Contacter l'auteur de ce blog
<< Octobre >>
Ajouter xinlun2015 à vos favoris
The various costs associated with certification will depend on the products.
The certification itself involves:
- Application fee
- Product test fees
- Inspection fees
- Travel costs and related expenses for the auditors
- Fees for the permission of printing of the CNCA
You must also consider the cost of an interpreter, the cost of the
products sent for testing as well as the employee time that it takes to
prepare and handle the certification process, particularly if this is
done without the aid of advisory firm.
When forms are filled out incorrectly, tests and/or audits must be
repeated incurring additional, unnecessarily high costs. Likewise,
improper CCC markings will result in deliveries being detained by
Chinese customs and additional fees may be levied.
Below is an example of the cost of CCC certification
for two vehicle headlights. (Note: the example does not include
consulting fees or the cost of a translator.)
By hiring a professional certification advisory firm,
problems can be avoided from the outset, thereby reducing the risk of
running up additional costs. Furthermore, through the assistance of
certification advisors, the CCC mark is obtained quickly, greatly
reducing opportunity costs incurred by delayed product launches.
Our offers are very transparent, as we list all costs individually. The quoted total price will include all certification fees and related costs.
We also assume all risks associated with exchange rates and authority
fee increases. Our expert interpreters assure smooth communication with
the Chinese auditors during the audits.
Contact us to receive a free calculation of your CCC costs. Simply
provide us with product specifications and the number and locations of
production plants for an accurate quote. If you have any questions,
please send us an email and we’ll be happy to provide additional
If you think that you do not require CCC certification for your products, you will find useful information on our Frequently Asked Questions site (FAQ) or in the list of products subject to CCC certification. If you do not need CCC, China Certification can still assist you with clearance certificates.
Our introduction video gives an overview of the necessary steps involved in getting CCC certification.
China Certification Corporation provides you with an all-inclusive package for your
CCC certification. It includes the provision of all
necessary materials and documents needed for the preparation of your
initial CCC factory inspection. We will send you prepared procedures
that you will need to implement in order to pass the inspection. By
this, we guarantee the best conditions for a successful CCC audit.
Due to time constraints, inexperience or general uncertainties, a pre-audit
may be a reasonable consideration. The pre-audit is conducted by one of
our experienced consultants and follows the same criteria used by the
Chinese auditors. The one day pre-audit will give you an over-view of
any potential risks, allowing your team to resolve them before the
actual audit takes place.
The pre-audit includes:
- Working through provided checklists
- Examining documentation required by the Certification Authority
- Review of Quality Management documentation
- Understanding Chinese regulations
- Mock facility inspection following the Certification Authority protocol
- Support in preparation of control procedures for CCC certification
- Assistance in completing any necessary missing documentation
- Final review and report of the facility preparedness and recommended action of correction if needed
During the pre-audit we will share our extensive knowledge of the CCC
factory audit with you. You can fully benefit from our experience and
take the opportunity completely understand the audit and ask any
questions you may have without any risks. The pre-audit can provide you
with all of the tools necessary to have a confident, relaxed, and
successful final (real) audit.
Our pre-audit service is also available if you have not asked us to accompany your complete CCC certification process.
For a non-binding quote please call us directly (UK: +44 2071931135,
US: +1 773 654-2673, Europe except UK: +49-69-2713769150) or email with any questions you may have.
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.
|<< <<< 1 2 3 | 4 | 5 >>> >>|