CFDA: China Focuses on the Registration of Medical Devices

For the next few years the Chinese government will focus on the development of the market for medical devices. This point was announced as a part of the 13th Five-Year Plan. This year is the first year the five-year plan comes into force with implementation also starting. This may lead to serious changes in the Chinese medical market which will influence CFDA registration.

Chinese manufacturers of medical devices are in a difficult situation. It is estimated that multinational corporations such as GE, Philips and Siemens have approximately 70% of the market share. The market share of Chinese manufacturers of high-quality medical devices is estimated to be only at about 10-20%.

The five-year plan is designed to strengthen domestic manufacturer’s market share. This will also be done though regulatory changes. A large number of foreign manufacturers of high-quality medical devices were required to undergo clinical trials during the registration process. After a long-term review of countless clinical trials, it was determined that up to 80% of the clinical trials were not properly performed or falsified. This has led the CFDA to increase the regulatory requirements for clinical trials. These new requirements protract the registration process and make it much more difficult for foreign manufacturers.

The China Food and Drug Administration (CFDA) understands the importance of maintaining an appropriate level of over-sight for the registration process. For this reason, the CFDA has already publicly announced that a more streamlined assessment process is in the works to shorten CFDA registration. The new plan allows manufacturers of Class II products (imported only) and Class III products (domestic and imported) to apply for a “priority review”. However, this is only possible if one of the following three points applies. The product is part of a National Science and Technology Major Project, part of the National Key Research and Development Plan, or it provides significant benefits in the diagnosis or treatment of cancer, geriatric or pediatric diseases.

Despite the changes to the registration process, the Chinese market for medical products offers enormous potential with high growth rates. In order to take advantage of this potential, manufacturers are required to go through the CFDA registration. Due to the changes in regulations, applicants should work with a competent consulting company to save costs and complete the process in a timely manner.

It is expected that there will be more announcements, revisions and changes to the CFDA regulations in the near future. You will find updated information in our news section on our website, where we will keep you informed regarding official announcements.

 

Please do not hesitate to call (UK: +44 2071931135, Rest of Europe: +49 69 2713769150, US: +1 773 654-2673) or e-mail and we will be happy to answer questions.

China might Relax Their Quotas for Electric and Hybrid Vehicle Sales

We recently wrote about the quotas in China for electric and hybrid vehicles in our News Section. The importance and sales volumes for electrical cars in China have been rising over the last two years. In accordance with its new environmental consciousness, Beijing is planning to implement a rule which stipulates that a distinct part of the cars sold in China has to be equipped with an electric or hybrid motor. Beijing is now planning to relax this quota.

The Chinese Ministry of Industry and Information Technology initiated a legislative proposal in autumn last year that requires car manufacturers who sell cars in China, among those BMW, VW and Daimler, to collect credit points by shifting 8 percent of their sales to electric and hybrid vehicles in 2018. The quota would then increase to 10 percent the following year and 12 percent in 2020. Car manufacturers will incur penalties for not meeting the required targets.

China is one of the most important markets for the German automotive industry, so these newly announced quotas cause concern for the manufacturers. Currently Volkswagen is selling only a couple of hundred electrical vehicles to China. If the quotas are not met, production would need to be dramatically scaled back, or credit points need to be purchased to make up the difference.

Now it looks as if Beijing is about to loosen the legislative proposal. So far, there is no written statement regarding this issue.

Electric vehicles need CCC certification for the Chinese market. Are you a manufacturer of electric vehicles and need information regarding CCC? For further information regarding CCC or the detailed implementation rules please contact us via e-mail or telephone (UK: +44 2071931135, Rest of Europe: +49 69 2713769150, US: +1 773 654-2673).

For additional 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.

Faulty Airbags: Recall of BMW 3 Series and X5 Series in China

According to the AQSIQ (General Administration of Quality Supervision, Inspection and Quarantine), BMW (China) Automotive Trading Co., Ltd. has been recalling several BMW 3 and X5 series vehicles since March 6, 2017.

Affected are 171 vehicles of the 3 series, which were produced an imported between June 10, 2000 and November 26, 2001. With regards to the X5 models, a total of 183 vehicles are affected, produced and imported between October 18, 2000 and January 27, 2003.

