CFDA: CFDA Releases the 2015 Annual Report for Medical Device Registration

Recently the CFDA released the “2015 Annual Report for Medical Device Registration”, which includes the overview of medical device registration for 2015. Overall in 2015, the CFDA has approved 7,530 registrations, with 1,297 applications being rejected. The report also includes a listing of the top device categories with medical optical instruments and endoscopic equipment being the largest category, followed by implantable materials and artificial organs, and then dental care equipment.

The report shows the origin of the registrations, with more foreign devices being registered than domestic. The conclusion could be that China to some extent, still relies on foreign supply of high-end medical devices.

The report indicates that the US, Germany, Japan, UK and Korea were among the top 5 countries which registered the highest amount of medical devices. Generally, it can be said that the 5 mentioned countries are strong players in the global medical device market.

The Chinese medical devices market has been gaining worldwide attention with an impressive annual growth rate of nearly 20% in the last decade. This growth makes the market attractive for foreign companies.

With such a large number of rejected applications, it is obvious that professional consultation is indispensable in the process of the CFDA application. MPR China Certification GmbH/China Certification Corporation can assist you with your CFDA product certification.

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: China Remains the Largest Growth Market for Premium Auto Manufacturers

The year 2015 was extremely profitable for the premium auto manufacturers Mercedes, Audi and BMW. All of them were able to post record-breaking sales figures. The market share of the three OEMs is comparatively equally distributed. However, Mercedes managed to generate a revenue-growth of 13.4 % from the previous year. The Chinese automobile market has become increasingly more important for the premium manufacturers. No other market shows the kind of growth that is found in the Chinese market.

Currently, Mercedes’ focus is on the E-series which was one of the main growth drivers in the recent years. Audi lately has concentrated on their SUV series, which generated the highest growth in the last years. However, Audi’s flagship vehicle is still the A6 which has been the top selling business limousine for years. BMW has concentrated their efforts on new products, such as the recently introduced the BMW X1 long version.

All of the premium manufacturers recognized that the Chinese market still has huge un-tapped potential. The extension of their dealer network has been the focus of all of these premium manufacturers. Mercedes currently has 500 dealers and Audi plans is to reach 500 dealers by 2017. BMW has been working over the last years to meet the demand for more dealers as well. They are currently on pace with both Mercedes and Audi.

The huge potential of the Chinese automobile market, not only strengthen the OEMs but also the automotive supplier network as well. Many different types of automotive parts produced by suppliers are required to have CCC certification. It is important to check if CCC is needed to avoid problems.

For more Information about CCC certification, the certification process and the costs associated with CCC certification please check our website. 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.

Please do not hesitate to contact us by phone (UK: +44 2071931135, US: +1 773 654-2673, Rest of Europe: +49-69-2713769150) or e-mail us with any questions you may have.

CFDA: 21st China Beauty Expo Held in Shanghai

From May 18th-20th, 2016 the 21st China’s Beauty Expo (CBE), a beauty and cosmetic fair was held in Shanghai. This is one of the most important beauty shows in Asia. In 2014 it was awarded as a one of the “Top 100 World Trade Fairs” by the Imp-Exp Executive Magazine.
The CBE show hosted suppliers, manufacturers and distributors in the cosmetic and beauty area. The participants and attendees shared the latest trends and innovations. Exhibitors from around the world showed presentations on trends, design, and color or from industry experts like Velvet (France), Martine Leherpeur Conseil & Xiaoqiao (France / China) and Beauty Streams (USA). The show also highlighted the latest in packaging, raw materials, OEM/ODM and production equipment.

For the second time the Business Meetings Asia were part of the CBE. The half-day event gave participants the opportunity to obtain information, make new contacts and network with over 50 manufacturers of makeup, perfume and skin care products. The CBE is a good base for companies to make the contacts necessary for entry into the Chinese cosmetics market.

It is important to note that cosmetic products must be approved by the CFDA (China Food and Drug Administration) prior to being shipped or sold into China. For cosmetics that are used for special purposes, additional technical review by a special institution affiliated by the CFDA is required during the approval process. In accordance with the “Regulation on the hygiene monitoring of cosmetic products” which was approved by the Chinese Ministry of Health, this applies the following beauty products: hair restorer, colorant for hair, perming products, depilatories, products for breast enlargement or breast reduction, slimming and toning products, deodorant, products for the removal of skin-irritation (e.g. Pigmentation) and Sun Protection.

