Kategorie-Archiv: News

China – CCC Certification Obligation Lifted for Numerous Products

China – CCC certification obligation lifted for numerous products.

On 15.06.2018 the authorities SAMR (State Administration for Market Regulation) and CNCA (Certification and Accreditation Administration of the People’s Republic of China) published in their announcement 11/2018 that for some product groups the mandatory certification according to CCC (China Compulsory Certification) is going to be converted into a manufacturer’s declaration as of 01.10.2018, similar to the CE marking. The previously obligatory factory inspection is no longer necessary. Instead, documentation on product safety and safety risks will be required.

A distinction is made between two types for the manufacturer’s declaration process:

Type A
Test reports can be used from any accredited test laboratory and possibly even from a companies’ own laboratory.

Type B
Test laboratories that have been accredited for CCC must be used.

Companies wishing to retain the previous method of the CCC certification can apply for this.

The information currently provided on the implementation of the Manufacturer’s Declaration and the transition is still incomplete. We expect further details by October. In particular: how, where and from what date the manufacturer’s declarations are to be submitted.

Affected product groups for a declaration of conformity:

Product group Applicable implementation rule Type
Low voltage switch equipment: complete power switch equipment, bus main line system (bus slot), distribution board, low voltage set of reactive power compensation device CNCA-C03-01:2014 A
Low-power motor CNCA-C04-01:2014 B
Small AC arc welder;

AC arc welder;

DC arc welder;

TIG arc welding machine;

MIG/MAG arc welder;

Arcing welding machine;

Plasma arc cutter;

Plasma arc welding machine;

Arc welding Transformer anti-electric shock device;

Welding cable coupling device;

Resistance welder;

Silk delivery device;

TIG welding torch;

MIG/MAG welding gun;

Electric pliers.

CNCA-C06-01:2014 B
Motor-Compressor CNCA-C07-01:2017 B
Equipment with nominal rated voltage less than or equal to 5V DC, nominal rated power consumption less than 15W (or 15VA) and no rechargeable battery in information technology equipment, audio and video equipment (Category III equipment) CNCA-C08-01:2014

CNCA-C09-01:2014

B
Motor Vehicle Interior Trimming CNCA-C11-09:2014 B
Motor vehicle door locks and door retainers CNCA-C11-10:2014 B

 

It was also announced that a reduction of the CCC certification scope was made. Several products are not requiring the certification anymore. The amendment will come into force on the date of publication, that is June 16th 2018.

The responsible certification organizations are instructed to cancel affected certificates immediately.

The certification organizations offer the companies concerned to convert their existing CCC certificates into voluntary certification. Under certain circumstances, the CCC logo may no longer be used, but may have to be changed to the logo of the certification organization. Voluntary certification can make sense to distinguish a company from its competitors or due to consumer expectations.

We consult and support you in the changeover to the new system, as well as in the transfer of the previous CCC certification to a voluntary certification for the Chinese market.

No longer relevant for certification:

Product group Applicable implementation rule
Plug socket and appliance couplers (for industrial use) CNCA-C02-01:2014
Construction site complete equipment (ACS); power distribution equipment for public grid CNCA-C03-01:2014
Non-flammable liquid electric spray gun; electric scissors; threading machine; electric chain saw; electric planer; electric pruning shears CNCA-C05-01:2014
Video(display) tube; antenna amplifier CNCA-C08-01:2014
Computer game machine; computer learning machine CNCA-C09-01:2014
Motorcycle engine CNCA-C11-03:2014
Motor vehicle horn CNCA-C11-05:2014
Motor vehicle brake hose / tube CNCA-C11-06:2014
Motor vehicle fuel tank CNCA-C11-11:2014
Modem (with card); ISDN Terminator CNCA-C16-01:2014
Flammable gas alarm products; electrical fire surveillance system CNCA-C18-01:2014
Aerosol fire extinguishing device CNCA-C18-03:2014
Motor vehicle theft alarm system CNCA-C19-01:2014
Wireless LAN products CNCA-C20-01:2007
Concrete antifreeze CNCA-C21-01:2014

 

For further information on the above topics, please contact:

Cisema China Certification GmbH
Tel.: +49 89 4161 7389 – 00
info@cisema.de
www.cisema.com

Conquer China’s Beauty Market

Webinar: Conquer china’s Beauty Market.

