of your audit. This is based on the Technical Cooperation Program (TCP). For more information, please consult our Web pages on medical products and technology.
- International Approvals (PDF, 751 KB)