Please do not hesitate to call (UK: +44 2071931135, US: +1 773 654-2673) or e-mail with any questions you may have.

CFDA Announces 186 New Industry Standards for Medical Products

Certain medical products and devices are required to have prior approval by the CFDA (China Food and Drug Administration Chinese: 国家食品药品监督管理总局) before they can be sold or used in China. In an effort to insure continued safety and effectiveness of medical products, there have been several changes and revisions within the Chinese regulatory framework for CFDA certification.
In March of 2014 the CFDA published a new version of the “Regulations for the Supervision and Administration of Medical Devices” (Chinese: 医疗器械 监督管理条例(修订草案). In its announcement No. 25 and No. 74 of 2016 the CFDA introduced 186 new Industry Standards (abbreviated as “YY Standards”). These industry standards are split in 42 mandatory and 144 recommended standards. However, recommended changes are often a precursor to future mandatory changes to come. Compliance with these new recommended “YY” standards is highly recommended since they may become mandatory at any time with very short notice.

The new standards apply to the following products:

• Implants for surgery
• Disinfection equipment
• Medical extracorporeal circulation equipment
• Dental equipment
• Ophthalmic equipment

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.
 

CCC: New Version of GB Standard GB 18296 for Automobile Fuel Tanks to be Announced

The Chinese authority SAC (Standardization Administration of the People’s Republic of China) is obtaining relevant expert statements in order to update GB 18296-2001 (safety property requirements and test methods for automobile fuel tank). This GB Standard became effective 15 years ago and has not been updated since. The new version will be adjusted according to the latest technological standards.

At this time there is only a draft version which may be changed by the time the final version of the new GB 18296 is released. The new version is similar to ECE-R34 (uniform provisions concerning the approval of vehicles with regard to the prevention of fire risks) and contains among others the following changes:

• Increased requirements for vibration protection of fuel tanks and related test methods
• Increased fire protection requirements for vehicle rollover and corresponding test methods
• Increased requirements on the resistance and fire protection of plastic tanks and corresponding test methods
• Increased requirements for the installation of fuel tanks
• Increased fire safety requirements and test methods for vehicle collisions
• Elimination of the requirement of opening pressure of the safety valve due to the introduction of automatic devices for balancing the internal overpressure or underpressure.

Are you looking for more information regarding the new GB Standard for automobile fuel tanks? Do you have any questions about the application for certification modification? If so, please call or email us anytime. Write us an Email or call us: UK: +44 2071931135, Rest of Europe: +49 692713769150, US: +1 773 654-2673.

Also check our website if you want more information regarding CCC certification, the CCC certification process, CCC costs, and more information about our all-inclusive CCC certification package. You may want to look at our references page to see what some our clients have to say about us.

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.

 

CQC: New GB Standard for the Voluntary CQC Mark Certification of V-Belts for Motorcycles

Starting June 6, 2016 a new GB Standard for the Voluntary CQC Mark Certification V-belts for motorcycles will be implemented. The new GB standard GB/T 18860-2015 (“V-belt of motorcycle transmission“) replaces the old version from 2002.

The new GB standard was announced in October of 2015 and will be implemented soon, no details about the changes have been published yet. As soon as further information is announced by the Chinese authorities, we will let you know about it in our News-page section.

This CQC Mark Certification is a voluntary product certification and conducted by the official certification authority CQC (China Quality Certification Center). The CQC is sanctioned by the governmental agency CCIC (China Certification & Inspection Group) to manage the mandated process for manufacturers to get their CCC certification.

The CQC is the largest professional certification body in the People’s Republic of China. The CQC offers a special Voluntary CQC Mark Certification for a wide range of over 500 products that do not fall into the compulsory certification catalogue.

