With the rapid expansion of China's dental healthcare sector, there has been sustained growth in demand for high-end imported devices including dental implants, orthodontic appliances, and dental imaging equipment. This guide provides a systematic overview of regulatory requirements and operational considerations for Customs clearance of imported dental medical devices.
I. Import Regulations on Dental Medical Devices: Classification and Market Access Standards
Pursuant to the Regulation on the Supervision and Administration of Medical Devices, dental medical devices are classified and regulated according to below risk levels:
Class I: Low-risk devices that can be guaranteed safe and effective through routine management. Examples include dental mirrors, dental wax, and non-sterile oral hygiene tools.
Class II: Medium-risk devices requiring stringent controls to ensure safety and efficacy. Examples include clear aligners and dental hand pieces.
Class III: High-risk devices necessitating special control measures to ensure safety and performance. Examples include dental implant systems and bone grafting materials.
Class I devices are subject to product record filing, whereas Class II and Class III devices require product registration approval.
Customs Advisory: Overseas manufacturers intending to export medical devices to China must appoint a legally registered Chinese entity as their local representative to submit registration or filing documentation to the Medical Products Administration under the State Council. Importation of dental medical devices is only permitted upon obtaining the Registration Certificate/Filing Document for Imported Medical Devices.
II. Navigating Customs Clearance for Importation of Dental Medical Devices: A Step-by-Step Guide
(I) Pre-Declaration Assessment
HS Code Classification: Dental medical devices are generally classified under HS code series 9018 (90184990, 90184100, 90184910), with substantial tariff variations among specific product categories.
Inspection and Quarantine Requirements: As regulated inspection commodities, dental medical devices undergo destination inspection. Devices containing liquid components or biological coatings (e.g., certain bone graft materials) require additional health quarantine declarations.
Product Categorization Verification: Prior to importation, product classification must be verified through the official website of National Medical Products Administration (NMPA). Class II and III medical devices require declaration of registration numbers in standardized format -NMPA Import Medical Device Registration [Year] No. XXXX. Customs conducts electronic cross-verification between the digital data of Registration Certificate for Imported Medical Devices and that of the Customs Declaration Form for Imported Medical Devices. Importation is prohibited if verification fails.
(II) Import Declaration Procedures
The consignee of imported medical devices must submit the following documents through the China International Trade Single Window to local Customs for declaration:
1. Import Medical Device Registration Certificate and Business License;
2. For devices containing pharmaceutical components, the China Compulsory Certification (CCC) and Special Item Approval Documentation are required;
3. Automatic Import License for specific device categories;
4. Supporting materials including product photographs, nameplate information, technical specifications, intended use, and Chinese-version instructions of the imported dental medical device;
5. Commercial documentation related to the dental medical device such as import contracts, packing lists, commercial invoices, and any additional required certificates for importation.
(III) Destination Inspection
The consignee of imported medical devices shall apply for inspection with the destination Customs within 20 days after Customs clearance and release at the declaration Customs. The destination Customs shall determine the inspection method and sampling ratio based on the risk category of the imported medical device and the classification of the importing entity, conduct inspection accordingly. Devices that fail inspection shall not be imported, and may only be sold or used after passing inspection.
III. Common Compliance Issues in Importation of Dental Medical Devices
(I) Absence of Valid Registration Certificate for Medical Device
Imported medical devices must possess either registration or filing documentation in accordance with Regulation on the Supervision and Administration of Medical Devices. Non-compliant devices are prohibited from importation. Customs authorities have identified multiple cases involving unregistered medical devices, including intraoral scanners and preparation devices for root canal treatment, which were subsequently deemed non-compliant and subject to mandatory re-export procedures.
(II) Discrepancies Between Shipment Contents and relevant Registered and Filled data
Customs inspections have revealed instances where imported dental comprehensive treatment units did not match the approved models specified in the submitted Registration Certificates for Medical Device. In such cases where importers failed to produce valid registration certificates for the actual shipped dental comprehensive treatment units, the goods were lawfully determined non-compliant and processed for return shipment.
(III) Non-compliant Labeling and Concealed Inclusion of Non-CCC-Certified Products
Imported medical devices must be accompanied by Chinese-version instructions and labels that comply with the relevant provisions of the Regulation on the Supervision and Administration of Medical Devices. During regulatory inspections, common violations include non-compliant Chinese labeling and concealed shipments containing medical devices without mandatory China Compulsory Certification (CCC) marks.
(By Peng Ying, Jin Danfeng, and Lai Yuxi)
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