1. Medical equipment compulsory standard
According to the relevant provisions of the Standardization Law of the People's Republic of China，Technical requirements that need to be unified nationwide，National standards should be formulated; there is no national standard but also need to be unified in the scope of a certain industry in the country，You can formulate industry standards。Guarantee human health，personal、Standards and laws of property security、Administrative regulations stipulate that the standard for compulsory execution is compulsory standards，stake betting appOther standards are recommended standards。Mandatory standards must be executed。

Article 6 of the "Regulations on the Supervision and Administration of Medical Device"，Medical device products should meet the mandatory national standards of medical equipment; there is no mandatory national standard，It should comply with the standard of compulsory industry industry for medical device。and in terms of registration management，Clearly stipulate that "the mandatory standards for medical device have been revised，Application for the continuation of the registered medical device cannot meet new requirements "will not continue registration。

Medical Devices forced national standards can be query on the website of the National Standardization Management Committee (www.sac.gov.cn)。Medical Device Mandatory Industry Standards can be query on the "Medical Device Mandatory Industry Standard" column query,or at the "Www.nicpbp.org.cn) standard and supplementary inspection method at the" Equipment Mandatory Industry Standard "column query at the website of the State Food and Drug Administration。

2. Recommended standards for medical devices
According to the relevant provisions of the Standardization Law of the People's Republic of China，Encourage enterprises to adopt recommended standards。If there are other scientific basis for the company to prove the safety and effectiveness of medical stake betting appequipment，You can also use other methods。Enterprises can directly adopt recommendation standards in the technical requirements of medical device products，You can also prove through other methods to prove that the product meets the safety and effective requirements。If the enterprise quotes the performance indicators and inspection methods of the recommended standard in the product technical requirements，That is, the enterprise uses the recommendation standard as the technical requirements promised by the company，The medical devices listed on the market must meet the requirements of product technical requirements and the requirements for referenced recommendation。

3. Principles of the Guidance Principles of Medical Device Technology
In order to strengthen the supervision and guidance of the registration of medical device products，Further improve the quality of registration review，The State Administration of Food and Drug Administration organizes the formulation of medical device technology review guidance principles。Guidance principles include scope、Requirements for Registration Reporting、Risk management requirements、Review points、Registration unit division、Clinical evaluation requirements、Manual requirements, etc.。

Guidance principle is the guidance file used My stake betting appby applicants and reviewers，Not involved administrative matters such as registration approval，It is not enforced as a regulations。The applicant shall determine whether the content is applicable according to the specific characteristics of the product，If it is not applicable，Need to explain the reasons and the corresponding scientific basis。If any method can meet the requirements of the regulations，You can also use，But it should provide detailed research materials and verification materials。

The guidance principles released by the Food and Drug Administration can。

4. Regarding the requirements of clinical evaluation data of medical equipment
"Technical Guidance Principles of Medical Device Clinical Evaluation Technical Guidance" for analysis and evaluation requirements obtained by clinical trials or clinical use of the same variety of medical devices，Clear data should be the corresponding data obtained。"Notice of the State Administration of Food and Drug Administration on the Implementation of the Management Measures for the Registration of Medical Device and in vitro Diagnostic Reagents" (Food and Drug Administration [2015] No. 247) No. 6 based on legal data requirements，Make authorization requirements for the non -public data of the same variety of medical devices to be used，To ensure the legality of the data source。Data stake online sports bettingpublished publicly，If the literature published publicly、Data、Information, etc.，No need to obtain authorization。