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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:
- Checking the necessity of certification for products;
- Complete CCC application preparation (including
assistance with form completion, communication with the certification
authority, and handling the necessary payments);
- 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
- 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);
- One day pre-audit
(Working through provided checklists, review of Quality Management
documentation, Support in preparation of control procedures for CCC
- Complete audit escort (travel escort for the
auditors, a professional interpreter (Chinese-English) for the audit and
checking of the inspection report);
- 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);
- Complete organization of follow-up certification, including audit;
- 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
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.
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
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
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“.
||1. Preparation of application documents and submission to the Chinese authorities
||2. Acceptance of application, reception of the CCC Factory code and requirements of the test products
||3. Product testing in a Chinese laboratory
|Parallel to the tests:
|Optional: One day pre-audit
4. Factory Audit
The certification authority sends Chinese auditors to inspect the factory. The audit usually takes two days.
||5. CCC certificate is granted
||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.
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
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