CFDA Certification and Registration
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 are classified into three different categories by CFDA. The three classifications are marked as Class I, Class II, and Class III. For each category specific administrative procedures, product tests and/or even clinical trials may be required.
For Class I devices, safety and effectiveness can be ensured through routine administration, so product tests and clinical trials in China are usually not required.
For Class II devices, safety and effectiveness can be ensured through routine administration and product testing. Some devices require clinical testing as well to seek authorization for Chinese market.
Class III devices which are implanted into the human body or are used for life support or sustenance pose potential risk to the human body and are strictly controlled by mandated tests and clinical trials to ensure safety and effectiveness.
It can be difficult for medical device manufacturers to ascertain whether their products require certification and in which class their products should be classified.
CFDA Process of Classification and Registration of Medical Devices
The application and all relevant documents are prepared and the applicant must determine the classification (Class I, II or III) of their medical device at this time.
The completed application documents with relevant paperwork are submitted to the CFDA who will either confirm the classification or reassigns it appropriately.
The device is tested, at which stage further legal and technical documentation may be required.
Clinical trials are performed if necessary.
Evaluation is conducted by the CFDA and a technical and administrative review is given.
The device is approved and a certificatate of registration and licensing is issued.
STIN CFDA Registration Services
The certification and registration of medical products with the CFDA can be an extensive and drawn-out process. A large number of documents, specifications and reports must be provided and intensive on-going communication with the certification bodies and testing laboratories is needed.
Conducting the registration from overseas can be more difficult due to communication problems and the changes that may arise regarding the requirements of the regulatory bodies. By authorizing China Certification Corporation to register your device your CFDA certification will be managed professionally and smoothly.
What we can do for you:
China Certification Corporation will assess which documents are needed and prepare all application documents for the device(s) and translate them into Chinese as required by the CFDA.
We handle all of the fees and direct communication with the Chinese authorities from our offices in China.
We submit the application with related documents and advise the classification of the medical device into Class I, II or III.
We advise you on all of the necessary steps in preparation for product testing.
We keep you informed of the progress with regular updates.
We arrange for the proper clearance of your test products in China and pay the import taxes and customs duties.
We handle product testing for you, including the payment of test fees, document exchanges, communication with the laboratory and evaluation of the Chinese test reports.
We obtain the Chinese CFDA certificate for your products for you.
Please note that only after handing in all application documents the CFDA decides whether a medical device registration is possible or not (usually within 30-60 days after application). There is the possibility that the application is rejected by CFDA. If rejected, an explanation and statement will be provided to the applicant. Consequently, before official application, neither a categorization nor acceptance for registration can be given with 100% certainty.
In China, all imported medical devices cannot be sold until the applicant pass CFDA approval and get the registration certificate. Here are the steps for CFDA Approval for medical device.
The first step for CFDA approval is to determine classification of your medical device in China using the China Food and Drug Administration (CFDA) Order No. 15 and other CFDA documents. There are three classes of devices: I, II and III.
The next step is to appoint a Legal Agent and After Sales Agent located in China who will coordinate and control your medical device registrations for CFDA approval.
The third step for CFDA approval is to pay attention to demonstrate proof of home country approval using a Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG). For Foreign manufacturers, they have to submit a notarized quality system certificate such as ISO 13485 or proof of US FDA QSR compliance.
For Class II and III devices, submit your device to the CFDA for testing. Testing is carried out by a CFDA authorized laboratory. Clinical trials conducted in China may be required for some devices, including high-risk and implantable devices.
And then, what do you have to know for CFDA approval For Class III and IV medical devices, prepare Chinese Registration Standard dossier, including testing results, and submit to CFDA for approval.
At last, you have to do for CFDA approval is to prepare application for an Import Medical Device Registration Certificate (IMDRC) and submit it for CFDA approval. Class II and III submissions will also include the Registration Standard dossier.
After you finish the above steps, CFDA will issue IMDRC following application review. Your IMDRC certificate is valid for 4 years. Place CFDA registration number on your device label, packaging material and user manual. You are now approved to sell your device in China.
More information regarding CFDA, please have a look at their website: www.sfda.gov.cn
