CFDA: CFDA Issues Working Procedures for the Audit of Quality Management Systems for the Registration of Medical Devices

Certain medical products and devices are required to have CFDA registration 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 imported, bought, sold, used or traded in China. In an effort to insure safety and effectiveness of medical products, there have been numerous changes and revisions within the Chinese regulatory framework of the CFDA registration.

Recently the CFDA issued Working Procedures for the Audit of Quality Management Systems for the registration of Medical Devices in the “Domestic Class III” sector. The Working Procedures stipulate the work linkage between the CFDA technical evaluation institutions and provincial regulatory departments. They also set the formal framework of the auditing system including the required audit documents, the audit timeline, the audit results, and the relation between audit results and product registration evaluation.

In an effort to control and increase the safety of medical devices in China, there have been many regulatory restructuring and revisions of the regulations in recent years. It is important that manufacturers stay up to date with the current regulations. Some of the more recent published updates are as follows:

• March 2014 – The CFDA published a completely new version of their “Regulations for the Supervision and Administration of Medical Devices” (Chinese: 医疗器械 监督管理条例(修订草案)
• July 2014 – The CFDA launched “120 new industry standards for medical devices” (abbreviated as “YY-Standard”).
• 2015 – The CFDA introduced another 90 industry standards (you can find more information on these in our news section).
The purpose for these changes is to promote the positive development of China’s medical equipment industry and to ensure the quality and safety of medical products. 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 regarding official announcements and changes to the regulations.

Please do not hesitate to call or email with any questions you may have.

 

CFDA: CFDA Issues Rules for Classification of Medical Devices

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 imported, bought, sold, traded or used in China. In an effort to insure continued safety and effectiveness of medical products there have been ongoing changes and revisions within the Chinese regulatory framework for CFDA certification.

The CFDA recently issued the Rules for Classification of Medical Devices (Order No. 15), which will be implemented as of January 1, 2016.

The new order discusses how risk-based classification of medical devices will be used not only for registration but also for device production and supervision. This includes revisions and clarifications to classifications, terms, and definitions of medical products and devices.

It can be difficult for medical device manufacturers to determine if their products will require certification, and if so, in which classification their products should be categorized.

A complete evaluation of CFDA-responsibility and classification simplifies your registration process and prevents additional, unplanned costs.

If you have any questions or concerns, please do not hesitate to Email or call us: Germany: +49 69 271 3769 150, UK: +44 2071931135, US: +1 773 654 2673

 

CCC: CCC Certification for Child Safety Seats Mandatory After September 1, 2015

As we previously stated in our news section (CCC: Expiration of Deadlines for Updating CCC Certificates) CCC Certification for child safety seats in motor vehicles will be mandatory starting September 1, 2015. All forms of child restraint systems and child seats including integrated child seats used in the automobile will be required to have CCC certification.

All child restraint systems will be required to have a valid CCC certificate and a CCC mark starting September 1, 2015. Manufacturers of child seats who did not start the China CCC certification process for their products yet, will not meet the Deadline. The CCC certification process is extensive requiring submittal of a complex application, supporting documentation, product testing in China, and a factory audit where the seats are manufactured. The whole process takes several months to complete.
In joint announcement No. 6 of 2014 by AQSIQ and CNCA the previously voluntary CQC certification for Child Restraint Systems (CQC11-491287-2013) became mandatory September 1, 2014. The safety tests are performed as required by GB Standard 27887-2011 “Restraining devices for child occupants of power-driven vehicles” which was implemented on July 1, 2012. After September 1, 2015 child seats, child restraint systems and integrated child seats must have a valid CCC certification in accordance with the prescribed standards, which are issued by the CQC (China Quality Certification Centre) or the CCAP (China Certification Centre for Automotive Products).

More information regarding the CCC certification process for Child Restraint Systems can be found in the corresponding implementation rule, which was issued in May of 2014 and has been in effect since September 1, 2014.

Are you the manufacturer of child safety seats and need a CCC certification for your products? Are you interested in learning more about the new Implementation Rules? Please call us, to get a copy of our presentation with more details regarding CCC for child safety seats.

Please call or email us for more information or to answer any questions you may have (UK: +44 2071931135, Rest of Europe: +49 69 2713769150, US: +1 773-654-2673).

General information regarding CCC certification, the certification process and the costs of associated with certification can be found on our website. For more comprehensive 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: CNCA Publishes Allocation Table for HS-Code and Marking of Products

The Chinese CNCA (Certification and Accreditation Administration, in Chinese: 中国国家认证认可监督管理委员会) recently published an allocation table which consists of HS-Codes and product descriptions.

The purpose is to simplify international trade and to ease the national administration’s control. The released register only refers to the mandatory product certification, which is already published by the CNCA.

Customs tariff numbers (“HS Codes”, also known as “Harmonized System”) are used to categorize products for the customs clearance process.

