News

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

Simplified Registration of Cosmetics.The registration procedure for conventional cosmetics at Shanghai FDA has been simplified.In February 2017 NMPA published two new regulations, i.e. NMPA Ann, . # 7, 2017 (Filing Management of First Import Non-special Use Cosmetics through Shanghai Pudong) and NMPA Ann. #10, 2017 (Procedures for Filing Management of First Import Non-special Use Cosmetics through Shanghai Pudong)Based on these regulations, which are preliminarily valid for a test period (01.03.2017 to 21.12.2018) a simplified filing process for conventional cosmetics is applicable.The new regulations are only valid for cosmetics imported through Shanghai Pudong New Area. The so-called China-Responsible is a new concept in cosmetics management aspect. The China-Responsible, who has to be registered in the Shanghai Pudong New Area, is not just a legal agent for filing, but also functions as importer and distributor.The advantage of this new procedure is that the filing for conventional cosmetics at SH FDA can be made in one day, whereas the official way through NMPA registration may take up to three months. On top, the certificate issued by SH FDA does not have to be renewed after four years.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

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

Successful Project Launch of Chery Jaguar Land Rover (CJLR) – Congratulations from Cisema on this great success.The Jaguar Land Rover Group recently launched the X260L project – the first Jaguar entirely produced in China.In this connection Hangzhou Zhongce Rubber Co. Ltd. was honored for their excellent product quality and management skills which contributed greatly to the successful project launch. In the past 3 years, Hangzhou Zhongce Rubber Co. Ltd. went through a comprehensive supplier development program held by Cisema.We at Cisema are happy about this great achievement and will continue to assist with advice and support.

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

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

After the successful completion of a project for a Swiss medical device company, we were entitled by the “Switzerland Global Enterprise” (Swiss Chamber of Commerce) to carry the title „Certified Expert“.

NMPA simplifies registration of dietary supplements. At the end of February 2016, NMPA[1] published the revised administrative regulation for the registration and registration of food supplements by way of Notice No. 22. It will enter into force on July 1, 2016 and is a further step towards implementing the new food safety law in China, which was passed by the NPC[2] in April last year.The new Directive distinguishes between vitamin and mineral supplements and other food supplements. A positive list of authorised ingredients will also be introduced; a first draft was published in February 2016. Simplified regulations will apply to products made from these ingredients in the future.NMPA registration for vitamin and mineral preparations whose ingredients are on the positive list is no longer required. They only have to be registered once at the NMPA counter before the first import and can then be imported indefinitely.All other dietary supplements whose ingredients are on the positive list must still be registered with the NMPA, but after that date there is no need for re-registration after five years. Food supplements can then be imported indefinitely after a one-time registration at the NMPA counter.For all other dietary supplements whose ingredients are not on the positive list, nothing changes. They must still be registered with the NMPA and re-registered every five years.MOF[3] prevents cross-border Internet trade in food supplementsOn 7 April 2016, the MOF revised its rules on cross-border Internet trading (CBEC - Commodities Traded through Cross-Border E-Commerce) by issuing No. 40. In this context, a positive list was adopted listing the products which may continue to be traded across borders via the Internet. The entire Healthfood area is explicitly excluded. The Chinese customs authorities and CIQ[4] are responsible for the enforcement of the new regulation.Further information on the topics mentioned can be obtained from:Cisema GmbHTel.: +49 89 4161 7389 – 00Fax: +49 89 7484 9956info@cisema.dewww.cisema.de[1]China Food and Drug Administration[2]National People's Congress[3]Ministry of Finance[4]China Inspection and Quarantine Office

China RoHS is extended.On 03.02.2016 a revised version of the pollutant regulations - RoHS 2.0[1] - was published by the responsible government organisations (MIIT[2], SDPC[3], MOST[4], MOF[5], MEP[6], MOFCOM[7], customs and AQSIQ[8]), the directive comes into force on 1.7.2016 and is based on the identical European directive.Here are the most important innovations:

• From now on, the RoHS directive also applies to electronic and electrical devices and consumer electronics up to 1500V DC and 1000V AC. The import of these products is prohibited if they do not comply with Chinese regulations.
• The definition of hazardous substances is clarified:Restrictions apply not only to the pollutants themselves but also to their compounds, i.e. cadmium, lead, mercury and chromium (VI) and their compounds.
• New packaging and labelling requirements require precise information on the pollutant contained and its localisation in the product.The competent authorities shall introduce stricter monitoring of the arrangements:
  1. From July 2016, Customs is to carry out the inspection of RoHS-relevant products.
  2. The first Compliance Management Catalogue and Conformity Assessment System are to be published in October 2016.
  3. After a transition period of one year, only RoHS relevant products that meet the requirements of RoHS 2.0 may be imported, traded and used in China.

Further information on the topics mentioned can be obtained from:Cisema GmbHTel.: +49 89 4161 7389 - 00Fax: +49 89 7484 9956info@cisema.dewww.cisema.de[1]Restriction of Hazardous Substances[2]Ministry of Industry and Information Technology PR China[3]State Development Planning Commission PR China[4]Ministry of Science and Technology PR China[5]Ministry of Finance PR China[6]Ministry of Environmental Protection PR China[7]Ministry of Commerce PR China[8]General Administration of Quality Supervision, Inspection and Quarantine PR China

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

The import of used machines to China will become much easier: AQSIQ (State Administration of Quality Supervision, Inspection and Quarantine) regulates the process anew with Communication No. 145 2014.Since the beginning of 2015, the complex and time-consuming application for the import of used machines at CIQ (China Inspection and Quarantine) has been eliminated.From now on, the Chinese customs tariff number can be used to determine whether it is possible to import a used machine or plant and which further steps are necessary for the import - for example, a pre-shipment inspection by the CCIC (China Certification & Inspection Group) or an Automatic Import License.The new regulation makes such exports easier to plan and significantly reduces the time and thus also the financial expenditure.Further information on the topics mentioned can be obtained from:Cisema 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