China

The Chinese authority CNCA issued an announcement regarding the China Compulsory Certification Implementation Rules, which accredited five more certification organizations. The much criticized CQC-monopoly especially regarding electric devices now belongs to the past. The new organizations will primarily deal with the following product-groups:CTC (Guangdong Quality Testing CTC Certification Co. LTD): Cables, switches, electric lighting, low-voltage electrical componentsCQM (China Certification Center for Quality Mark): switches, electric hand tools, welding machines, other electric componentsCESI (China Electronic Standardization Institute): Audio/video equipmentCVC (Guangzhou VKAN Certification and Testing Co. Ltd.): Circuit breaker, assembly locking, connections for electric installations (and accessories), electric motors and household appliancesCGC (China General Certification Center): Household appliances.For further information please contact:Cisema China Certification GmbHTel.: +49 89 4161 7389 – 00Fax: +49 89 7484 9956info@cisema.dewww.cisema.com

AQSIQ is planning to introduce an official certificate of clearance for all food imports.On 1.10.2017 announcement 83 2017 issued by AQSIQ (Administration for Quality, Safety, Inspection and Quarantine of China) will come into force. From then on, all food exported to China must be accompanied by an official certificate of clearance, which is to be issued by the competent authorities in the country of origin. Up to now, AQSIQ has not communicated any details, like which authorities are accepted by AQSIQ or which information is to be contained in the certificate.Many of China's trade partners have already filed a note of protest at WTO against this regulation and the feasibility of the Chinese plans is most uncertain according to expert opinions.We shall inform you immediately, if there are any news on the certificate of clearance.For further information please contact:Cisema GmbHTel.: +49 89 4161 7389 00Fax: +49 89 7484 9956info@cisema.dewww.cisema.com

On August 21st 2014 the CNCA has publicized its announcement 31/2904 dealing with the revised implementation rules for CCC-certification of all automotive products, vehicles and their components.The most significant adjustments affect the product group “interior materials”: New products have been included in this group such as sound and thermal insulation materials used in the engine compartment. Also certain products that before were free of CCC will need certification under the new rule. This applies for instance to instrument panels, center consoles, floor mats and boot linings for sports cars and convertibles.Also there are new definitions regarding inspection and spare part management, some of which have already been in use by the Chinese certification organizations over the past years.All new regulations will be officially implemented on January 1, 2015.For more detailed information please contact us:Cisema China Certification GmbHTel.: +49 89 4161 7389-00Fax: +49 89 7484 9956info@cisema.dewww.cisema.de

Introducing QR code for the China Energy Label (CEL).Back in spring the Chinese authorities AQSIQ (General Administration of Quality Supervision, Inspection and Quarantine of P.R. China) and NDRC (National Development and Reform Commission) drafted a change of the energy efficiency labeling. The intention is to make it easier for Chinese consumers to check on the energy efficiency of a product using online media.See below example:[caption id="attachment_1345" align="alignnone" width="182"] credit: 24.08.2016: https://www.cnca.gov.cn/xxgk/ggxx/2016/201608/W020160803588217825962.pdf[/caption]With immediate effect the labels have to be adjusted and get approval from the China Energy Label Center (CELC). Starting October 1^st 2016 the import of products to China carrying the old efficiency label will be problematic.What has also changed is that web shops have to include the QR-code in their product description. Distributors have to do incoming goods inspections, to check on the CELC-registration and ensure that only conformal goods are traded.For more information please contact:Cisema China Certification GmbHTel.: +49 89 4161 7389 - 00Fax: +49 89 7484 9956info@cisema.dewww.cisema.com

In their announcement 23/2014 from July 2014, the Chinese certification authority CNCA has publicized the release and implementation of seventeen new “implementation rules” required for CCC certification.The new implementation rules apply to electric devices, such as cables and lines, switches and switching devices, low voltage motors, welding tools, domestic appliances, audio, video and IT-equipment, as well as non-electrical products such as safety glass, agricultural tools, theft alarm systems and decoration products.The new regulations will be officially implemented on September 1, 2014. Existing certificates are still valid, but the appropriate adjustments to the new rules should be done at the next available opportunity.For more detailed information please contact us:Cisema China Certification GmbHTel.: +49 89 4161 7389-00Fax: +49 89 7484 9956info@cisema.dewww.cisema.de

China RoHS 2.0 „Compliance Management Catalog“ progressing to next phase.On February 3rd 2016 the responsible authorities (published an update on the regulation for hazardous substances - RoHS 2.0. The regulation is effective since July 1^st 2016 (we reported).Originally a „Compliance Management Catalog“ was scheduled for publishing in October 2016. The content should provide a definition, whether a mandatory registration, and possibly an inspection of the manufacturer, will be introduced. So far there was no progress. On July 28^th 2017 a consultation of the authority MIIT with business representatives ended. We expect to receive further information about the future approaches for China RoHS by end of this year.For further information please contact:Cisema China Certification GmbHTel.: +49 89 4161 7389 00Fax: +49 89 7484 9956info@cisema.dewww.cisema.de

Recalls of Medical Device Regulation Updated .On September 2nd 2016 a new draft for handling recalls of medical devices has been released. The revision will replace the current regulation 82/2010 from the Chinese Ministry of Health dated 28.06.2010. It describes the key points leading to a recall.

