Business Background
A dental equipment supplier based in Guangzhou sold two dental chairs and one 3D dental X-ray machine to a dental clinic in Latvia. Due to a lack of familiarity with customs clearance procedures for medical equipment and EU import compliance regulations, the company engaged our firm to provide services including pickup, professional packing, ocean freight, and customs clearance. After the goods were transported to the Port of Riga, the buyer arranged for their own personnel to pick up the shipment.
Business Process
Pre-export compliance and documentation preparation — Equipment packing — Pickup in Guangzhou — Reinforced packaging + labeling — Booking shipping space 2 weeks in advance — Chinese export customs clearance — International transport — Customs clearance and tax payment upon arrival — Retention of compliance documentation for the EU market — Handover to the recipient for pickup.
Key Considerations Throughout the Entire Process
I. Core Risk Warnings Regarding Compliance Certification
1. The EU MDR regulations are strictly enforced. The use of certificates issued under the now-defunct MDD is strictly prohibited. Devices classified as Class IIa or higher must be assessed and certified by a Notified Body accredited under the MDR. Certificates can be verified in the EU’s EUDAMED database to avoid having goods detained or returned due to counterfeit or duplicated certificates.
2. Technical documentation must be complete and verifiable, as EU regulatory authorities may conduct random inspections at any time. Failure to provide core documents such as clinical evaluation reports, risk management documentation, and software validation files may result in product recalls, fines, or even market bans.
3. The EU Authorized Representative must be a compliant entity established within the EU with the capability to handle medical device compliance. It is strictly prohibited to use unqualified individuals or shell companies as EU Authorized Representatives; otherwise, customs clearance will be rejected outright.
II. Logistics and Packaging Considerations
1. Dental equipment is precision machinery; packaging must include shock-proof, moisture-proof, and anti-static measures. For oversized or overweight equipment, lifting points and the center of gravity must be clearly marked. When constructing wooden crates, ensure IPPC fumigation is completed in advance to avoid customs clearance delays caused by missing markings.
2. Confirm the port’s free demurrage and free storage periods in advance, and allow sufficient time for customs clearance to avoid high additional costs resulting from port or container delays. For high-value equipment, it is recommended to purchase all-risk insurance to cover the risk of cargo damage during transit.
3. If choosing DDP (Delivered Duty Paid) terms, ensure the EU EORI number and tax compliance are secured in advance, and engage a local customs broker with experience in medical device clearance to avoid cargo detention due to incorrect tax calculations or compliance issues.
III. Customs Clearance Documents and Declaration Requirements
1. The shipper and consignee information, product model, HS code, quantity, and declared value must be exactly consistent across all customs clearance documents; any discrepancies are strictly prohibited. Commercial invoices must accurately declare the value of the goods; under-declaration or misrepresentation will result in customs audits, fines, or even seizure of the goods.
2. Latvian Customs requires that invoices clearly state the terms of trade. For corporate recipients, the company registration number must be provided; for individual recipients, an ID or passport number must be provided. The IOSS tax number must be indicated on both the waybill and the invoice.
3. Used dental medical equipment must additionally comply with EU regulations for used medical devices. Complete the compliance review in advance to avoid shipment returns due to prohibited import provisions.