The medical devices regulatory system bases on regulations issued by the State Council, CFDA orders and CFDA documents that provide detailed rules for medical device registration and licensing practice.
The main responsibilities of CFDA are:
- Draft laws, regulations and rules and policy plans on the administration and supervision of food safety, drugs, medical devices and cosmetics
- Formulate the regulations on food administrative licensing and supervise their implementation
- Organize the formulation and publication of the national pharmacopeia, other drug and medical device standards and classification system, and supervise their implementation
- Formulate the investigation and enforcement system for food, drugs, medical devices and cosmetics, and organize their implementation
- Establish food and drug emergency response system in case of food and drug safety incident
- Formulate science and technology development plans for food and drug safety, and organize their implementation
- Undertake the public communication, education and training, and international exchanges and cooperation in the field of food and drug safety
- Guide food and drug administration works of local governments
- Undertake the routine work of the Food Safety Commission of the State Council
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.
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According to the process, the approval (or not) of the CFDA is given within 30-60 days after application. If the application is rejected, an explanation and statement will be provided to the applicant.
The application for such registration can be a drag of its products’ distribution in China. That is why, before beginning this kind of registration, it is necessary to get the advice from experts used to deal with these administrative issues.