To enable thepublic to obtain safe and effective medical devices, Chinaimplements a marketaccess system for medical devices. Before marketing a medical device in China,the applicant shall apply for approval of filing or registration from relevantregulatory authorities.
The Medicaldevices filing is a process in which the applicant submits the requireddossiers to the medical regulatory authority for filing a medical device.
The Medicaldevices registration is a legal process in which the medical regulatoryauthority conducts a systematic evaluation on the study results of the safetyand effectiveness of a medical device under application to determine whether ornot the medical device can be market. There are three types of registrationinclude initial registration, registration renewal and registration change.
Registrationprocesses
1. Pre-acceptanceConsultation
The applicant can apply for a consultationregarding the technical issues before the acceptance of a medical deviceregistration application.
2. Medical DeviceClassification
Classification ofthe medical device :medical devices can be divided into passive and activemedical devices according to different features; body-contact andnon-body-contact medical devices according to the contact way with human body.For ease of supervision, however, the regulatory authority performsclassification according to the risk level of medical devices. The risk levelof medical devices is comprehensive judged, according to the intended use, thestructure, application methods, application conditions, the contact way withhuman body, etc.. The medical devices classification stated herein mainly refer to the manage categoriesclassification.
With regard to the supervision of medical devices, themajor developed countries around the world also adopt the risk-level-basedclassification.
| America | Europen Union | Japan | China |
Low Risk
High Risk | Class I | LevelI | LevelI | Class I |
Class II | LevelII a | LevelII | Class II |
LevelII b | LevelIII |
Class III | LevelIII | LevelIV | Class III |
3. Test
Medical device test refers to the process in which themedical device, in the stages such as manufacturing, experiment, scientificresearch, usage and maintenance, is tested or measured real-time ornon-real-time for purpose of timely access to the information on object undertest and control with a report be issued. Throughout the use, medical devicespreferably exert full play to superiority only when they are continually testedand assessed to ensure normal work, thus daily monitoring of medical devices isof indispensability.
In China, according to relevantstipulations of provision for Medical Device Registration or Provisions forIn-vitro Diagnostic Reagent Registration, the Classes II and III medicaldevices shall be first approved and granted with registration certificates bythe relevant food and drug administrations, before they come to market.According to the current regulations, the medical devices test is a fullperformance test, also known as type test. Class II and III medical devices shouldbe tested by the test facilities accredited by NMPA, and clinical trials orapplication for registration can only be implemented after the products aredetermined to be conformed to the product technical requirements by data orconclusion via clinical trials and qualified.
4. ClinicalEvaluation
Medical deviceclinical evaluation refers to the process in which the applicant registrantvalidates whether the products meet use requirements or scope of applicationthrough information such as clinical literature, clinical experience data andclinical trials. Requirements for clinical evaluation data may be differentfueled by varied application scope of medical device leading to various risksthroughout the use. The Class III medical devices of higher risk shall beapproved by the Medical Administration. Department under the State Councilprior to clinical trials.
Upon applicationfor Class II and III medical devices, clinical evaluation data may be collectedthrough multiple means such as clinical trials. Referto Technical Guidance onClinical Evaluation of Medical Devices for details. Theclinicalperformance andsafety data collected throughout the clinical evaluation and all kinds of datashall be included in clinical statistical analysis, so as to get acomprehensive and objective clinical evaluation.
5. InnovativeProduct Review
On February 7, 2014, CFDA issued Special Review andApproval Procedure for Innovative Medical Devices (interim), which wasimplemented from March 1, 2014. This Procedure is a review and approvalapproach set for innovative medical device(IMD) on the premise of ensuring thesafety and effectiveness of listed products. On Nov.2, 2018, Special ReviewProcedure for Innovative Medical Devices was issued and implemented on December1.
6. PriorityReviewandApproval Processes
The National Medical Products Administration implements the priorityreview and approval policy for registration of domestic medical devices ofClass III and imported medical devices of Class II and III which meet one ofthe following conditions.
1. The medicaldevices for diagnosis or treatment of rare disease and with obvious clinicaladvantages;
2. Themedical devices for diagnosis or treatment of malignant tumors and with obviousclinical advantages;
3. Themedical devices for diagnosis or treatment of diseases which are endemic to andprevalent in the elderly and against which the existent diagnosis or treatment approacheshave been ineffective;
4. Themedical devices specific to children and with obvious clinical advantages;
5. Themedical devices which are in urgent clinical need and there is no similarproduct available in China.