Join our new webinar, which will help you conquer the Chinese beauty market. On June 6th 2018 Anna Fischer will inform and answer questions about issues like CFDA registration (process, duration, costs?), the distinction between non-special and special cosmetics, animal studies and other do’s and don’ts you should know about on your way into China’s beauty market.
Please register here:

Important News Concerning CCC Marking

Certification in China – Important News Concerning CCC Marking

On 15.3.2018 the certification authority CNCA (Certification and Accreditation Administration of the P.R. China) announced on short term (announcement 10/2018) that the issuance of Permissions of Printing (PoP) for marking products with the CCC-logo (China Compulsory Certification) will be stopped as of 20.03.2018. According to the announcement, the owners of CCC certificates can start the marking immediately after receipt of the CCC certificate, provided they adhere to the guidelines. This procedure is similar to other well-known certification marks like E, CE or UL.

Previously issued Permissions of Printing for CCC do not require any changes of documents or marks.

The Chinese certification authorities shall finalize their preparations for administration and supervision of the CCC marking process before 01.05.2018 and take over from CNCA as of 01.05.2018.

Against currently known information, some certification organizations will start to publish a form for checking and documentation of the CCC marking in their application forms. The certification authorities will verify the implementation during factory inspections. Some certification organizations have not yet published all details for the implementation of the CNCA announcement, therefore, further info is expected within the next few weeks.

The CNCA department for the administration of the Permissions of Printing of CCC will be shut down as of 01.06.2018.

Furthermore, it was announced that the previously required additional characters in the CCC logo as for example S (Safety), EMC (Electromagnetic Compatibility), S&E (S + EMC) und F (Fire Safety) will be omitted.

Additional characters in the logo are no longer required, see example:

The marking of cables and brake hoses by the characters „CCC“ instead of the CCC logo continues to be acceptable.

 

Registration of Cosmetics Might Soon be Possible Without Animal Tests

Registration of Cosmetics Without Animal Tests.

On 05.02.2018, the NIFDC (National Institutes for Food and Drug Control) – a unit under the CFDA (China Food and Drug Administration) – published a draft on two alternatives to animal testing: One for skin and one for eye irritation.

The draft was open for public comment until 15.02.2018 and clearly indicates a major step towards the improvement of China’s technical cosmetics regulations and the replacement of animal testing in the future. Cisema will follow this development closely and will inform you as soon as the CFDA notice regarding the finalization of the two alternative methods is published.

For further information on this topic please contact:

Cisema GmbH
Tel.: +49 89 4161 7389 – 00
info@cisema.de
www.cisema.com

Trade Fair Dates

Trade Fair Dates.

Cisema regularly contributes to exhibitions – for instance in form of presentations in cooperation with professional associations or trade fair organizers.
2018 is also a busy year for us as we will be present at numerous exhibitions:

Medical Devices

28 Jan – 01 Feb            Arab Health Dubai, Dubai
23 Mar – 25 Mar           China Med, Beijing
02 Apr – 04 Apr            Rehacare & Orthopedic China, Guangzhou
11 Apr – 14 Apr            China Medical Equipment Fair Spring (CMEF), Shanghai
17 Apr – 19 Apr            Medtec Europe, Stuttgart
07 May – 09 May          Hong Kong International Medical Devices and Supplies Fair, Hong Kong
07 Jun – 09 Jun            China International Assistive Products Exposition (CIAPE), Beijing
09 Jun – 12 Jun            Sino-Dental, Beijing
17 Jul – 19 Jul               Florida International Medical Expo (FIME), Orlando
29 Aug – 01 Sep           China Dental Show (CDS), Shanghai
26 Sep – 28 Sep           Medtech China, Shanghai
11 Oct – 13 Oct            Care & Rehabilitation Expo China, Beijing
29 Oct – 01 Nov           China Medical Equipment Fair Autumn (CMEF), Shenzhen
31 Oct – 03 Nov           DenTech China, Shanghai
12 Nov – 15 Nov          Medica, Düsseldorf
23 Nov – 28 Nov          Greater New York Dental Meeting, New York

Cosmetics & Health Food

10 Mar – 12 Mar          China International Beauty Expo (CIBE), Guangzhou
15 Mar – 18 Mar          Cosmoprof Worldwide, Bologna
22 May – 24 May         China Beauty Expo, Shanghai
24 May – 26 May         Biofach China, Shanghai
17 Oct – 18 Oct           Cosmetic 360, Paris
14 Nov – 16 Nov         Cosmoprof Asia, Hong Kong

You are already our customer and would like to receive an update on your project progress?
You are not a customer but have questions regarding the registration of your product in China and would like to get to know us in person?

