How to choose a reliable denture export agency company?

As a Class II medical device, denture exports need to meet dual compliance requirements:Production End QualificationsIncluding ISO 13485 quality system certification and Chinese medical device registration certificate;The market access qualifications of the target marketVary according to the export region:

• EU market: CE certification (needs to comply with the MDR regulation)
• US market: FDA 510(k) pre - market notification
• Japanese market: PMDA certification
• Southeast Asian market: Most countries require ISO certification + local health department filing

The latest change in 2025: The EU MDR transition period has been extended to 2027, but the MDR standard has been mandatory for new CE certification applications. It is recommended to start the certification process 6 - 8 months in advance.

How to select reliable denturesExport agentThe company?

Professional medical devicesExport agentShould possess the following core capabilities:

• Qualification verification ability
  • Be familiar with the medical device classification rules of various countries
  • Be able to provide pre - assessment of regulations in the target market
• Logistics control system
  • Temperature - controlled transportation equipment (Some resin materials require a constant temperature of 15 - 25℃)
  • Special warehousing system for medical devices
• Risk response experience
  • Case in 2024: A certain agency successfully handled the customs clearance delay caused by impression materials by the South Korean MFDS
  • Pre - review service for FDA surprise inspections

What are the special logistics requirements for exporting dentures?

Different from ordinary commodities, special attention should be paid to the transportation of dentures:

• Packaging specifications: Double - layer sterilized packaging + shock - proof design (refer to ASTM D4169 test standard)
• Document preparation: A biocompatibility report (ISO 10993 series) should be attached
• Effect of transportation: For products made of resin materials, it is recommended to control the entire transportation time within 21 days

Recommended plan in 2025: The charter flight route from Shanghai to Los Angeles can achieve 5 - day door - to - door delivery. The cost increases by 40% compared with conventional transportation, but customer satisfaction increases by 65%.

What potential risks need to be noted in emerging markets?

For rapidly growing markets such as Southeast Asia and the Middle East, be vigilant:

• Certification Traps: The Indonesian BPOM requires local testing samples
• Cultural Differences: In the Middle East region, a production certificate compliant with Islamic law needs to be provided
• Risk of Payment: It is recommended to adopt the payment method of 30% advance payment + balance payment upon seeing the bill of lading copy

Typical Case: In 2024, a Shenzhen manufacturers entire container of goods was detained at the Port of Jeddah for 47 days due to not obtaining the Saudi SFDA certification, resulting in additional costs of $120,000.

How to control the comprehensive cost of denture exports?

Cost Optimization is achieved through four dimensions:

• Certification Fees: For EU MDR certification, similar products can be applied for jointly
• Logistics costs: The LCL service starting from 1CBM reduces the freight by 28% compared to FCL
• Planning of Tariffs: By taking advantage of the RCEP agreement, the tariffs on dental prosthesis components in China, Japan, and South Korea have been reduced to 3.8%
• Inventory Turnover: Establishing an overseas bonded warehouse can increase the response speed to emergency orders to 72 hours