FAQs
Q1：What is the definition of medical device in China？
A："Medical devices" refer to: 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; the use of which is to achieve the following intended objectives:
1. Diagnosis, prevention, monitoring, treatment or alleviation of disease;
2. Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap conditions;
3. Investigation, replacement or modification for anatomy or a physiological process;
4. Control of conception.
Q2：Is it record keeping system for medical device in China？
A：No, not yet. Medical device need to be approved by State Food and Drug Administration, P. R .China.
Q3： Does medical device implement classified management？
A：Yes, China implements classified registration and administration of medical devices.
Class I Medical Devices are those for which safety and effectiveness can be ensured through routine administration;
Class II Medical Devices are those for which further control is required to ensure their safety and effectiveness
Class III Medical Devices are those which are implanted into the human body, or used for life support or sustenance, or pose potential risk to the human body and thus must be strictly controlled in respect to safety and effectiveness.
Q4：What are the requirements of import medical device applicant?
A：The foreign applicant should be a legal medical device manufacturer in foreign countries. The imported medical device registration of foreign applicants should be conducted by its representative office in China or the agency in China who is entrusted by the foreign manufacturer.
Q5：How long for the import medical device approval certificate valid?
A： Medical device License is valid for 4 years. If the valid period of medical device license expires and needs to be extended, the applicant should apply for re-registration 6 months before the valid period expires.
Q6：what is the procedure of import medical device registration？
A：①registration test——② clinical trial(if needed)——③ registration submission ——④ registration review（submit supplementary documents if needed）——⑤registration approval （Get approval certificate for import medical device）
Q7：Which departments are needed for import medical device registration approval?
A：Registration testing institutes approved by SFDA, clinical trial sites, SFDA administrative service center, Medical device evaluation center, State Food and Drug Administration medical device Division.
Q8：How long will it take to registration import medical device?
A：It takes 1~2 years depend on different products of different categories.
Q9：How much do the registration test fee and clinical trial fee cost?
A： The price of registration test is based on different testing institutes and test items, while the price of clinical trial fee is related with different clinical trial sites and experiment project as well as the number of cases.
Requirements on Application Documents for the Registration of Foreign Medical Devices
