All of the enterprises that operate the medical apparatus must have a business license of medical apparatus, if not the administrative department for industry and commerce shall not issue a business license and also shall not import or export the medical apparatus. A＂Business license of medical apparatus＂is valid for 5 years.
In China, medical apparatus means instruments, equipment, appliances, materials, or other articles used alone or in combination for a human. Including the required software, the effects on the human surface and body are not obtained by pharmacological, immunological or metabolic means, but these methods may be involved and play a supporting role.
＊ The classification of the applicable license of medical apparatus ＊
According to SFDA regulations, the license of medical apparatus applications are divided into three categories:
|First kind of medical apparatus:
Through routine management sufficient to ensure safety and effectiveness such as
most of the surgical instruments, surgical instruments, X-ray film, X-ray protection
device, automatic electrophoresis instrument, centrifuge, microtome, dental chair,
boiling sterilizer, gauze bandage, band-aid, surgical gown, surgical cap, mask,
urine collecting bag, etc.
|Second kind of medical apparatus:
Product’s mechanism has been achieved international and domestic accreditation,
mature technology, safety, and effectiveness can be controlled such as
thermometers, blood pressure meters, ECG diagnostic instruments, medical
endoscopes, dental synthetic instruments, medical absorbent cotton, etc.
|Third kind of medical apparatus:
Refers to implant human body, for life support or the technical structure is
complex and potentially dangerous to the human body. Safety and effectiveness
must be strictly controlled such as an implantable cardiac pacemaker,
extracorporeal shock wave lithotripsy, endoscopy, ultrasonic scalpel, laser surgical
equipment, transfusion apparatus, disposable infusion set, disposable sterile
injector, CT devices, etc.
Different categories of products require different documents for registration, the classification of medical devices in China is different from that in other countries. If there is no clearly stated product in the “classified catalog” published by SFDA, before applying for the registration of medical equipment qualification certificate, it is necessary to submit the classified application to the SFDA standard, after the product classification has been made at the standard, it may be declared in accordance with the relevant procedures and requirements. In China, the import and export of medical instruments are more stringent, and professional agents should be taken to avoid wasting time and cost.
＊ Document For Application ＊
- Product registration of medical apparatus. The classification registration system for registration of China medical apparatus products:
(1) One category of products to apply for a filing system, the product registration certificate shall be issued upon approval by the Municipal Drug Administration of the community.
(2)Two types and three types of products perform product registration, the program is mostly substantive review, the implementation of the two categories and three types of product registration is divided into trial products and quasi-product registration system Two types of products are registered by the provinces, municipalities directly under the central government and drug administration examination and approval issued a certificate of registration, three kinds of products are registered by the State Drug Administration approved and issued a registration certificate. The import of medical apparatus in China shall be examined and approved by the State Drug Administration, and the registration certificate of imported medical apparatus shall be issued.
- Supervision and sampling of import of medical apparatus products in China.
(1) Evaluation and supervision of imports of medical apparatus products in China：Conduct quality assessment and comprehensive evaluation of the same breed or similar products.
(2) Targeted supervision and sampling of import of medical apparatus products in China：Supervision and inspection of quality complaints, reports or quality supervision, random inspection, inspection has failed records and other medical apparatus.
＊ Application documents for China medical apparatus qualification certificate ＊
- A report of application for the establishment of medical apparatus enterprise, fill in or print “Medical equipment operating enterprise license application form”.
- Issued by the administrative department for industry and commerce “Notice of pre-approval of enterprise name”.
- Personnel information.
(1) As the legal representative and the person in charge of the enterprise’s identity card, residence booklet or relevant documents issued by the public security organs and certificates of education, health certificate.
(2) Enterprise quality control personnel identity cards, educational background or professional and technical job certificate, copy and personal resume, employment agreement, health certificate.
(3) Corporate personnel roster and health certification. The roster includes: name, gender, age, professional / technical position / education, position / position.
- Enterprise organizations and functions; enterprises draw up organizational chart, clearly and clearly identify the division of labor within the enterprise, as well as the status of enterprise staff functions.
- The registered location of the enterprise, the location map of the warehouse address, the floor plan (indicating the area), and the certificate of property ownership (or lease agreement).
- Enterprise product quality control system files and storage facilities and equipment catalog.
- Catalog of enterprises. The following contents are included in the catalogue：Name of product, manufacturer, specification, registration number, and instructions for storage conditions and requirements of corresponding products.
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