Medical device classification|Shenzhen medical device license application conditions and procedures

Medical device classification|Shenzhen Medical Device License Application Conditions and Process Medical Device Classification|Shenzhen medical device license application conditions and procedures Medical device licenses are divided into three categories，One type of medical device license can be applied for directly，Class II medical device license requires filing，Class III medical device licenses need to be reviewed and approved by relevant departments before they can be applied for.。

Medical device license is used to operate medical devices，The applicant is required to provide the product certificate of the device when applying.，and proof of business premises。Please see below for the specific application process.。Medical device classification：The first category refers to，Regular management is sufficient to ensure its security、effectiveness of medical devices。The second category refers to，to its security、Medical devices whose effectiveness should be controlled。

The third category refers to，Implanted into human body;for support、sustain life;Potentially dangerous to human body，to its security、Medical devices whose effectiveness must be strictly controlled。

Class I medical devices：Basic surgical knives "Scalpel handle and blade、Skin grafting knife、wart peeling knife、lancet、Blade、razor、dandruff scraper、Pick a knife、sharp knife、Shukyakuto、manicure knife、Scalpels, etc.》Class II medical devices：1.General diagnostic equipment(6820)：thermometer、Sphygmomanometer 2.Physical therapy and rehabilitation equipment(6826)：Magnetic therapy equipment 3. Clinical testing and analysis instruments(6840)：Home-use blood glucose analyzer and test strips 4. Operating room、emergency room、Clinic equipment and appliances(6854)：Medical small oxygen concentrator portable oxygen generator;5.Medical hygiene materials and dressings(6864)：Use absorbent cotton、Medical skim gauze 6. Medical polymer materials and products(6866)：condom、Class III medical devices such as contraceptive caps：1.Disposable sterile medical devices (1) Disposable sterile syringes (2) Disposable infusion sets;(3) Disposable blood transfusion set (4) Disposable anesthesia puncture kit (5) Disposable intravenous infusion needle (6) Disposable sterile injection needle (7) Disposable plastic blood bag (8) Disposable blood collection device (9) Disposable buret type infusion set 2. Orthopedic implant medical devices (1) Surgical implant joint prosthesis (2) Disposable sterile medical devices、hearing aid、Contact lenses and care solutions、In vitro diagnostic reagents、6846Implant materials and artificial organs、6877Except for interventional devices)Waiting for application conditions for Shenzhen Medical Device Business License：(1) Have a quality management organization or full-time quality management personnel that is suitable for the business scale and scope of business。

Quality management personnel should have relevant professional academic qualifications or professional titles recognized by the state。(2) Have a relatively independent business location commensurate with the business scale and scope of business。(3) Have storage conditions suitable for the business scale and business scope，Including products that comply with the characteristics of medical devices

Require

storage facilities、equipment。

(4) A sound product quality management system should be established and improved，including procurement、Incoming goods acceptance、Warehousing and storage、Warehouse review、Quality tracking system and adverse event reporting system, etc.。(5) It should have technical training and after-sales service capabilities that are suitable for the medical device products it operates.，Or agree to have a third party provide technical support。(6) Personnel required by medical device companies：Corporation，Business person in charge，Quality manager，quality manager，inspector。

(7) Person in charge of the enterprise，Quality manager，Quality managers need a college degree or above and a medical major，Inspectors must have a technical secondary school degree or above and major in medicine(Academic qualifications do not include pharmacy major)。

Shenzhen Medical Device Business License

Process

：1、Submit medical device business license application materials to Shenzhen Food and Drug Administration；2、Food and Drug Administration document form review；3、Information formally accepted；4、Administrative review by relevant departments；5、On-site review；6、Administrative decisions of relevant departments；7、Make a certificate，issue certificate。

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