• CCC (China Compulsory Certification)


    Introduction

    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:


    Certification Process

    The following table provides overview of the CCC certification process.

    Timeline Step
    Week 1-2 Preparation of application documents and submission to the Chinese authorities.
    Week 3-4 Acceptance of application, reception of the CCC Factory code and requirements of the test products.
    Week 5-10 Product testing in a Chinese laboratory
    Parallel to the tests:
    Week 4-14
    • Optional: One day pre-audit
    • Factory Audit
    • The certification authority sends Chinese auditors to inspect the factory.
    • The audit usually takes two days.
    Week 15 CCC certificate is granted
    Week 16 CCC-mark printing permission is granted
    After approval by the certification organization CNCA, the product must be labeled with the CCC logo.

    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.

  • CFDA (for Medical Devices)


    Introduction

    In order to enhance efficiency of supervision of medical devices and to secure the safety and health of citizens, CFDA established Regulations on Supervision and Management to Medical device (No. 276, State Council of the People's Republic of China). CFDA approves sales of medical devices either manufactured in China or imported from foreign countries.

    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.

    Classification Quality Management Country of origin approval Product test Clinical Studies Component Authority
    Class I Required Required Rarely necessary Not necessary City level
    Class II Required Required Required Rarely necessary Provincial level
    Class III Required Required Required Required Nation level

    It can be difficult for medical device manufacturers to determine whether their products require certification and in which class their products should be categorized.


    Process of CFDA

    Based on the risk class, different steps in the application process must be taken with different supporting documents being submitted.
    According to the Chinese regulations, re-certification must be done every 5 years.

    CFDA Process of the Classification and Registration of Medical Devices

    • Application documents as well as all relevant supporting documentation must be provided. The manufacturer will need to classify their product into Class I, Class II or Class III, based on risk factors.
    • All application and supporting documentation must be submitted to the CFDA. They will review application, supporting documents and classification and accept, reject or re-classify.
    • The medical device will be tested by a CFDA approved test laboratory in China.
    • Legal and technical supporting documentation may be requested.
    • Clinical trials will be conducted (if required).
    • Evaluation of product test and/or clinical trial is done by the CFDA. Final results will be presented in a technical and administrative report.
    • If the device is approved, a certificate of the registration and license will be issued.

    Please note that only after handing in all application documents will the CFDA decide whether a medical device registration is possible (usually within 30-60 days after application). There is the possibility that the application is rejected by CFDA, if this should happen an explanation and statement will be provided to the applicant.

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