In the case of the affected vehicles, incorrect airbags were installed in the course of after-sales replacements. According to the authority when the airbag is triggered parts of the metal filter might come lose during to the ignition of the propellant which can lead to injuries of the occupants and/or may adversely affect the function of the airbag.

According to the car manufacturer, airbags used in the seats are not affected by the recall.

 

 

The purpose of the metal filter in an airbag is to block any solid particles that are released during the ignition of the propellant and to prevent them from damaging the airbag itself and/or causing injuries for the passengers.

Owner of the affected vehicles are asked to get the airbags replaced at their dealer as soon as possible. Remaining Airbags will be replaced during the regular maintenance checks. All repair and exchange costs will be covered by BMW China.

As of right now airbags are not subject to mandatory CCC certification. Airbags are tested in the course of the complete car homologation. Since it is not mandatory, it is not possible to get CCC certification for airbags.

For more information about CCC in general, the process and the associated costs, please visit our website and our News Section where you will find current updates twice a week.

Please do not hesitate to contact us for further details and consultation. You can contact us via e-mail, or call us (UK: +44 2071931135, Rest of Europe: +49 69 2713769150, US: +1 773 654-2673).

You can also check out our free CCC-Brochure, which can be downloaded right here as a PDF file or you consult our English textbook “A Brief Guide to CCC: China Compulsory Certification”, which can be found directly here on Amazon.

CCCF for Fire Protection Clothing and Equipment

In our news section, we have written about the need for fire protection products as well as fire protection equipment to get CCCF certification for China. The CCCF certification is a CCC certification for fire safety products.

Similar to other CCC certification, fire protective clothing and fire protection equipment have a GB Standard and relevant Implementation Rules for the Chinese product certification.

The Implementation Rules are:

• CNCA-C18-04:2014 (Implementation Rules of accessories for fire protection products)
• CCCF-XFZB-01(A/0) (Implementation Rules for fire-fighting equipment and personal fire-fighting equipment)

The National Chinese standards (GB Standards) which determine the testing criteria are as follows:

• Fire protection Helmets (GA634-2015 and GA44-2015)
• Firefighting Clothing (GA10-2014)
• Fire Protection Gloves (GA7-2004)
• Fire Protective Shoes (GA6-2004)

 

Are you a manufacturer of fire protection equipment and need a CCCF certificate for fire safety products? Please do not hesitate to contact us for further details and detailed consultation. You can contact us via email, or call us (UK: +44 2071931135, Rest of Europe: +49 69 2713769150, US: +1 773 654-2673).

For general information on CCCF, the certification process, the associated costs, or further GB standards, please visit our website.

For more additional 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.

 

HAF 604: China Plans to Build a Fleet of Floating Nuclear Power Plants

With the permission of the Chinese government the China General Nuclear Power Group (CGN) started building the first floating nuclear power plant in November of 2016. The expansion of the Chinese capacity to generate nuclear energy was already published in the last five-year plan in March of 2016. Designed in the form of large vessels several of these floating nuclear power plants are planned to be constructed by 2020. According to media reports, each vessel will cost up to 400 million Euro.

With the development and production of this nuclear power plant, China is aiming to provide clean energy and heat to remote islands and coastal areas. Existing diesel-powered generators are too inefficient. The floating nuclear power plants would have the advantage of providing a much more efficient energy supply in the long term with a planned output of 200Mwt per vessel.

China is also continuing to work on the expansion of nuclear power plants on the mainland with 36 nuclear power plants currently in operation. Another 21 are already under construction. Companies in the nuclear power industry can continue to expect continued growth potential in the Chinese nuclear market. The topic of HAF 604 certification for components of nuclear plants is an important issue for many manufacturers. For many years the Chinese market for nuclear equipment will continue to grow. The HAF 604 registration will enable exporters to export their products to China.

If you are interested in HAF 604 registration for the components of nuclear equipment, please do not hesitate to contact us.

• We will provide you with a non-binding check to see whether your products need HAF 604 Certification.
• We will provide you with a non-binding, transparent, all-inclusive quotation stating the costs and time needed to get the HAF 604 certification.
• We will take over all communications with the Chinese test lab and certification authorities.
• If product tests and a factory inspection by the NNSA are needed, we take over all the necessary steps.
• We pay all application fees and testing fees needed at the Chinese authorities.
• We will do everything to ensure you a smooth and quick HAF 604 Certification process.