The CQC regularly publishes new announcements about products that require CCC certification as well as products that can be certified with a Voluntary CQC Mark Certification. It is the responsibility of the exporter and/or manufacturer to carefully check every product and to fully understand the applicable regulations prior to shipping. Each product category of the Voluntary CQC Mark Certification has its own Certification Rules, which are based on the National GB Standards. The Certification Rules have a corresponding Implementation Rule which the product must comply with in order to get a Voluntary CQC Mark Certification. The Implementation Rules can be found on the official website of the CQC. New Voluntary CQC Mark Certification products and product categories are posted on the website frequently along with important information regarding certification application start dates.

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. Call us directly (UK: +44 2071931135, Rest of Europe: +49-69-2713769150, US: +1 773 654-2673) or send us an email.

 

CQC: New GB Standards for the Voluntary CQC Mark Certification of Tyre Valves

Starting January 1, 2017 three new GB Standards for the Voluntary CQC Mark Certification of tyre valves will be implemented:

• “GB/T 1796.1-2016 Tyre valves – Part 1: Clamp in valves“, e.g. for motorcycles (replaces GB 1796.1-2008)
• “GB/T 1796.2-2016 Tyre valves – Part 2: Rubber base valves“, e.g. for industrial vehicles and farming machines (replaces GB 1796.2-2008)
• “GB/T 1796.5-2016 Tyre valves – Part 5: Large core cavity valves”, e.g. for heavy dump trucks, loaders, excavators, scrapers, rollers and graders and other large construction machinery with pneumatic tire valves (replaces GB/T 1796.5-2009).

The CQC Mark demonstrates the conformity of the product with the Chinese standards in regards to quality, safety, environmental and energy efficiencies.

The CQC Mark Certification improves the perceived product quality within the Chinese market, giving a competitive advantage over products that are not CQC certified, thus facilitating the access of foreign products. National quality certifications like the CQC certification are perceived in China to be better in comparison to the UL, CE or ECE markings. For many product groups the CQC Mark Certification has set the standard by which product selections are made by the Chinese consumers. Another advantage is that products marked with the Voluntary CQC Mark Certification have a greatly reduced risk of being detained by Chinese customs.

The CQC regularly publishes new announcements about products that require CCC certification as well as products that can be certified with a Voluntary CQC Mark Certification. It is the responsibility of the exporter and/or manufacturer to carefully check every product and to fully understand the applicable regulations prior to shipping. Each product category of the Voluntary CQC Mark Certification has its own Certification Rules, which are based on the National GB Standards. The Certification Rules have a corresponding Implementation Rule which the product must comply with in order to get a Voluntary CQC Mark Certification. The Implementation Rules can be found on the official website of the CQC. New Voluntary CQC Mark Certification products and product categories are posted on the website frequently along with important information regarding certification application start dates.

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. Call us directly (UK: +44 2071931135, Rest of Europe: +49-69-2713769150, US: +1 773 654-2673) or send us an email.

 

CQC: New GB Standard for the Voluntary CQC Mark Certification of Communication Protocols Between Off-Board Conductive Charger and Battery Management System for Electric Vehicle

In addition to the new GB standards for the Voluntary CQC Mark Certification of “Conductive Charging Systems for Electric Vehicles” (GB/T18487-2015) and “Connection Sets of Conductive Charging for Electric Vehicles” (GB/T 20234-2015) 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) also issued a new version of the GB standard for the Voluntary CQC Mark Certification of “communication protocols between off-board conductive charger and battery management system for electric vehicle” (GB/T 27930-2015). This new version was implemented on January 1, 2016 and replaces the old version of 2011.

The main technical changes that were added are as follows:

• 50 kbit/s communication rate may be adopted as agreement between power equipment manufacturer and electric vehicle manufacturer in the bad communication environment (e.g. commercial vehicle charging station with longer communication distance).
• Reasons for BMS`s suspending charging failure are added.
• Charging sequence flow chart.
• Failure process modes in charging
• Start and suspension conditions for message transmission.

Since this 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 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: Beijing Motor Show 2016

The Beijing Motor Show was held in China from April 25 to May 4, 2016. The show is known as one of the leading motor shows worldwide and takes place every other year.

