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XINLUN2015

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5 DERNIERS ARTICLES
- CNCA Published a New HS Codes list of CCC Mandatory products
- CNCA sets new goals at the 10th World Accreditation Day
- New GB Standard for License Plate Lightning
- Neue Regularien im Bereich CCCF-Zertifizierung für Feuerwehrfahrzeuge
- Article about CCC-Certification for Automobiles and Automotive parts published in In-Compliance Magazine
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 Our CCC Certification Package Alerter l'administrateur Recommander à un ami Lien de l'article 

The shortest route to CCC certification is China Certification’s all-inclusive package. We understand that CCC can be a complex hurdle for manufacturers and therefore, we competently cater to their needs at every level by providing the following services:

  1. Checking the necessity of certification for products;
  2. Complete CCC application preparation (including assistance with form completion, communication with the certification authority, and handling the necessary payments);
  3. Complete handling of the product testing (completion of the customs clearance, document exchange, handling of payments, communication with Chinese test labs and evaluation of test reports);
  4. Complete audit preparation (application, coordination and communication with the certification authority, document exchange, handling of payments, organization of inspection and travel program, as well as providing the required documents, information and checklists for the audit preparation);
  5. One day pre-audit (Working through provided checklists, review of Quality Management documentation, Support in preparation of control procedures for CCC certification);
  6. Complete audit escort (travel escort for the auditors, a professional interpreter (Chinese-English) for the audit and checking of the inspection report);
  7. Complete preparation for obtaining your CCC printing permission (advice on marking best practices, application for printing permission and templates for product labeling with the CCC logo and factory code);
  8. Complete organization of follow-up certification, including audit;
  9. And prolongation of the permission of printing.

If needed, we can also provide pre-audits to ensure a positive outcome of the CCC audit. We also assist our clients with revising their quality management documents as well as any other documented procedures related to certification.

China Certification maintains excellent long-standing relationships with key personnel in the certification centers and test labs in China. With subsidiaries in Beijing and Shanghai, we maintain a presence in China, which allows us to offer optimal service for all CCC applicants. We combine Western and Chinese strengths in our international management team, providing a multi-cultural understanding that shows in our work with clients, partners and certification authorities.

Since 2005, we have supported numerous automotive supplies with their CCC certification and currently handle certification for over 100 factories, overseeing follow-up audits, certification management and change management.

Join the many industry leaders we count among our clients and take advantage of our speed and accuracy to obtain your CCC with minimal hassle and first class service. If you have any questions or would like to know how we can serve you, please send us an email.

  Aucun commentaire | Ecrire un nouveau commentaire Posté le 09-04-2015 à 15h46

 CFDA Classification Alerter l'administrateur Recommander à un ami Lien de l'article 

According to the Regulations for the Supervision and Administration of Medical Devices, Medical Devices are defined as (Guideline 93/ 42/ EWG, Article 1, Paragraph 2, Iss. 2007):

Any instrument, apparatus, appliance, material, or other article, whether used alone or in combination, including the software necessary for its proper application. It does not achieve its principal action in or on the human body by means of pharmacology, immunology or metabolism, but which may be assisted in its function by such means […].

Medical devices for the Chinese market are classified into three different categories by CFDA. The three classifications are categorized as Class I, Class II, and Class III. For each class, specific administrative procedures, product tests and/or even clinical trials may be required for the approval process.

  • For Class I devices, safety and effectiveness can typically be ensured through documentation, so product tests and clinical trials in China are usually not required.
  • For Class II devices, safety and effectiveness can be ensured through documentation and product testing. Some Class II devices may require clinical trials.
  • Class III devices which are usually implanted into the human body or are used for life support or sustenance, can pose a potential risk to the human body and are strictly controlled by mandated tests and clinical trials to ensure their safety and effectiveness.

 

It can be difficult for medical device manufacturers to determine whether their products require certification and in which class their products should be categorized. In our CFDA-Booklet you can find more information about the three different classifications.

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

  Aucun commentaire | Ecrire un nouveau commentaire Posté le 19-03-2015 à 07h47

 CCC Certification Process Alerter l'administrateur Recommander à un ami Lien de l'article 

The following table provides a brief overview of the CCC certification process. For a more detailed description of each step, please read our free information booklet “CCC Made Easy“.