The list only contains HS codes for products requiring a China Compulsory Certificate (also knowns as “CCC” or “3C” certification). By checking the list, you can get a first impression of whether a certain product need a CCC certificate or if a certain HS code indicates that CCC is mandatory. The list does not replace the official CCC product catalogue provided by the CQC (China Quality Certification Centre, in Chinese: 中国质量认证中心).
It is also important to check the product based on technical specifications and description of use. The HS Codes are independent from the CCC product catalogue, and are not simultaneously updated, therefore it is not enough to only check the HS Code list.

Manufacturers must also check whether there is an existing Chinese GB Standard (GB stands for “Guobiao”, the Chinese word for “National Standard”) for their product that requires a CCC certification. If a GB Standard exists CCC is mandatory and the product will need to be certified according to the corresponding Implementation Rules.

Are you unsure if your products require a CCC certificate?

If so, please call or email us anytime. We can be reached by phone (UK: +44 2071931135, Rest of Europe: +49 69 2713769150, 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.

 

CFDA: The CFDA Issues an Announcement regarding the Filing of Records for Clinical Trials of Medical Products and Devices

Certain medical products and devices are required to have registration of medical devices approval by the China Food and Drug Administration (CFDA, Chinese: 国 家 食 品 药 品 监 督 管 理 总 局 ) before they can be imported, bought, sold, used or traded in China. There have been many changes and revisions within the Chinese regulatory framework of the CFDA regulations in an effort to ensure the safety and effectiveness of medical products for the Chinese market.

The CFDA issued an announcement regarding the filing of records for clinical trials of medical products and devices. The goal is to standardize the record filing of clinical trials and to improve the supervision and management of medical device clinical trials.

The CFDA recently issued the Measures for Unannounced Inspection of Drugs and Medical Devices, which will take effect on September 1, 2015. The measures provide that development, production, operation and the processing of drugs and medical devices are included in the scope of unannounced inspections. The goal of these inspections is to make sure that that manufacturers stay up to date with the current regulations and to support the positive development of China’s medical equipment industry, guaranteeing the quality and safety of medical products. It is expected that there will be more announcements, reforms and updates to the CFDA regulations in future.

In our News section on our website, we will keep you informed regarding the official announcements and changes to these regulations.

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.

 

“National Stage V Emission Standard” Required for Heavy Duty Vehicles in Beijing

High concentrations of toxins in the air have become a well-known problem for China in recent years. The implementation of tighter emission standards and the introduction of regulations to set fuel consumption restrictions pose major challenges for vehicle manufacturers. The current vehicle emission control regulations for vehicles registered in Shanghai and Beijing are already very strict, however the Chinese government has plans for even stricter controls to be introduced in the coming years.

Starting June 1, 2015 all diesel engine trucks will be required to meet the “National Stage V Emission Standard” The future standard will mandate that all diesel trucks with a maximum compound of 3.5t will have to comply with the Chinese government’s emission standard. The regulation will affect about 220,000 trucks (or about 4% of all vehicles) in Beijing City. Although a relatively small percentage, trucks in Beijing are responsible for 50% of NOx emissions and for 90% of PM emissions. Starting June 1, 2015, only diesel trucks with a diesel particulate filter such as busses, fire brigade vehicles, cleaning vehicles, post vehicles, shuttle busses, school busses etc. are allowed to be used in Beijing city.
Are you looking for more information regarding new Chinese standards such as the CCC Certification or GB Standard? Do you need more information regarding regulatory updates? 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.

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.

 

CFDA: CFDA Issues Measures for Unannounced Inspection of Drugs and Medical Devices

Certain medical products and devices are required to have CFDA registration 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 imported, bought, sold, used or traded in China. In an effort to insure safety and effectiveness of medical products, there have been numerous changes and revisions within the Chinese regulatory framework of the CFDA registration.

The CFDA has recently issued the Measures for Unannounced Inspection of Drugs and Medical Devices, which will take effect on September 1, 2015. The measures comprises of 35 articles in five chapters, including the general provisions, initiating, inspection, handling and supplementary provisions. The measures provide that development, production, operation and the processing of drugs and medical devices are included in the scope of unannounced inspections.
The goal of these inspections is to make sure that manufacturers stay up to date with the current regulations and to promote the positive development of China’s medical equipment industry, ensuring the quality and safety of medical products.

Some of the more recent published updates are as follows:

• March 2014 – The CFDA published a completely new version of their “Regulations for the Supervision and Administration of Medical Devices” (Chinese: 医疗器械 监督管理条例(修订草案)
• July 2014 – The CFDA launched “120 New Industry Standards for Medical Devices” (abbreviated as “YY-Standard”).
• 2015 – The CFDA introduced another 90 industry standards (you can find more information on these in our news section).

It is expected that there will be more announcements, reforms 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 and changes to these regulations.

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