In January 2023, we facilitated the import of a batch of high-end Japanese beauty devices through Shanghai Pudong International Airport. As Class II...Medical EquipmentThese products have special characteristics in terms of HS code classification (usually classified under 9019.2000) and regulatory requirements. Leveraging our 15-year accumulated database of import solutions, we have customized the "Air Transportation+預(yù)檢驗”的組合方案,從貨物起飛到完成清關(guān)僅用3周時間,比行業(yè)平均周期縮短40%。
We initiated the document pre-review process two weeks in advance, focusing on three key documents:
- Officially issued by JapanIt is recommended to verify through the following methods:(Form A)
– Pre-shipment Inspection Report(Pay special attention to electrical safety indicators)
– Chinese-Japanese BilingualMedical Device InstructionsPlease translate the following Chinese into English:
(Compliant with China's "Regulations on the Instructions and Labels of Medical Devices")
Opt for NCA (Nippon Cargo Airlines) direct flights, leveraging its "Constant Temperature Cold Chain Cabin" feature to ensure the stability of the beauty device's core components. The actual transit time is only 36 hours, yet we have specifically marked the airway bill with a "KEEP UPRIGHT" label to mitigate the risk of cargo tipping during customs inspection.
Complete the declaration in advance through the pre-entry system before the flight lands:
- Confirmation of declaration elements (key parameters such as material, function, voltage, etc.)
– 3CApplication for Certification Exemption (for Certain Low-Frequency Beauty Devices)
- Customs duty guarantee filing (the comprehensive tax rate under the summary taxation mode is approximately 8.4%)
For medical device products, Shanghai Airport Customs focuses on inspecting:
① The product nameplate matches the declared specifications.
② Power adapter CCC certification
③ Compliance of Medical Claims in the Instructions
We prepared in advance.Electronic Filing of Inspection Reports(Including test data such as RoHS and EMC) reduces the inspection cycle to 12 working days.
Since the implementation of the adjusted "Medical Device Classification Catalog" in 2023, we have promptly updated the evaluation criteria:
- Beauty devices with an energy intensity ≤50mW/cm2 are classified as Category II.
– RF equipment requires an additional SAR value report.
These professional judgments saved the client at least 20 days of classification and identification time.
By analyzing customs clearance data of similar products over the past three years, we recommend the following to our clients:
√ Adopt the "FOB + Air Freight" combination to reduce logistics costs.
√ Apply for the "Medical Device Marketing Authorization Holder (MAH)" pilot qualification
√ Utilize the tariff reduction policies under the RCEP agreement
The final comprehensive cost was reduced by 15% compared to the customer's expectations.
Establish a three-tier risk early warning mechanism:
1) Pre-declaration product compliance screening
2) Reporting Abnormal Conditions During Transportation
3) Immediate response of technical data during inspection
In this case, the compliance risk caused by Japanese labeling on the product nameplate was successfully avoided.
Leverage the synergy of branch offices in Shanghai/Xiamen/Dongguan, etc.:
→ The Shanghai team is responsible for airport customs clearance.
→ Xiamen Laboratory assists in sample testing
→ Dongguan warehouse provides temporary storage and distribution services.
Achieve a one-stop solution for "port clearance + multi-location distribution."
Trend 1: The General Administration of Customs' 2023 new regulations require all beauty devices to be clearly labeled as "non-medical use."
Trend 2: Pudong Airport pilots a "Fast Track for Biomedical Equipment," where eligible products can enjoy an 8-hour customs clearance.
Trend 3: Japanese exporters have begun providing technical documentation in Chinese, reducing the preparation time for declarations by approximately 30%.
From this case, it can be seen that professionalismImport RepresentationWe have evolved from a simple "customs clearance service provider" to a "trade compliance steward." For special categories like medical devices, initiating compliance planning 30 days in advance, establishing a comprehensive technical documentation system, and leveraging regional preferential policies will serve as the three key strategies to enhance import efficiency.
? 2025. All Rights Reserved. Shanghai ICP No. 2023007705-2 PSB Record: Shanghai No.31011502009912