The organizers were expecting about 80,000 attendees from all over the world for the 2016 show. Among many “commonly known” exhibits, the visitors could witness some surprises as well. The Beijing Motor Show, also known as “Auto China,” is an excellent opportunity to learn about all of the new features from all of the major manufacturers, and to be introduced to new products from smaller manufactures as well. The major Chinese automotive companies are represented alongside the European and US manufacturers at the show as well. Most of them are largely unknown to European customers.

Exhibitors from 14 countries revealed their new models at the show. This year’s trend clearly points towards SUVs, specifically towards smaller SUVs. Besides the traditional combustion engine systems, new and innovative electric and hybrid drives systems were presented at the Beijing Motor Show.

Aside from the standard new models produced by the major car brands, attendees were also treated to some surprises. One great example being the electro-hydraulic valve system which could prove to be a technological revolution. It was developed by the Swedish sports car manufacturer Koenigsegg. The system replaces the conventional camshaft, timing belt and throttle valve in an internal combustion engine. In cooperation with the young Chinese automotive manufacturer Quoros, Koenigsegg plans to introduce this system to the market in the coming years.

In general, China continues to be an attractive market for the automotive industry. An increase in sales within the range from 6% to 10% is expected for the world’s largest market in 2016. For SUVs, luxury, and long version vehicles experts predicts an increase of 15%.
Despite of the recent predictions of a slowed economy, German manufacturers are expecting rising sales of both standard automotive to premium automotive markets. Audi sees great potential in the Chinese market where premium vehicles only make up about 9%, while premium cars make up about 20% in Germany.
Like European manufacturers, Chinese automotive manufacturers are obligated to get the relevant components CCC certified if they are to be sold in China.

In order to get an overview on what CCC certification is, please refer to our website. There you can also find more information on the certification process as well as the associated costs. If you are interested, you can download our free booklet “CCC mad easy” here. To get a copy of our English book “A Brief Guide to CCC: China Compulsory Certification“, please order here at Amazon.
MPR China Corporation is the only non-Chinese company that has been awarded for excellent cooperation with the CCAP.
If you have any questions or if you are looking for an in-depth consultancy, please send us a Email or call us directly (UK: +44 2071931135, Rest of Europe: +49-69-2713769150, US: +1 773 654-2673).

 

CQC: New GB-Standard for Voluntary CQC Mark Certification of Connection Set for Conductive Charging of Electric Vehicles

As previously announced, 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” in their announcement No. 40 from December 28, 2015. It was implemented on January 1, 2016.

At the same time the Chinese authorities also announced a new GB standard for the Voluntary CQC Mark Certification for the connection set for conductive charging of electric vehicles, which was also implemented on January 1, 2016.

This new GB standard consists of GB/T 20234.1-2015, GB/T 20234.2-2015 and GB/T 20234.3-2015, which are replacing the old versions from 2011.

The main technical changes are as follows:

GB/T 20234.1-2015 “Connection set of conductive charging for electric vehicles – Part 1: General requirements”:

• Added 1000V (DC) in rated working voltage (preferred value) as well as 10A (AC), 80A (DC) and 200A (DC) in rated working current (preferred value).
• Deleted the requirement that connection set for charging of which the rated working current exceeds 16A (not including 16 A) shall be equipped with control pilot circuit.
• Modified the protection requirements of power interface and vehicle interface.
• Made clear that electronic locking device shall be installed on vehicle plug of DC charging interface.
• Modification of some test parameters of test methods.

GB/T 20234.2-2015 “Connection set for conductive charging of electric vehicles – Part 2: AC charging coupler”:

• Increased the requirement that the rated current shall not exceed 63A, from 32A before.
• 10A and 63A were added among the rated current values of charging coupler.
• The function of spare contact was extended to three-phase charging function.
• R4 resistance was added.
• The content of control pilot circuit and control principle was deleted.
• The spatial size requirements of plug were modified and adjusted as a normative appendix.

GB/T 20234.3-2015 “Connection set for conductive charging of electric vehicles – Part 3: DC charging coupler”:

• 80A and 200A were added among the rated current values of charging coupler.
• The coupling order of contacts in the charging connection process was adjusted, and electronic locking device was added in the schematic diagram for connection interface.
• Some dimensions of control pilot contact and mechanical lock of charging coupler were modified.
• The spatial size requirements of plug were modified and adjusted as a normative appendix.

Since this 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 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).