We would like to help with any questions regarding the HAF 604 Certification or the Chinese nuclear market in general. Send us an Email or call us (UK: +44 2071931135, Rest of Europe: +49 69 2713769150, US: +1 773 654-2673). It would be a pleasure to support you.

 

CFDA: New Provision for the Recall of Medical Devices Published

The latest revised regulations for the supervision and administration of medical devices was implemented on June 1, 2014 and includes requirements for the recall of medical devices. The China Food and Drug Administration (CFDA) organized the revision of the provision for the recall of medical devices. The provisions for the recall of medical devices (CFDA No. 29) were adopted at the CFDA executive meeting on January 5, 2017 and will be effective as of May 1, 2017.
Medical products need a CFDA registration in China.

The following products must be recalled according to the new provision:
1) Products that present undue risks that could endanger human health and safety during normal use
2) Products which do not comply with the prescribed standards and technical requirements
3) Products which are not produced according to the production and quality standards.

The manufacturer is responsible for ensuring that only products conforming to relevant Chinese quality standards are marketed within China. The manufacturer is also responsible for a recall, if necessary, for products that are defective or fall within the above stated regulation regarding recall. If a manufacturer of medical devices fails to remove non-compliant products from the market within a reasonable period of time, the manufacturer will bear the full responsibility and will likely face steep fines, and/or penalties.

There are three different types of recalls, which are classified according to the severity of the deficiencies. A severe deficiency is present if the use of the medical device can result in serious health damage. In case of serious defects, the recall must be announced within one day. A median deficiency is referred to when the medical device could cause temporary or reversible health damage. In the case of medium deficiencies, the recall must be notified within three days. A slight deficiency is given if the use of the medical device could possibly cause minor health damage. In the case of slight defects, the recall must be notified within seven days.

The recall of a medical device is a very complex process because it has to be done at different levels of authority. Furthermore, not only the manufacturer, but also the “legal agent” as well as the user of the medical device is involved in the process. Therefore, the support of a competent consultancy can make the process much easier.

The purpose for these changes is to promote further improvement of China’s medical device standards system, and build a solid foundation for ensuring the safety and effectiveness of medical devices. It is expected that there will be more announcements, reforms and changes to the CFDA regulations in the future. In our “News” section on our website, we will keep you informed about official announcements and changes to the regulations.

Please do not hesitate to call (UK: +44 2071931135, Rest of Europe: +49 69 2713769150, US: +1 773 654-2673) or e-mail and we will be happy to answer questions.

CCC: 68th Toy Fair 2017 in Nuremberg

This year one of the most important events in the toy industry, the 68th Spielwarenmesse 2017, took place at the Nuremberg Exhibition Grounds in Nuremberg, Germany from January 31, 2017 to February 4, 2017. This toy fair is well-known toy companies, buyers, retailers and smaller start-ups.

A total of 2,871 exhibitors from more than 60 countries were represented, with an attendance of more than 73,000 visitors. This year the fair had one million exhibited products, with over 75,000 new products releases. Compared with Spielwarenmesse 2016, the number of trade visitors grew by 3.2%, with an increase of international traders and buyers growing by a substantial 2%.
The Spielwarenmesse is known world-wide as one most important toy fairs, and with increases like this it will remain so.

The growing number of CCC certifications is also showing the growing international interest in the Chinese market. More and more well-known manufacturers are pushing for the Chinese market and must go through the associated CCC certification in order to do so. MPR China Certification GmbH accompanies their customers right from the start and supports them to help along with a smooth certification process.

If you are looking for more information about CCC for toys, please do not hesitate to contact us directly. Just send us an e-mail or give us a Call at UK: +44 2071931135, Rest of Europe: +49 69 2713769150, US: +1 773 654-2673.

For more information about CCC in general, the process and the associated costs, please visit our website.

You can also check out our free CCC-Brochure, which can be downloaded right here as a PDF file or you consult our English textbook “A Brief Guide to CCC: China Compulsory Certification”, which you can found here directly on Amazon.