With the continuous integration of modern scientific and technological achievements, the medical device industry is not only closely related to the protection of human health, but also becomes an important embodiment of the development level of a country's comprehensive science, technology and manufacturing industry. As one of the important representatives of the high-tech industry, the medical device industry has become one of the fastest growing industries with the most active import and export trade in the world. In recent years, with the continuous improvement of China's overall level of science and technology, the export of medical devices has a great development. But what exactly is a medical device? What are the import and export requirements?

Medical instruments: 

Means instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials and other similar or related articles used directly or indirectly on the human body, including computer software required; Its effects are obtained mainly through physical and other means, not through pharmacological, immunological or metabolic means, or even though these means are involved but only in an auxiliary role.

Objective: 

Diagnosis, prevention, monitoring, treatment or remission of diseases; Diagnosis, monitoring, treatment, mitigation or functional compensation of injuries; Testing, replacing, regulating or supporting physiological structures or processes; Life support or maintenance; Pregnancy control; The examination of human samples to provide information for medical or diagnostic purposes.

Classification of medical devices

The state implements classified management of medical devices according to the degree of risk

The first kind of

Refers to the medical devices that can ensure their safety and effectiveness through routine management. Such as surgical instruments (knife, scissors, forceps, tweezers, hook), scraping board, medical X-ray film, operating clothes, operating caps, examination gloves, gauze bandages, drainage bags, etc.

The second type of

Refers to the medical instruments whose safety and effectiveness should be controlled. Such as medical suture needle, blood pressure needle, thermometer, electrocardiogram machine, electroencephalogram machine, microscope, acupuncture needle, biochemical analysis system, hearing aid, ultrasonic disinfection equipment, non-absorbable suture, condoms, etc.

The third kind

Medical devices that are potentially dangerous to human body and whose safety and effectiveness must be strictly controlled. Such as implantable pacemaker, contact lens, intraocular lens, ultra-provincial tumor focusing knife, hemodialysis device, implant equipment, vascular stent, comprehensive anesthesia machine, dental implant materials, medical absorbable suture, intravascular catheter, etc.

Warm prompt

To evaluate the risk degree of medical devices, it is necessary to consider the expected purpose, structural features, use methods and other factors of medical devices.

Regulations on the supervision and Administration of medical devices

Chapter II Registration and filing of medical device products

Article 13 Category I MEDICAL DEVICES shall be subject to product record management, while CATEGORY II and III MEDICAL DEVICES shall be subject to product registration management.

The registrants and archivists of medical devices shall strengthen the quality management of the whole life cycle of medical devices, and assume responsibility for the safety and effectiveness of medical devices in the whole process of development, production, operation and use in accordance with the law.

Article 14 The following materials shall be submitted for the filing of Category I medical device products and the application for the registration of Category II and III medical device products:

(1) Product risk analysis data; (2) technical requirements for the product; (3) Product inspection report; (4) clinical evaluation data; (5) Product specifications and label samples; (6) Quality management system documents related to product development and production; (7) other materials needed to prove the safety and effectiveness of the products.

Article 16 In applying for the registration of Category II medical device products, the registration applicant shall submit the registration application materials to the drug regulatory department of the people's government of the province, autonomous region or Municipality directly under the Central Government where the product is located. To apply for the registration of category III medical device products, the applicant shall submit the registration application materials to the drug regulatory department under The State Council.

For an overseas registration applicant who exports Category II or III medical devices to the territory of China, the enterprise legal person within the territory of China designated by the applicant shall submit to the drug regulatory department under The State Council the registration application materials and the certification documents of the competent department of the country (region) where the registration applicant is located approving the marketing of the medical devices. For innovative medical devices that have not been listed overseas, the competent authorities of the country (region) where the registration applicant is located may not submit the certification documents approving the marketing of the medical devices.

Chapter IV Operation and Use of medical instruments

Article 57 The imported medical devices shall be those that have been registered or put on record in accordance with the provisions of Chapter II of these Regulations.

Imported medical devices shall have instructions and labels in Chinese. The instruction manual and label shall comply with the requirements of these Regulations and relevant mandatory standards, and specify the country of origin of the medical device and the name, address and contact information of the enterprise legal person in China designated by the overseas medical device registrant and record holder. Where there is no instruction manual or label in Chinese or the instruction manual or label does not conform to the provisions of this Article, it shall not be imported. Where a medical institution urgently needs to import a small amount of Class II or class III medical devices for clinical purposes, it may import them upon approval of the drug regulatory department under The State Council or the people's government of a province, autonomous region or municipality directly under the Central Government authorized by The State Council. Imported medical devices shall be used for specific medical purposes in designated medical institutions.

It is prohibited to import expired, invalid, obsolete and other used medical instruments.

Article 58 The entry-exit inspection and quarantine authorities shall inspect the imported medical instruments according to law; Those that fail to pass the inspection shall not be imported.