Let us know if you plan to visit one of the above mentioned trade fairs and we would be delighted to meet you. Please contact us to arrange a suitable time (E-Mail: afischer@cisema.com).

Additional CCC Certification Organization for Automotive Parts

Accreditation of CCC Certification Organization CAQC for Automotive Components.

The CNCA (Certification and Accreditation Administration of the People’s Republic of China) announced with its Notice No. 43-2017 that the CAQC (Cyberspace Administration of China) is allowed to process CCC (China Compulsory Certification) certification for product groups in the automotive sector. Among others: seat belts, horn, brake hose lines, exterior lighting and light-signalling devices, indirect vision devices, fuel tanks (metal and plastic), seat and headrests, child restraint systems. The previous certification scope included solely: interior and insulation materials, door locks and hinges.

Thus, applicants in the automotive sector have a new option to the previous duopoly of the organizations CQC (China Quality Certification Center) and CCAP (China Certification Center for Automotive Products).

For further information on the above topics, please contact:

Cisema GmbH
Tel.: +49 89 4161 7389 – 00
Fax: +49 89 7484 9956
info@cisema.de
www.cisema.de

CFDA: Funding for Testing of Medical Devices

Funding for Testing of Medical Devices.

On 17.11.2017 the CFDA (China Food and Drug Administration) published a notice announcing that fee-charging tests (also referred to as sponsored tests) are accepted as part of the CFDA registration of medical devices (No. 2017-187). In April 2017, the MOF (Ministry of Finance) had abolished most test fees for foreign products, resulting in a bottleneck due to laboratories going on strike. This policy evidentially failed and by re-introducing the option of fee-charging tests, a compromise between the State Council, CFDA and test laboratories is attempted. First laboratories have started to provide both test options. However, there are two uncertainties regarding fee-charging tests: Firstly, the timeline is unpredictable because the CFDA failed to specify a timeline in their regulation. Secondly, a failed test will result in the termination of the test and, subsequently, force the manufacturer to initiate a new test application.

For further information on this topic please contact:

Cisema GmbH
Tel.: +49 89 4161 7389 – 00
Fax: +49 89 7484 9956
info@cisema.de
www.cisema.com

15 Years in China Business

15 Years in China Business

Cisema celebrates its 15th anniversary – a joyful occasion to take a look at its company history.

The company was founded in 2002 by Stefan Fischer, shortly after China had become the 142nd member of the World Trade Organization (WTO).

China, the world’s most populated country, had just opened its doors and Stefan Fischer knew that this would bring great opportunities and challenges. He decided to build Cisema and to use his knowledge and skills to help companies enter China’s sales and procurement market.

Based on this idea, Cisema has developed a range of services with the main focus on certification, registration and licensing in the People’s Republic of China. Since China’s WTO accession, the Chinese government has made great efforts to adapt non-tariff trade barriers to international guidelines.

For example, in 2003, the current „CCC“ (China Compulsory Certification) was introduced in order to enforce uniform safety standards for electronic components, vehicles and their components. In 2006, the „CML“ (China Manufacturer License), the regulatory framework for pressure vessels, was modernized. New registration regulations for medical technology, pharmacy, cosmetics and nutritional supplements were issued in 2014 by the „CFDA“ (China Food and Drug Administration).

In addition to certification services, it is Cisema’s mission to help its customers make their purchases in China more effective with less effort. Cisema’s service packages include sourcing, supplier audits, pre-shipment inspections, as well as supplier development improving the process capability of Chinese suppliers.

Our customers have succeeded with their missions and have inspired Cisema to succeed and grow over the past 15 years. We started with one office in Munich and have grown to 5 offices across China as well as offices in Vienna, Chicago and Yangon. This makes it clear that Cisema keeps its promises and is always a good partner providing reliable support to its customers in penetrating the Chinese market.