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CFDA: New Regulation Published for Quality Management of Medical Devices
An ageing population and improved living standards have created a strong demand for medical devices in China. The safety of those products is ensured by the China Food and Drug Administration (CFDA, chin: 国家食品药品监督管理总局). At the 16th and 17th minister’s working meeting new and revised regulations governing the good practices in supply and medical device manufacturing were adopted. The new requirements are aimed at improving the quality and safety of related medical products.
The new supply practice went into effect December 12, 2014 and includes 66 articles in 9 chapters. The new requirements are in regards to the quality management of companies producing medical devices. There are more stringent control process covering the purchase, acceptance, storage, sales, transportation and the after-sales service of medical devices.
The revised practice for manufacturing medical devises includes 84 articles in 13 chapters and will go into effect March 1, 2015. The new requirements are aimed at improved quality management at the manufacturing level. These requirements cover personnel, manufacturing facilities, manufacturing equipment, document management, product design and development, procurement, production management, quality control, sales, after-sales service, control of non-conforming products, adverse event monitoring and more.
It is the responsibility of the manufacturer of medical devices to keep up to date with the latest regulations and to maintain compliance. Manufacturers found out of compliance risk fines and/or suspension or revocation of their CFDA registration. To avoid this, it is important to check the revised practices against your current procedures.
As soon as new announcements or information by the CFDA becomes available, we will provide the information in our News-Area. There you can find all relevant information published by other Chinese authorities.
Do you need more information about certifying medical devices through the CFDA? Learn more at our CFDA-Area on our homepage. For more detailed information you can download our “CFDA booklet” free of charge.
If you would like to know more, have questions or concerns, please contact us any time by phone or email .
Article About the Extended AQSIQ-Product Catalogue for Recycling Materials Published in “Der Metallhandel”
In the January/February 2015 edition of the magazine “Der Metallhandel”, published by German metal distributors e.V., the executive director of the MPR China Certification GmbH, Mr. Julian Busch submitted an article about the extended AQSIQ-product catalogue for recycling materials.
This article refers to the announcement made on December 31, 2014 by the Chinese authorities AQSIQ(General Administration of Quality Supervision, Inspection and Quarantine), whereby they extended the product catalog, “Importation of Recycling Products and Waste Materials in the People´s Republic of China,” which regulates the importation of recycling materials. The revised version became effective January 1, 2015.
The catalog was originally issued in 2009 setting the standards for the importation regulations for recycling products and waste materials. In an effort to control and monitor the safety of waste importation the catalog was created as a collaborative effort by the Department of the Environment, the Department of Trade, the Commission for National Development and Reform and the Customs Administration in China.
The Product catalogue regarding the importation regulations for recycling products consists of three parts:
- Prohibited waste materials
- Restricted imported recycling materials
- Allowed imported recycling materials
It is the responsibility of the shipper to carefully check every material they are shipping, and to fully understand the applicable regulations beforehand. Please note that, as an exporter of waste- and recycling materials into China you are obliged to acquire an AQSIQ-registration.
The published article can be read here.
Mr. Julian Busch has already published numerous articles for magazines as well as online platforms regarding entry into the Chinese market and the requirements to enter the Chinese market. A summary of all his publications is available here.
Are you looking to export raw waste materials into China (such as recycling materials, waste paper, scrap metal)? If so, you will need an AQSIQ license.
We will be happy to help and advise you on how to get your AQSIQ registration! Getting the AQSIQ license is a complex process, which requires thorough preparation. Complete and careful attention to the application, and preparation of the supporting documentation is crucial for a successful registration.
Please contact us for your individual non-binding offer, or if you are just interested and want to know more about AQSIQ-registration Tel.: +49-69-2713769150 or by email.
New GB Standard for Lithium Ion Cells and Batteries Published
On December 05, 2014 the Chinese certification authority CQC (China Quality Certification Centre, chin. „中国质量认证中心“) published a new GB Standard (GB31241-2014) for Lithium ion cells and batteries used in portable electronic equipment, which will be implemented August 01, 2015. Lithium ion cells and batteries were not previously included in the official “CCC Mandatory Product Catalogue”. Manufacturers of lithium ion cells and batteries used in portable electronic equipment will now have the option to apply for a voluntary CQC Mark Certification. The CQC is already accepting applications for the voluntary CQC Mark Certification.
Lithium ion cells and batteries have become an important component in the new generation of portable devices. Safety and storage of these cells and batteries is crucial in overall safety of the complete product. The new GB standard is the first of its kind published by the Chinese certification authorities. Previously products in this category were tested and approved in accordance to the UN regulation UN 38.3 / UN Transportation Test.
Through product testing at accredited test laboratories in China, the CQC will ensure the safety of the lithium ion cells and batteries. Through this voluntary certification manufacturers will have a competitive advantage in their product. The Chinese consumer is becoming more selective in the products they choose and are willing to pay more for quality and safety.
In order to obtain a voluntary CQC Mark Certification products will need to go through tests in over 30 categories. Apart from the usual security requirements (safety parameter, durability, marking etc.), this certification will also require tests in regards to environmental aspects, safety plugs and charging attributes.
Are you a manufacturer of lithium ion cells and batteries for electronic equipment or are you looking for more information regarding new Chinese standards? 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.
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.
New Program to Improve Competition for Luxury Cars in China
In April 2015, the Chinese certification authorities announced a pilot program which will take place within Shanghai’s free trade zone. This program will allow unauthorized dealers to sell imported cars within China. They are calling the program “parallel imports”. Until now, selling imported cars on the Chinese market was limited to official dealers who artificially inflated their prices to be far higher in China than other countries. The purpose of the new program is to promote competition, lower costs and improve the customer’s choices.
According to a lawyer who attended a closed-door seminar this pilot program is a part of a broad anti-monopoly campaign by the Chinese government to improve market conditions and bring down prices of imported cars. One such example of over-inflated pricing would be a BMW 650i xDrive that sells in the United States for approximately $97,900 (USD), would sell in China for about $320,179 (USD) (2,000,000 Yuan) after taxes.
The current situation has caused the establishment of a “grey market” for auto sales. The “grey market” consists of unauthorized dealers selling cars at a reduced price, but buyers have been cautious due to concerns related to warranty and after-sales-service on unauthorized vehicles. One of the most important conditions in the new program is that buyers will now be legally entitled to warranty packages, regardless of whether the imported car came from an authorized or unauthorized dealer channel.
More than 20 dealers have already applied to be registered for the new program, which will allow them to sell luxury cars at a 10-20 percent discount.
In 2014 sales of premium cars rose by more than 20 percent to around 1.6 million vehicles according to consultancy Automotive Foresight (Shanghai) Co Ltd. Although still growing, premium cars only make up about 10 percent of China’s total car sales. The new program may support even stronger growth in the premium automotive segment.
Are you interested in learning more about our CCC certification service? Then call or email us any time: Germany: +49 69 271 3769 150, UK: +44 2071931135, US: +1 773 654 2673.
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.
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