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CFDA: Chinese Product Names Compulsory for Foreign Medical Devices
This new requirement is to ensure that users of medical devices have a better understanding of their functions. In its announcement the Chinese State Council stated similar requirements for naming medical devices in the USA, Europe, Japan and other countries.
In choosing Chinese product names several requirements need to be followed to be in compliance with the CFDA regulations. Some of the requirements include:
- Choosing a product name that directly refers to the product’s use/function
- If the device has different model versions and functions, there should be a common core word with not more than three additional words
- Product names should not include registered trademarks, company names or symbols
You can find further information about our services for CFDA registration on our website.
It is expected that there will be more announcements, revisions and changes to the CFDA regulations in the near future. In our News section on our website, we will keep you informed regarding the official announcements.
Please do not hesitate to call (UK: +44 2071931135, Rest of Europe: +49 69 2713769150, US: +1 773 654-2673) or email and we will be happy to answer questions.
The 86th International Geneva Motor Show
The 86th International Geneva Motor Show will take place March 3-13, 2016. Attendees, journalists, professionals and representatives will have the opportunity to get up-close and personal with current trends and state-of-the-art technology.
The Geneva Motor show is considered to be one of the most important automotive exhibitions in the world.
A jury consisting of 58 journalists from 22 European countries will nominate the “Car of the Year.” Starting with a total of 29 car manufacturers, the jury agreed on seven finalists. February 15th and 16th the seven finalists participated in a final test drive at the test and research Centre in Mortefontaine, France. Innovation, design, and quality were considered in determining who will be finally chosen.
Visitors of this year exhibition can look forward to more than 200 exhibitors from 30 countries that will be distributed amongst the 7 exhibition areas. In addition, more than 120 pieces will be presented at Geneva Motor Show for the first time ever.
Many of our clients will attend and/or present at the Geneva Motor Show.
All of them successfully tackled the challenge of CCC Certification with us at their side.
China Certification Corporation offers CCC Certification for Automotive Suppliers as well as CCC for Automotive Manufacturers. For manufacturers we offer CCC Certifications and the Complete Type Approvals (including emission and consumption test) to enable sales of vehicles into the Chinese market.
For more information regarding CCC certification, the certification process as well as the associated costs, please visit our website.
For detailed information, please download our free booklet “CCC Made Easy” here. You may also consider our book “A Brief Guide to CCC: China Compulsory Certification”, which can be ordered directly on Amazon here.
Please do not hesitate to contact us by phone (UK: +44 2071931135, US: +1 773 654-2673, GER: +49-69-2713769150) or e-mail us with any questions you may have.
CQC: New GB-Standard for Voluntary Certification of Conductive Charging Systems for Electric Vehicles
In their announcement No. 40 from December 28, 2015 the SAC (Standardization Administration of the People’s Republic of China) and AQSIQ (General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China) jointly issued a new GB-standard GB/T18487.1-2015 “Conductive Charging Systems for Electric Vehicles – Part 1: General Requirements”. It was implemented on January 1, 2016.
The CQC (China Quality Certification Centre) standard involving this rule, CQC14-464234-2014, has been revised accordingly. CQC certification of conductive AC charging systems for electric vehicles can now be applied for on a voluntary basis.
AC charging systems relevant standards are as follows:
- GB/T18487.1-2015 “Conductive Charging Systems for Electric Vehicles – Part 1: General Requirements”
- NB/T33002-2010 “Technical Requirements for Charging of Electrical Vehicles”
- NB/T33008.2-2013 “Inspection and Testing Specifications for Electric Vehicle Charging Equipment – Part 2: AC Charging“
Since its announcement manufacturers can apply for certification in accordance with the new GB-standard or apply for the update of existing certificates with the CQC.
The main regulatory changes are in regards to:
- Increase of products standards in GB/T18487.1-2015
- Authentication mode was added: Type test with follow-up inspection
- New standards in Annex 2 for the inspection requirements of plant quality control have been adjusted.
The Chinese certification authority CQC often publishes important announcements on their website. Check our News-page from time to time where you will find updates regarding new announcements from the certifying authorities.
You can find more information about the Voluntary CQC Mark Certification here.
If you have any questions regarding Voluntary CQC Mark Certification, please don’t hesitate to contact us any time. Write an email or call us directly (UK: +44 2071931135, Rest of Europe: +49-69-2713769150, US: +1 773 654-2673).
CCC: New Implementation Rules for Door Locks and Door Retention Systems
New Implementation Rules for Door Locks and Retention Systems (CNCA-C11-10: 2014) were issued by the CNCA in 2014 and made effective January 1, 2015. Initial CCC certifications that were done in 2015 have been certified to the new Implementation Rules.
Manufacturers who received their CCC prior to 2015 will be required make the necessary changes, and update to the new Implementation Rules before January 1, 2017.
The Chinese certification authorities have allowed a transitional period from January 1, 2015 through January 1, 2017 for changes to existing certificate holders.
