【 Customs Knowledge 】 Teach you how to import and export
source：http://www.jtia56.cn time：2023-10-10 21:18:40
Teach you how to import and export medical devices
With the continuous integration of modern technological achievements, the medical device industry is not only closely related to the protection of human health, but also becomes an important manifestation of a country's comprehensive level of technology and manufacturing development. As one of the important representatives of high-tech industries, the medical device industry has become one of the fastest growing and most active industries in import and export trade worldwide. In recent years, with the continuous improvement of China's overall technological level, there has been significant development in the export of medical devices. But what exactly is a medical device? What are the types? How to import and export medical devices?
Medical devices:
Refers to instruments, equipment, instruments, in vitro diagnostic reagents and calibrators, materials, and other similar or related items directly or indirectly used in the human body, including required computer software; Its effectiveness is mainly obtained through physical and other means, not through pharmacology, immunology, or metabolism, or although these methods are involved, they only play an auxiliary role.
Purpose:
Diagnosis, prevention, monitoring, treatment or relief of diseases; Diagnosis, monitoring, treatment, relief or functional compensation of injuries; Testing, substitution, regulation, or support of physiological structures or processes; Support or maintenance of life; Pregnancy control; Provide information for medical or diagnostic purposes by examining samples from the human body.
Classification of Medical Devices: National Requirements for Medical Devices
Implement classified management based on risk level
first kind
Medical devices that can ensure their safety and effectiveness through routine management, such as surgical instruments (knives, scissors, forceps, forceps, hooks), scraping plates, medical X-ray films, surgical gowns, surgical caps, examination gloves, gauze bandages, drainage bags, etc.
Category 2
Medical devices whose safety and effectiveness should be controlled
Such as medical suture needle, blood pressure needle, thermometer, electrocardiograph, electroencephalograph, microscope, acupuncture and moxibustion needle, biochemical analysis system, hearing aid, ultrasonic disinfection equipment, non absorbable suture, condom, etc.
Third category
Medical devices that pose potential risks to the human body and must be strictly controlled for their safety and effectiveness
Such as implantable pacemakers, corneal contact lenses, artificial lenses, ultra economical tumor focusing knives, hemodialysis devices, implantation equipment, vascular stents, comprehensive anesthesia machines, dental implant materials, medical absorbable sutures, intravascular catheters, etc.
Kind reminder
When evaluating the risk level of medical devices, factors such as the expected purpose, structural characteristics, and usage methods of the medical device should be considered.
Regulations on the Supervision and Administration of Medical Devices
Chapter 2 Registration and Filing of Medical Device Products
Article 13: The first category of medical devices shall be subject to product registration management, while the second and third categories of medical devices shall be subject to product registration management.
Medical device registrants and registrants shall strengthen the quality management of the entire life cycle of medical devices, and bear responsibility for the safety and effectiveness of traditional Chinese medicine medical devices throughout the development, production, operation, and use process in accordance with the law.
Article 14: For the registration of Class I medical device products and for the registration of Class II and Class III medical device products, the following documents shall be submitted:
（1） Product risk analysis data;
（2） Product technical requirements;
（3） Product inspection report;
（4） Clinical evaluation data;
（5） Product manual and label sample;
（6） Quality management system documents related to product development and production;
（7） Other materials required to prove the safety and effectiveness of the product.
Article 16: To apply for the registration of Class II medical device products, the registration applicant shall submit the registration application materials to the drug regulatory department of the local province, autonomous region, or municipality directly under the central government. To apply for the registration of Class III medical device products, the registration applicant shall submit the registration application materials to the drug regulatory department of the State Council.
For overseas registration applicants who export Class II and Class III medical devices to China, their designated domestic enterprise legal representative shall submit registration application materials and proof documents from the competent authorities of the country (region) where the registration applicant is located that allow the medical device to be sold on the market to the drug regulatory department of the State Council. Innovative medical devices that have not been listed overseas may not be required to submit proof documents from the competent authorities of the country (region) where the registration applicant is located that allow the medical device to be listed for sale.
Chapter 4 Operation and Use of Medical Devices
Article 57: Imported medical devices shall be registered or filed in accordance with the provisions of Chapter 2 of these Regulations.
Imported medical devices should have Chinese instructions and labels. The instructions and labels shall comply with the provisions of this Regulation and relevant mandatory standards, and shall specify the origin of the medical device and the name, address, and contact information of the domestic enterprise legal person designated by the overseas medical device registrant and registrant in China. If there is no Chinese instruction manual or label, or if the instruction manual or label does not comply with the provisions of this article, it shall not be imported. Medical institutions that urgently need to import a small amount of Class II and Class III medical devices due to clinical needs may import them with the approval of the drug regulatory department of the State Council or the people's governments of provinces, autonomous regions, and municipalities authorized by the State Council. Imported medical devices should be used for specific medical purposes within designated medical institutions. Prohibit the import of expired, expired, and obsolete medical devices that have already been used.
Article 58: Entry exit inspection and quarantine institutions shall conduct inspections on imported medical devices in accordance with the law; Those that fail the inspection shall not be imported.
Import and export of medical device products
Main export qualifications of medical device manufacturing enterprises
① Business license.
② Obtain a domestic medical device production license and a medical device product registration/filing certificate. If the importing country (region) has requirements, the production enterprise must also obtain the medical device production enterprise registration from the drug regulatory department and apply for the issuance of the "Medical Device
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