1. If the medical device poses hazardous risks
2. If the medical device does not meet the regulation standards
3. If during manufacturing and/or distribution violations of the current medical device regulations occur
4. If any further adverse events ask for a recall

The draft also gives some guidelines for the management of recalls.

1. When the recall occurs outside of China the appropriate departments of the NMPA have to be informed
2. Within China:- Monitoring the safety of medical devices- Communication, reporting and close cooperation with the NMPA- Organization of the recall – assessment, if applicable relabelling, modification of the quality manual and/or software up-grades. Also of course repairs or replacement of the device and its disposal have to be taken care of.- Compensation- Penalties

When there is proof of the defectiveness of the device, and the NMPA-Legal-Agent fails to report to the NMPA, the NMPA may initiate the recall.Violation of the regulations can result in fines for the NMPA Legal Agent or even cost him his license.Recalls will be published in the NMPA database stating details of the product, its manufacturer and NMPA Legal Agent.For more information please contact us:Cisema GmbHTel.: +49 89 4161 7389 – 00Fax: +49 89 7484 9956info@cisema.dewww.cisema.com

NMPA – New Application Deadlines for Cosmetics. As of Sept.1^st, 2017 the deadlines for the application of certificate renewals or changes will be as follows:

• Renewal application must be submitted six months before expiry and not four months as before
• Certificate changes, completions or corrections must be applied for ten months before expiry now. Renewal and change applications can be submitted at the same time.
• The technical review by NMPA for a certificate renewal will take three months counting from the acceptance date of the application.

Further information on the above topic can be obtained from:Cisema GmbHTel.: +49 89 4161 7389 – 00Fax: +49 89 7484 9956info@cisema.dewww.cisema.com

New product catalog and new HS* codes for the CCC certification in PR ChinaIn two recent successive announcements by CNCA ** with the numbers 30 and 36 the scope of the CCC (China Compulsory Certification) certification is re-regulated. The new catalog of the top certification authority of CHina covers 22 product groups and 157 categories with current descriptions and definitions. In order to unify the implementation by the local customs offices better, additionally the list of affected HS codes (tariff codes) was brought up to date. Both lists are available in their original version only in Chinese.For more information about CCC certification in the VR China please get in touch with us.* = Harmonized System** = Certification and Accreditation Administration of China

The Chinese certification authority CNCA (Certification and Accreditation Administration) has updated the list of product categories subject to CCC certification (China Compulsory Certification). Quite a few products have for instance been added to category 11 the “Motor vehicles and safety-relevant accessories”. It now includes insulation material in the engine compartment, floor mats, dashboards and devices for indirect vision. Category 20 “children products” now also contains child-seats.The previous 22 categories were reduced by two: Latex products and medical devices have been switched to NMPA (China Food and Drug Administration).Currently the CCC certification requirements apply to the following product groups:

1. Electrical wires and cables
2. Circuit switches, electric devices for protection or connection
3. Low-voltage electrical apparatus
4. Low power motors
5. Electric tools
6. Welding machines
7. Household and similar electrical appliances
8. Audio and video apparatus
9. Information technology equipment
10. Lighting apparatus
11. Motor vehicles and safety-relevant accessories
12. Motor vehicle tires
13. Safety glasses
14. Agricultural machinery
15. Telecommunication terminal equipment
16. Firefighting equipment
17. Home safety protection products
18. Wireless network devices
19. Home decor and remodeling products
20. Children products

If you have any more questions please contact us at:Cisema China Certification GmbHTel.: +49 89 4161 7389 - 00Fax: +49 89 7484 9956info@cisema.dewww.cisema.com

CCC certification - dimensions of interior and insulation materials in the automotive sector further specified:On 01.01.2015 the new implementation guideline of the CNCA (Certification and Accreditation Administration of the People's Republic of China) for automotive interiors and insulating materials came into force (CNCA-C11-09:2014). With this regulation, a number of new components have been included in the scope of CCC certification (China Compulsory Certification). This led to an increase in the number of applications for CCC certification of products whose relevance was not clear.The competent Commission was therefore obliged to publish a further clarification of the Directive in December 2015. Based on last year's experience, especially with frame parts, components that completely cover a rectangle with the standard dimensions 356 x 100 mm are considered for certification. The final decision on compulsory certification clearly focuses on the geometry of the component. For example, a large component with several holes, one of which occupies more than 50% of the total area, may not be eligible for certification if the test sample cannot be cut in the required shape and size. In cases of doubt, the respective Chinese certification organisation makes an individual decision. Until now, smaller components were also accepted for certification if they reached the standard dimensions only in terms of length and width (e.g. in the form of a triangle). For affected components, certification can be maintained or cancelled if desired.Further information on the topics mentioned can be obtained from:Cisema China Certification GmbHTel.: +49 89 4161 7389-00Fax: +49 89 7484 9956info@cisema.dewww.cisema.de

