(1) A valid medical device registration certificate or medical device filing certificate.
For overseas registrants who export Class I medical devices to my country, the designated domestic legal person shall submit the filing materials to the State Council Drug Administration.
For overseas registrants who export Class II and Class III medical devices to my country, the designated domestic legal person shall submit the registration application materials to the State Council Drug Administration.
(2) For medical devices included in the “Catalogue of Products Subject to Compulsory Product Certification”, a compulsory product certification certificate is required.
(3) Some medical devices require an automatic import license (when the regulatory certificate code contains 0).
(4) Chinese instructions, Chinese labels, equipment photos, nameplates, technical parameters, end use, etc. that comply with regulations.
(5) Import contracts, packing lists, invoices.
(6) HS code selection.
The tax numbers of medical devices are mainly concentrated in 9018, 9021, 9022, 9402 and other items. When declaring imports and exports, you can find the corresponding tax numbers according to different products.
Import inspection requirements
Customs will inspect imported medical devices in accordance with the law; those that fail the inspection shall not be imported.
(I) Entry verification
Imported and exported medical devices must obtain a record or registration certificate from the national drug supervision and administration department, and the record or registration certificate number should be actively filled in when declaring imports and exports.
Customs will conduct online verification and automatic comparison of the electronic data of the record/registration certificate of imported medical devices (including medical device registration certificate and first-class medical device record certificate) and the electronic data of the import medical device product declaration form.
(II) Commodity inspection
The commodity inspection standards are as follows:
(1) Check whether the commodity information, declaration information and access information inspected on site are consistent.
(2) Verify whether the relevant information on the nameplate of the imported medical device is consistent with the manufacturer, product name, model, etc. that have been filed or registered.
Import inspection location
In principle, imported medical devices are inspected at the declared destination. Customs will also conduct port or destination inspections on imported medical devices in accordance with the control instructions; those that fail the inspection shall not be imported.
For imported medical devices that need to be inspected in conjunction with installation and commissioning, the place of use shall be clearly stated at the time of declaration, and the inspection shall be carried out at the place of use. For example, imported pacemakers are inspected at designated ports such as Beijing, Shanghai, and Hainan, and are tested at designated nationally recognized medical device testing institutions.