Imported medical devices should be registered or filed in accordance with relevant regulations. The customs shall inspect imported medical devices in accordance with the law; if they fail the inspection, they shall not be imported. In principle, imported medical devices shall be inspected at the declared destination. For imported medical devices that need to be inspected in conjunction with installation and debugging, the place of use should be specified when applying inspection, and the inspection should be carried out at the place of use.

      Imported cardiac pacemakers are inspected at designated ports such as Beijing, Shanghai, and Hainan, and tested at designated nationally recognized medical device testing institutions. Imported high-risk ventilators are inspected at designated ports such as Beijing, Tianjin, Liaoning, Shanghai, Zhejiang, Shandong, Hubei, and Guangdong. Imported other ventilators shall be inspected and supervised in accordance with the principle of destination inspection.

Customs Documents

  1. When declaring imported medical devices, you should provide contracts, invoices, packing lists, and medical device filing/registration certificates;
  2. Imported medical devices should have Chinese instructions and Chinese labels. Instructions and labels shall comply with the provisions of these Regulations and the requirements of relevant mandatory standards. The instructions shall state the origin of the medical device and the name, address and contact information of the domestic corporate legal person designated by the overseas medical device registrant or filer;
  3. Automatic import license (required for some equipment with O certificate), compulsory certification certificate (required for some equipment), and importer’s business license;
  4. The customs conducts online verification of the electronic data of imported medical device filing/registration certificates (including medical device registration certificates and Class I medical device filing certificates) and the electronic data of imported medical device product customs declaration forms.

Qualifications That the Receiving Units for Medical Device Import Declaration Should Have:

  1. Medical device business license;
  2. Business license (it should be noted that the business scope includes a license to sell medical devices);
  3. Import and export rights (if you don’t have it, you can find a qualified import and export company to import as your agent);
  4. Medical equipment that contains pharmaceutical ingredients must provide China Compulsory Certification Certificate (Special Item Approval Form);
  5. Some equipment requires an automatic import license (O license).

Medical Device Import Requirements

  1. Imported medical devices must be registered or filed medical devices.
  2. The medical device registration certificate is valid for 5 years. If it is necessary to renew the registration upon expiration of the validity period, an application for renewal of registration shall be submitted to the original registration department 6 months before the expiration of the validity period.
  3. Regarding the validity period of the medical device registration certificate. “Notice of the Food and Drug Administration on Issues Concerning the Implementation of Registration Management Measures for Medical Devices and In Vitro Diagnostic Reagents” (Food and Drug Administration No. 247, 2015): Medical devices approved for registration refer to the registration certificate and attachments of the medical device with consistent content and produced within the validity period of the medical device registration certificate.
  4. If a medical institution needs to import a small amount of Class II or Class III medical devices due to urgent clinical needs, it may import them with the approval of the drug regulatory department of 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 should be used for specific medical purposes in designated medical institutions.

Medical Device Import Foreign Trade Agent Tax Exemption Application Process

      Imported instruments and equipment used by non-profit medical, scientific research, and teaching units for physical rehabilitation, scientific research, and teaching that meet the tax exemption conditions are exempt from import duties.

  1. First apply for the “Confirmation Letter of Domestic-Funded Projects Encouraged by the State” from the project management department, and go through the tax reduction and exemption procedures at the customs with the confirmation letter.
  2. Customs filing and approval process for tax reduction and exemption projects:
    • The applicant unit provides the documents required for tax reduction and exemption filing;
    • The applicant unit fills out the “Application Form for Tax Exemption Certificate” and goes to the pre-recording center to pre-record;
    • The applicant unit shall submit the required documents and pre-recorded forms to the Customs for preliminary review;
    • Customs conducts three-level approval.

Cargo Attributes

(1) Medical Devices:

      It refers to products defined and described in the “First Class Medical Device Product Catalog” or “Medical Device Classification Catalog”. Among them, the cargo attributes of Class I medical devices are “Class 34-I Medical Devices”, the cargo attributes of Class II medical devices are “Class 35-II Medical Devices”, and the cargo attributes of Class III medical devices are “Class 36-III Medical Devices”.

(2) Medical Device Parts:

      Within the scope defined and described in the “Class I Medical Device Product Catalog” or “Medical Device Classification Catalog”, the parts and components provided to medical device manufacturers as production materials to produce medical devices or the “structure and composition” in the medical device registration certificate If the assembled parts specified in the column are used for the original registered product for the purpose of replacement of consumables, after-sales service, maintenance, etc., the goods attribute is “37-Medical Device Parts”.

(3) Non-medical Devices:

      The product principle, structure, function, etc. are similar to medical devices, but do not fall within the definition of medical devices in the “Regulations on the Supervision and Administration of Medical Devices”. The attribute of the goods is “38-Non-Medical Devices”.