Chang-Hong Whitney04.05.06
Product Labeling and Documentation: Get Them in Order or Stay at the Border
Chang-Hong Whitney |
China’s State Food and Drug Administration (SFDA), as the top government administrative authority for medical devices, has published numerous regulations aimed at managing and regulating the market; two areas of focus include product labeling and documentation.
As the agency that controls the Chinese borders and importation of foreign goods, China’s State General Administration of Quality Supervision and Inspection and Quarantine (AQSIQ) has also imposed general requirements regarding labeling for imported products. Therefore, international medical product suppliers need to understand and comply with both SFDA and AQSIQ regulations when selling their products in the Chinese market.
From an SFDA perspective, products made in foreign countries must first be registered with SFDA before they can be marketed to Chinese customers. Packaging for imported products must contain labeling information that includes the following items in Chinese language:
• Product name, model, type
• Manufacturer’s name, address, production location and contact information
• Production date or serial number
• Power requirements
• Expiration date, etc.
• SFDA product registration number
• SFDA product standard number
While most of these items are routine for international manufacturers, the SFDA registration number and associated product standard number are unique for China. These numbers are assigned to the manufacturer when the product is registered with SFDA and must be shown on product labels. A manufacturer should leave enough space on its label design for these two items.
The SFDA requires that foreign products must be accompanied with an IFU (Instruction for User or User’s Manual) when sold to China. It must be written in Chinese and include the following information:
• Product name, model, specifications, features, application, warnings, maintenance and service requirements, etc.
• Manufacturer name, address, production location, contact information and service agent’s name, address and contact information
• SFDA product standard number
The AQSIQ, from the border control and import supervision perspective, requires that foreign products have the following information, in Chinese, on their outside package labels:
• Manufacturer’s name, address
• Product name, model, type
• Production date or serial number
• Power requirements
• Expiration date, if applicable
• Storage conditions
• CCC Certification number for products on CCC mandatory list
Note that the manufacturer’s name and address can be in the company’s native language, but the product name, power rating and other information must be translated into Chinese.
In 2002, AQSIQ implemented the regulations on compulsory product certification, called China Compulsory Certification (CCC), which is aimed at safeguarding consumer safety and ensuring product quality. Seven categories of medical products are on the CCC mandatory list. These products must pass the CCC certification process before they can be imported to China. The CCC number and logo must be shown on both the outside package label and product label. If the CCC logo is to be printed on the label by the manufacturer, a special label approval must be obtained from CCC agency.
Compliance Remains an Issue
Although the above regulations have been in effect for some time, implementation by foreign suppliers has been lacking. Many foreign products are sold to China without Chinese IFUs. Some manufacturers updated their own IFUs but failed to update their Chinese version and didn’t file the new copy with SFDA. Some products do not have proper warning labels or Chinese translations. Other products have technical improvements that may require separate registration. In response, both SFDA and AQSIQ have stepped up inspection and surveillance programs.
The SFDA randomly inspects products on the market. These inspections are administered by SFDA and conducted by local FDA agencies with support from SFDA technical testing centers.
Product categories are randomly selected by SFDA. Inspections are conducted through samples submitted by manufacturers; some are done at actual installations in hospitals. Product labeling and IFU are inspected against the filed product registration documents. Key technical specifications are tested by SFDA testing centers against China’s industry and product registration standards.
The SFDA issues quarterly quality inspection reports that list the companies that have passed or failed the inspections. In addition, SFDA also has drafted policies on adverse incident reporting and its re-certification process. The administration conducted a pilot program in 2004 to test run the program on Class III implantable products.
The AQSIQ enforces its requirements at the border. Package labels are the first visual inspection item performed by customs officers. Products on the CCC mandatory list, but without CCC certifications, are not allowed to enter the country. In addition, products without a proper CCC label or sticker are returned to the suppliers. Manufacturers are also subject to an annual quality audit by CCC officials. The CCC label also requires annual approval by CCC agencies.
A feature article, “China’s Regulatory Challenges,” published in the July/August 2005 issue of Medical Product Outsourcing, emphasized the importance of compliance activities after a foreign product is registered in China. The most recent developments certainly have validated the Chinese government’s intent to further strengthen its established policies and systems. It is advisable for international medical device companies to re-examine their products and documentation according to Chinese rules and regulations, to avoid future stoppage at the Chinese borders or penalties for non-compliance by Chinese agencies.
In addition to the established SFDA and AQSIQ rules, the Chinese Ministry of Information Industry will be putting another new regulation in effect on January 1, 2007. According to reports, the new Administrative Measures on the Control of Pollution Caused by Electronic Information Products (known as the China RoHS law) is likely to affect medical devices entering China in terms of product labeling, testing and importation. In coming months, this column will provide more details on this regulation as rules are formulated and published.