As China's dental-care market surges, demand for imported high-end devices is expanding at an unprecedented pace. Yet, for domestic medical institutions and distributors, even when they already possess the relevantMedical DevicesOperating licenses, in the specialized field of "import," still face three core challenges:

1. Complex trade qualification barriers:?Not all business units possess these capabilities simultaneously.Import and exportRight.
2. Tricky cross-border fund settlement:?How can I safely and compliantly pay US-dollar invoices to overseas suppliers?
3. Stringent customs compliance procedures:?How should one address the special filing requirements for high-risk categories (such as Class III consumables)?

This article will be based on?Zhong Shen?Years of hands-on experience allow us to systematically break down the core process of importing dental medical devices and, more importantly, explain how we—as your professional trading partner—work in tandem with your business qualifications to jointly solve the challenges above.

I. The “First Threshold” for Imports: NMPA Classification and Qualification Requirements for Both Parties

The starting point of all work is to ensure that both the product and all participants possess the requisite legal qualifications. Under the Regulations on the Supervision and Administration of Medical Devices, oral medical devices are subject to classified management based on their risk level:

• Category I (Filing Administration):?Low risk, such as mouth mirrors and dental wax.
• Category II (Registration Management):?Moderate-risk items, such as clear aligners and dental handpieces.
• Category III (Registration Management):?They carry a relatively high risk, such as implants and bone-repair materials.

Key points:?There are two fundamental prerequisites for successful importation. First, the product itself must obtain the “Import Medical Device Registration Certificate” or filing certificate issued by the NMPA. Second,Regardless of how the import process is carried out, the final consignee within China (i.e., you, our client) must hold a Medical Device Operating License or filing certificate that matches the category of the imported products.?

II. Practical Import Clearance Process: Professional Division of Labor, Compliant and Efficient

With both parties fully qualified, we design a clear, compliant import pathway for you.

(I) Pre-filing Assessment—Details Determine Success or Failure

This is the pivotal step where we leverage our expertise to shield you from risk. We will conduct a comprehensive pre-assessment of HS-code classification, online verification of registration certificates, inspection and quarantine requirements, and more, leaving nothing to chance.

(II) Formal Import Declaration – Adopt the optimal solution based on product category

We will prepare and submit a complete set of rigorous declaration documents for you. The workflow varies slightly across product categories, yet the core objective remains the same—ensuring compliance and efficiency:

• For Class I and Class II medical devices:
  • Operating Mode:?Zhongshen International Trade can leverage our own import-export license and Class I & II medical device distribution filings to act as yourImport Agent ServicesandCustoms Declarant, we handle the entire international trade and customs clearance process for you. As the final consignee and end-user, you must provide your business license to customs to certify that you are legally qualified to receive and operate the goods.
• For Class III medical devices (such as implantable consumables):
  • Operating Mode:?For such high-risk products, we adopt the most rigorous “dual-title” customs declaration model recognized by customs authorities.
  • What is “dual-heading” customs declaration??This means at customsImport customs declarationOn the form, the names of both entities will appear simultaneously:Zhongshen International Trade (acting as the foreign-contracting, payment-settling, and customs-clearance-liable trade agent) and your company (as the domestically licensed consignee and operating entity)This model clearly delineates the legal liabilities of both parties, fully satisfies the customs authority’s oversight requirements for high-risk medical devices, and represents best practice for ensuring compliant importation of Class III products.

【Toresolve Capital Flow Challenges – The Core Value of Zhongshen International Trade】
No matter which declaration model is adopted, cross-border remittance remains a core challenge.

• Our solution:?Zhongshen International Trade will act as the external contracting and payment entity, signing the trade contract with your overseas supplier. We pay the USD貨款 to the overseas party on your behalf in full compliance; you simply remit the equivalent amount in RMB to us. This completely removes any cross-border fund-flow obstacles for you, making the transaction both safe and simple.

(III) Destination Inspection – Clear Allocation of Responsibilities

After the goods are released at the port, they will be transported to your company’s location. As the statutory operating entity, you must apply for inspection at the destination customs within 20 days. We will assist you in preparing the documents and coordinating communications throughout the entire process until the inspection is passed and the products are approved for market sale.

III. Common Import Issues and the Collaborative Solutions Offered by Zhongshen International Trade

All the issues below are drawn from real regulatory cases; the core of our solution lies in “coordination” and “prevention.”

1. Issue: No medical device registration certificate or operating license.
   • Preventive Measures of Zhongshen International Trade:?Our cooperation begins with qualification review. We will simultaneously verify the product’s NMPA registration certificate and your business license.Both parties must possess the required qualifications; otherwise, the project will not be initiated.?This is our reverence for regulations and our protection for clients.
2. Issue: The cargo information does not match the registration certificate information.
   • Preventive Measures of Zhongshen International Trade:?We will carry out a “three-party verification” with you. Before shipment, we will ask your side and our own to cross-check the nameplate data of the actual goods against the scope of your business license and the product’s NMPA registration certificate, ensuring 100 % alignment of critical information such as model and specifications.
3. Issue: Non-compliant Chinese labels and instructions.
   • Preventive Measures of Zhongshen International Trade:?We will provide you with the production standards for Chinese labels and instructions that comply with Chinese regulations in advance, and work with you to urge the overseas shipper to complete the rectification before shipment, eliminating such compliance risks at the source.

Conclusion: A strong alliance—choose a professional trading partner.

Importing oral medical devices is not simply a matter of “having a license”; it is a coordinated campaign of “professional division of labor and strong alliances.” You focus on specialized operations and market expansion in the medical field, while Zhongshen International Trade concentrates on solvingInternational trade qualifications, cross-border fund settlement, customs-compliant operationsThese three major challenges.

If you are a medical institution or distributor with legitimate operating qualifications and wish to optimize your import supply chain, please contact us. Let’s join hands to build a truly worry-free international supply chain.