Timeline* Step
Week 1-2 1. Preparation of application documents and submission to the Chinese authorities
Week 3-4 2. Acceptance of application, reception of the CCC Factory code and requirements of the test products
Week 5-10 3. Product testing in a Chinese laboratory
Parallel to the tests: 

Week 4-14

Optional: One day pre-audit
4. Factory Audit
The certification authority sends Chinese auditors to inspect the factory. The audit usually takes two days.
Week 15 5. CCC certificate is granted
Week 16 6. CCC-mark printing permission is granted 

After approval by the certification organization CNCA, the product must be labeled with the CCC logo.

* = The duration of the certification depends on the capacity of the authority, the laboratory and the auditors. Thorough planning ensures that the target duration will not be exceeded.

The 3C certificate and subsequent permission of printing for the CCC mark must be renewed annually as part of a follow-up certification, which includes a factory audit.

The proceedings of the follow-up certification are comparable with those of the initial certification, but overall much shorter, simpler and less costly. Typically, no additional product testing in China is required and the audit will usually take only one day. Five years after the initial CCC certificate was issued, the follow-up audit will usually take two days and tests in China will be requested.

The success of the certification depends on diligently following Chinese regulations. The results of product testing and factory inspection are checked by Chinese authorities and will be accurately compared with previously submitted forms. In the case of errors or faults, the certification may be denied or delayed.

In the case of a certification being denied, a report will be issued offering the reasons for the rejection. Re-applying is possible but will involve additional costs and time.

A CCC consultation and advisory service, such as China Certification, increases your chances of successful certification and saves time, money and unpleasant surprises.

  Aucun commentaire | Ecrire un nouveau commentaire Posté le 28-02-2015 à 13h15

 What is CCC Alerter l'administrateur Recommander à un ami Lien de l'article 

China Compulsory Certification (CCC) is similar to other certifications for product quality standardization–such as the European CE system–but there are important differences. The CCC  certificate was introduced in 2002 and applies to imported goods as well as to Chinese products. Products which require certification may only be imported, sold and/or used in business activities in China, after a China Compulsory Certification has been obtained.

Failure to comply with CCC regulations will lead to imported goods being detained at the border or returned to the sender. Likewise, improper use of CCC licenses or printing a CCC-mark on products without certification will also result in fines and penalties. Even if a product does not need China Compulsory Certification, problems may still arise if a customs officer demands a CCC certificate. For this reason, Clearance Certificates are recommended in order to significantly reduce the risk of import-related problems.

The CCC replaced the certifications of the “China Import and Export Commodity Inspection Bureau (CCIB)” and the “China Commission for Conformity Certification of Electrical Equipment (CCEE)” thereby significantly simplifying foreign trade with China and creating a “level playing field” for all market participants. However, special certificates for medical products (SFDA) and telecommunication equipment remain in place.

The two most important elements of China Compulsory Certification(CCC) certification are product testing (products that are to be certified are sent to test laboratories in China) and factory audits (inspection of the product manufacturers by Chinese auditors). Once a certification is granted, it is valid for several years but must be maintained through annual follow-up audits.

The CCC certification process also includes comprehensive application documents, factory preparation and various payments and fees. Through the aid of a company like China Certification, the entire process can be completed within 4-5 months; without support, the process typically requires 6-18 months.

Manufacturers of products with a CCC obligation are required to apply for the CCC Certification with the responsible certification authority. These are the most important Chinese certification authorities:

 

 

For more China CCC information, please read our free information booklet CCC Made Easy, which contains a special focus on certification for automotive suppliers.

You will also find useful information on our Frequently Asked Questions (FAQ) page or in the list of products subject to certification. If your product does not require CCC, China Certification can also assist you with clearance certificates.

  Aucun commentaire | Ecrire un nouveau commentaire Posté le 11-02-2015 à 08h33


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  Blog créé le 11-02-2015 à 08h31 | Mis à jour le 11-08-2017 à 11h49 | Note : Pas de note