With the widespread adoption of CAD/CAM technology in modern dentistry, dental zirconia blocks have become essential materials for dental laboratories and clinics.
For importers, understanding regulatory and documentation requirements before importing dental zirconia blocks is critical to ensuring smooth customs clearance and legal market access.
This article outlines the typical documents and approvals required by regulatory authorities when importing dental zirconia blocks.
In most countries and regions, dental zirconia blocks are regulated as dental materials or medical devices. Importers must first demonstrate that they are legally authorized to import and distribute such products.
Commonly required documents include:
Business License
Medical Device Distributor License or Registration (if applicable)
Tax Registration or Unified Business Identification Number
Import–Export Registration or Customs Filing
These documents confirm the importer’s legal status and eligibility to handle medical device products.
Depending on local regulations, dental zirconia blocks are usually classified as Class II medical devices or equivalent. Before importation, the product may need to be registered or notified with the competent authority.
Product name, model, size, and specifications
Intended use and indications
Device classification justification
Instructions for Use (IFU)
Product structure and material composition
Manufacturing process and quality control overview
Risk analysis and risk control measures
ISO 13485 Quality Management System Certificate
CE Certificate or FDA registration (if applicable)
Declaration of Conformity (DoC)
Performance and mechanical testing reports
Compliance with relevant standards (e.g. ISO 6872)
These documents demonstrate the product’s safety, performance, and regulatory compliance.
For each shipment, importers are typically required to submit the following documents to customs or relevant authorities:
Commercial Invoice
Packing List
Bill of Lading or Air Waybill
Certificate of Origin (COO)
Import Contract or Purchase Agreement
Import Declaration Form
Some regions may conduct document reviews or random inspections for medical devices.
For first-time imports or under enhanced regulatory control, authorities may request additional materials such as:
Product samples for testing or verification
Clinical evaluation reports or scientific literature (if applicable)
Interviews with the legal representative to verify business authenticity
Supplementary technical or test reports
These steps are intended to ensure product traceability, quality, and regulatory compliance.
Confirm local medical device classification requirements in advance
Coordinate closely with the manufacturer to ensure consistent documentation
Prepare complete and standardized English or local-language files
Allow sufficient lead time for first-time product approvals
Importing dental zirconia blocks involves more than logistics—it requires careful regulatory preparation and compliance with medical device regulations.
Well-prepared documentation not only helps avoid delays but also supports long-term, compliant market access.
As a professional dental zirconia block manufacturer, we support our partners by providing standardized technical documentation and regulatory support tailored to different markets, helping importers streamline the approval and import process.