Import and export of medical device products

Major export qualifications of medical device manufacturers:

(1)  Business license. (2) Obtain the domestic medical device production license and medical device product registration/filing certificate. If the importing country (region) has the requirement, the manufacturing enterprise shall also obtain the record of the medical device manufacturing enterprise of the drug administration department and apply for the issuance of the Export Sales Certificate of Medical Device Products. The production enterprise also needs to meet other management requirements of the drug regulatory department. (3) Obtain the right to import and export. The local commercial department shall go through the formalities for the record registration of foreign trade dealers and obtain the Record Registration Form for Foreign Trade Dealers. If they do not have the right to import and export, they may also be sold to enterprises that have obtained the right to export. (4) After the enterprise obtains the qualification, it shall apply for the record in the customs declaration unit. Import of medical instrumentsBusiness license. (2) Obtain the domestic medical device production license and medical device product registration/filing certificate. If the importing country (region) has the requirement, the manufacturing enterprise shall also obtain the record of the medical device manufacturing enterprise of the drug administration department and apply for the issuance of the Export Sales Certificate of Medical Device Products. The production enterprise also needs to meet other management requirements of the drug regulatory department. (3) Obtain the right to import and export. The local commercial department shall go through the formalities for the record registration of foreign trade dealers and obtain the Record Registration Form for Foreign Trade Dealers. If they do not have the right to import and export, they may also be sold to enterprises that have obtained the right to export. (4) After the enterprise obtains the qualification, it shall apply for the record in the customs declaration unit. Import of medical instruments

Imported medical devices shall have instructions and labels in Chinese. The instructions and labels shall comply with the provisions of the Regulations on the Supervision and Administration of Medical Devices and the requirements of relevant mandatory standards. The instructions shall also indicate the country of origin of the medical devices and the name, address and contact information of the enterprise legal person in China designated by the overseas medical device registrant and record holder.

The consignee of an import commodity subject to statutory inspection shall report for inspection to the exit and entry inspection and quarantine organ at the place of declaration on the strength of necessary documents such as contract, invoice, packing list, bill of lading and other relevant approval documents. Within 20 days after the clearance, the consignee shall inspect the import commodities required for legal inspection in accordance with Article 18 of the Regulations for the Implementation of the Law on Import and Export Commodity Inspection of the People's Republic of China at the destination declared by the consignee at the time of inspection. Import commodities subject to legal inspection shall not be sold or used without inspection.

Where a medical institution urgently needs to import a small amount of Class II or class III medical devices for clinical purposes, it may import them upon approval of the drug regulatory department under The State Council or the people's government of a province, autonomous region or municipality directly under the Central Government authorized by The State Council. Imported medical devices shall be used for specific medical purposes in designated medical institutions.

The contract, invoice, packing list and medical device record/registration certificate shall be provided during the customs declaration of imported medical devices.

Tip:

The imported medical devices shall be those that have been registered or put on record, and the validity period of the medical device registration certificate shall be 5 years. If the registration needs to be extended upon expiration of the validity period, an application for renewal of registration shall be filed with the original registration department six months before the expiration of the validity period. According to "on the import pharmaceuticals customs form 7 kinds of regulatory documents such as the implementation of networking verification announcement (the General Administration of Customs state drug administration announcement no. 148, 2018) requirements, the nationwide implementation of a license for the import and export of ganga drugs (including narcotics import permit, narcotics export permit, psychotropic drug import permit, psychotropic drugs, export permission). Record/registration certificate of imported medical devices (including registration certificate of medical devices and record certificate of Class I medical devices), electronic data of Import Hygiene License for Cosmetics for Special Purposes, Import Hygiene License for Cosmetics for Non-Special Purposes, and electronic data of import and export goods declaration form shall be checked online.  

Frequently Asked Questions:

01 Are the imported medical device products subject to record management?

Answer: THE FIRST KIND OF MEDICAL INSTRUMENT EXECUTES PRODUCT RECORD MANAGEMENT, THE SECOND KIND, THE THIRD KIND OF MEDICAL INSTRUMENT EXECUTES PRODUCT REGISTER MANAGEMENT. (Reference document: Regulations on the Supervision and Administration of Medical Devices)

Our company has a batch of R&D and test medical devices that need to be imported to China, and we have not obtained the medical device registration certificate. May I ask how to operate in this situation?

Answer: ACCORDING TO "MEDICAL DEVICE SUPERVISION AND ADMINISTRATION REGULATION" REQUIREMENT, IMPORTED MEDICAL DEVICE NEEDS TO PROVIDE THE MEDICAL DEVICE REGISTRATION CERTIFICATE APPROVED BY the FOOD and DRUG supervision and administration department OF The State Council. For the research and development of medical devices for testing can be confirmed to the local food and drug supervision and administration departments to go through the declaration procedures.

Are EXPORT SALES CERTIFICATE OF MEDICAL DEVICE PRODUCTS AND EXPORT RECORD FORM OF MEDICAL DEVICE PRODUCTS APPROVED BY THE CUSTOMS?

A: If exports in vitro diagnostic reagents meet the requirements of the importing countries (regions) in 2021, according to the General Administration of Customs announcement no. 52 (on the entry and exit health quarantine on special goods announcement) parties on matters relating to the examination and approval requirements, the customs approval issued by the pharmaceutical supervisory and administrative departments at the same time the export application form of medical equipment and medical equipment product export sales confirmation, Both of them can be used as the relevant application materials for the approval of entry-exit health quarantine on special goods.