Knowledge You Shall Know and Points you Shall Pay Attention to When Importing Oral Instruments/Devices to China
Oral health is an important part of human body health. WHO has listed oral health as one of the top ten standards of human body health. In recent years, the numbers of patients with oral diseases in China have been increasing. The market of oral instruments in China has been developing fast.
China is a big importing country of oral instruments in the world. China strictly supervises imported oral instruments and devices in accordance with relevant laws and regulations so as to safeguard the safety of national gateway and protect the legitimate rights and interests of the domestic consumers. Hereunder, we, as a China customs broker, introduce the detailed flow of the import of oral instruments and devices.
Registration & Filing
Pursuant to Regulations on the Supervision and Administration of Medical Devices, foreign manufacturers that export medical devices to our country shall let their representative organizations established within the territory of our country or appoint enterprise legal persons in our country as agents to submit registration or filing materials at CFDA. Oral Instruments and devices can only be imported after obtaining the Registration/Filing Certificate for Imported Medical Devices.
Class one Medical Devices shall obtain filing certificate. Class two and three medical devices shall obtain registration certificate.
Note: Classification Management has been implemented on medical devices. Article six of the Regulations on the Supervision and Administration of Medical Devices stipulates that our country implements classification management on medical devices based on their risk levels.
Class one are low-risk medical devices that can be safely and effectively managed routinely.
Class Two are medical devices with moderate risks that require strict control and management to ensure their safety and effectiveness.
Class Three are medical devices with high risks which shall be strictly controlled and managed via special measures to ensure their safety and effectiveness.
Class Three are medical devices with high risks which shall be strictly controlled and managed via special measures to ensure their safety and effectiveness.
Chinese User’s Manual, Chinese Labels
Regulations on the Supervision and Administration of Medical Devices stipulate that imported medical devices shall have Chinese user’s manual and China labels. The user’s manuals and labels shall conform to the stipulations of the Regulations and the requirements of relevant compulsory standards. The user’s manual shall specify the country/region of origin, the name, address and contact info of the domestic enterprise legal person appointed by the foreign medical devices registrant / filing person. Medical devices without Chinese user’s manual and Chinese labels or Medial devices whose Chinese user’s manual and/or Chinese label do not conform to the Regulations shall not be imported.
Import Declaration
The consignee of the oral instruments and devices shall declare to customs of the entry port and shall apply for inspection at destination customs within 20 days from the date port customs releases the shipment.
Required documents for China customs clearance of Imported Oral Instruments and Devices
1. Registration/Filing Certificate for Imported Medical devices and Business License for Medical Devices
2. Instruments or devices that contain medicine reagent(s) shall provide Chine Compulsory Certificate which is known as Approval Sheet for Special Articles
3. Some instruments/devices shall provide automatic import license.
4. Pictures, name plate, technical specifications, end usage, Chinese user’s manual, etc., of the oral instruments/devices.
5. Contract, packing list , invoice and other documents
Destination Inspection
Oral instruments/devices whose HS codes are 90184990, 90184100, and 90184910 are legal inspection commodities and shall accept destination inspection. After being released by port customs and moved out of the supervision zone of port custom, the consignee shall arrange transportation and storage by themselves and shall not sell or use the imported oral instruments/devices before they are inspected by the destination customs.
Attention Please
China customs inspects and supervises imported oral instruments and devices in accordance with the relevant laws and regulations, and crack down illegal importations of oral instruments and devices to safeguard the lives, health and safety of people. Hereunder, we, an China customs agent , share some unqualified oral instruments cases detected by China customs and hope them can help you understand some legal requirements for imported oral instruments and devices.
Case 1, lack of registration/filing certificate for medical devices
Recently, China continuously detected imported dental scanners, x-ray tube assemblies, lower limb rehabilitation training machines, disposable sterile syringes, root canal preparation machines and other medical devices that had no registration/filing certificate. China determined that the above-mentioned goods were unqualified to import and carries out return processes on them.
Note: Before importing into China, medical devices shall obtain registration/filing certificate at CFDA. Imported medical devices shall be those registered or filed in accordance with the Regulations on the Supervision and Administration of Medical Devices. Those not registered or filed can not be imported.
Case 2, imported model not consistent with the registered info.
When inspected on an import shipment containing dental units, customs inspectors found that the actual model number did not match the model number as indicated on the registration certificate provided by the consignee. And the consigned could not provide the correct registration certificate for the imported dental unit. China customs determined that the mentioned goods unqualified for importing and ordered the consignee returned the shipment.
Note: the actual goods shall be consistent with the info as shown on the registration certificate.
Registered medical devices refer to those consistent with prescribed contents of the registration certificate and the appendix and manufactured with the validity of the registered certificate. Medical devices that do not match the info as prescribed on the registration/filing certificate are not allowed to import.
Below requirements shall be paid attention to as well.
1.Pursuant to the Regulations on the Supervision and Administration of Medical Devices, used medical devices that have been used, expired, invalid and obsolete are banned from import.
2.The transportation and storage of medical devices shall conform to the requirements as described on the user’s manual and labels. Proper and matching measures shall be taken on the medical devices that that special requirements for temperature, humidity and other environmental conditions to ensure the safety and effectiveness of the medical devices. In case that the use of the containing medical devices are affected because the goods are wet or the packing is squeezed or damaged, China customs will return or destroy the subject medical devices in accordance with relevant laws and regulations so as to protect the lives, health and safety of consumers.
3.Imported medical devices shall not be used or sold before they are inspected by destination customs as qualified.
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