NMPA Issues Charging Standards for Drug and Medical Device RegistrationOn May 27, the China Food and Drug Administration ("NMPA") released its “Charging Standards for Registration of Drugs and Medical Devices” which come into force immediately. For pharmaceuticals, foreign companies will have to pay for clinical trials or marketing approvals, medical device companies have to pay for class II and III registration. This applies to new and change applications as well as the extension after five years.For small to micro enterprises in China doing medical innovation, the NMPA has set up a preferential policy of waiving registration fees and supplementary application fees.For more information please contact us at:Cisema China Certification GmbHTel.: +49 89 4161 7389 - 00Fax: +49 89 7484 9956info@cisema.dewww.cisema.com

Online Trade - Deliveries Classified as Products for Personal Use.As of 1^st January 2018 the Chinese customs authorities will treat all commodities traded through CBEC as articles for personal use. The reason is that commodities traded through CBEC are for private persons and usually have a low value and low quantities.Another five pilot cities for CBEC will be nominated: Besides Hangzhou, Tianjin, Shanghai, Chongqing, Zhengzhou, Guangzhou, Ningbo,Shenzhen, Fuzhou und Pingtan, there will now be added Chengdu, Dalian, Qingdao, Suzhou und Hefei.More details for the supervision will be published shortly. It can be assumed, however, that certain product groups which normally need registration or certification, can be traded and imported freely through CBEC. Among these commodities are:Ordinary cosmetics such as lotion, cream, facial mask, shampoo

• Nutritional supplements such as vitamin and mineral preparations
• CCC products such as coffee machines, vacuum cleaner
• Freely traded medical devices such as electronic sphygmomanometer

It has not been decided yet if the new regulation also applies to infant formula.Further information on this topic can be obtained from:Cisema GmbHTel.: +49 89 4161 7389 – 00Fax: +49 89 7484 9956info@cisema.dewww.cisema.com

China Adjusts Its Import Control for Child Safety Seats and Alloy Wheels.With announcement 147/2014 the “General Administration of Quality Supervision, Inspection & Quarantine of China” (AQSIQ) and the “General Administration of Customs of China” (GACC) the entry/exit inspection-quarantine requirements have been imposed on car seats for children as well as automotive alloy wheels/parts.As of September 1^st 2015 child safety seats are also subject to the mandatory CCC-certification.For more information please contact us:Cisema China Certification GmbHTel.: +49 89 4161 7389 – 00Fax: +49 89 7484 9956info@cisema.de www.cisema.de

Energy efficiency labeling requirements for electric motors in the People's Republic ChinaThe two recent successive announcements with numbers 136 and 137 of the ELAC (Energy Label Administration of China) re-regulate the energy efficiency labeling of electric motors in the People's Republic China. In addition, the update of GB standard 18613-2006 with number GB 18613-2012 was implemented without transition. Currently, the old label is accepted still, but for the next annual report to the ELAC, the current standard must be specified. For this reason, the type of tests must be carried out according to GB 18613-2012 as soon as possible.Currently, the energy efficiency labeling is valid for electric drives for 3-phase asynchronous motors. In the future, synchronous motors with permanent magnets and 3-phase induction motors will be affected also.More information on energy efficiency labeling in the VR China can be obtained from us. Please let us know if you need anything.

China Food and Drug Administration (NMPA) report on registration of medical devices in China.NMPA recently published its Annual Report 2016 on medical device registration. The number of registrations in Class II, III and IVD has increased to 8.653, which is a plus of 14.9 % compared to the previous year. The retracement suffered in 2015 was due to the various regulatory changes dating back to 2014 as well as the increase of application fees in 2015, but the current figures have reached the 2014 level again.A large percentage of applications for the registration of medical devices and IVD comes from abroad. Class II had 3.095 applications from abroad, which is an increase of 2% compared to 2015 and in Class III there were 2.818 applications, an increase of even 15%.The P.R. China continues to promote the import of high-end and high-cost medical devices from abroad. The top five class II and III product groups of foreign origin to be registered in 2016 were:

1. Implanted material and artificial organs (509) – was on place 2 in 2015
2. Medical optical instruments, devices, and endoscopes (406)
3. Medical electronic instruments and devices (285)
4. Medical polymer material and products (249)
5. Devices and instruments for OR, IR, and Doctor’s consulting room (141) – superseded dental care equipment.

According to the NMPA report 2016, top of the list of registrations of foreign class II and III products (including IVD) were the USA followed by Germany, places 3, 4 and 5 were held by Japan, United Kingdom and Korea.Further information concerning this topic can be obtained from:Cisema GmbHTel.: +49 89 4161 7389–00Fax: +49 89 7484 9956info@cisema.dewww.cisema.com