The new implementation rules for door locks and door retention system (CNCA-C11-10: 2014) replaces the old regulations CNCA-02C-061: 2005. The underlying GB standard GB15086-2013 remains the same.
The update includes the following main points:
For spare parts the following documents have to be submitted:
For more information regarding the amended implementation rules please contact us.
Also, you can visit us at our booth at the IZB, from October 18-20, 2016 in Wolfsburg, Germany where we will jointly be exhibiting together with the CCAP.
For more information regarding CCC certification, the certification process as well as the associated costs, please visit our website.
You may also consider downloading our free booklet “CCC Made Easy” here. Moreover, you can order our book “A Brief Guide to CCC: China Compulsory Certification”, directly from Amazon here.
CCC: New GB Standard for Busbar Trunking Systems (Busways)
On May 5, 2015 the new GB standard GB7251.6-2015 “low-voltage switchgear and control equipment part 6: busbar trunking systems (busways)” was issued by the Chinese certification authorities. It will come into effect on June 1, 2016 and replaces the current GB7251.2-2006. Until then manufacturers can voluntarily chose if they want to get the certification based on the old or new GB standard.
Certificates with the old standard can be updated during the next annual China CCC follow-up inspection. To do so, manufacturers will need to submit their updated applications to CQC (China Quality Certification Centre) prior to their annual inspection in order to get the required update.
All certificates are required to be updated by May 31, 2017. Certificates that are not updated by this date will then risk the possibility of suspension. Certificates that are not updated by August 31, 2017 will be cancelled.
If new product sample tests are required they should immediately be sent to CQC.
Are you looking for more information regarding new Chinese standards? Do you need more information regarding regulatory updates? If so, please call or email us anytime. We can be reached by phone (UK: +44 2071931135, US: +1 773 654-2673) or email for any questions or concerns you may have.
For more detailed information please download our free booklet “CCC Made Easy” here. You may also consider our book “A Brief Guide to CCC: China Compulsory Certification”, which can be ordered directly on Amazon here.
CCC: Update of Implementation Rules for Luminaries
The detailed Implementation Rules for luminaries were published in September of 2014 by the Chinese Certification authority CQC (China Quality Certification Centre). Before the CNCA has updated the implementation rules (CNCA-C10-01:2014).
Due to technology developments in this sector at the end of 2015 the regulations were further specified.
With the announcement made end of 2015 several changes were implemented. A few of the changes include:
- Changes of requirements for test samples
- Changes of the frequency for follow-up audits, man days and requirements for the mode of supervision
- Two new types key components for the control device of LED luminaries were added
- Amendment of regular test and verification test methods of operation for grounding of luminaries and control device products
After the announcement these updates were immediately implemented and are mandatory for luminary devices.
If you want to learn more about the newly updated Implementation Rules please contact us directly. We will be glad to answer any questions or concerns you might have.
For more detailed information please download our free booklet “CCC Made Easy” here. You may also consider our book “A Brief Guide to CCC: China Compulsory Certification”, which can be ordered directly on Amazon here.
Are you seeking for more information about this CQC announcement or do you want to know if there will be new CCC implementation rules also for your product? Then contact us! Write us an Email or call us: Germany: +49 69 271 3769 150, UK: +44 2071931135, US: +1 773 654 2673.
IZB October 2016: China Certification Corporation and CCAP will be jointly represented at the IZB -International Suppliers Fair- in Wolfsburg, Germany
China Certification Corporation and the CCAP (China Certification Centre for Automotive Products) will be jointly represented at the IZB (International Suppliers Fair; www.izb-online.com/en) in Wolfsburg, Germany. Don’t miss the opportunity to meet CCAP representatives as well as representatives from China Certification Corporation at IZB in person from October 18-20, 2016 in hall 3, booth number 3306. We are looking forward to exchange with you about the opportunities and challenges of CCC-certification.
The IZB takes place every other year and is one of the leading trade fairs for the automotive supplier industry. It draws visitors and exhibitors from all over the world. This year’s IBZ theme will be “Mobility Goes Digital”.
The CCAP is the Chinese certification bureau, conducting automotive certifications on a national as well as international level, based on the Chinese guidelines and laws such as the GB Standards and the Implementation rules. Their goal is to maintain the high standards and regulations set out by the Chinese government in regards to safety.
To implement the objectives, the CCAP employs specialized, professional auditors who are trained at state institutions focusing in the area of product certification. All of the auditors have extensive experience in the automotive sector. In addition, the CCAP have testing laboratories which are accredited by CNAS (China National Accreditation Service for Conformity Assessment). These test labs are focused on safety and flammability testing of automotive products.
MPR China Certification GmbH was the only non-Chinese company awarded as an “Outstanding Certification Company” by the CCAP in 2013.
Through the repeated joint trade fair appearance the excellent cooperation with the CCAP is to be further strengthened so that our customers can continue to benefit from our excellent relations with the Chinese certification authority.
Please come visit us in hall 3, booth number 3313. We are looking forward to seeing you there!
We are part of the CERTANIA-Group.