HONCHON Dental Zirconia Blocks Obtain SFDA MDMA Approval for the Saudi Market

We are pleased to confirm that HONCHON dental zirconia blocks have obtained Medical Device Marketing Authorization (MDMA) issued by the Saudi Food & Drug Authority (SFDA).

This approval authorizes the legal marketing, importation, and distribution of HONCHON dental zirconia materials in the Kingdom of Saudi Arabia.

SFDA MDMA Registration Information

HONCHON dental zirconia blocks are officially registered under the SFDA medical device regulatory framework.

• Issuing Authority: Saudi Food & Drug Authority (SFDA)

• Authorization Type: Medical Device Marketing Authorization (MDMA)

• Authorization Number: MDMA-2-2026-0110

• Product Category: Dental Zirconia Blank

• Intended Use: Zirconium oxide material for milling dental restorations

• Manufacturer: Changsha Honchon Technology Co., Ltd.

• Validity Period: January 2026 – January 2029

This authorization permits the approved products to be marketed for dental CAD/CAM applications, including crowns and bridges, in compliance with Saudi medical device regulations.

SFDA MDMA Registration Timeline

The SFDA MDMA registration process for HONCHON dental zirconia blocks was initiated in September 2025 and successfully completed in January 2026.

During this period, the SFDA conducted a comprehensive review covering product safety, quality management systems, technical documentation, and labeling compliance in accordance with Saudi medical device law.

Regulatory Documentation Submitted to SFDA

In line with official SFDA requirements for dental medical devices, the following documentation was submitted and evaluated as part of the MDMA registration process:

• Product Instructions for Use (IFU), packaging artwork, and labeling

• Latest product testing and performance reports

• ISO 13485 Quality Management System certificate

• Latest ISO 13485 audit report (English version)

• Product technical and marketing brochure

• Design and development documentation, including process validation records

All submitted materials were reviewed and accepted as part of the SFDA’s technical assessment.

Quality and Compliance Commitment

HONCHON operates under an ISO 13485–certified quality management system and applies controlled manufacturing and inspection processes throughout production.
The SFDA MDMA approval reflects our ongoing commitment to regulatory compliance, product traceability, and consistent material performance for dental laboratories and clinical applications.

Benefits for Partners in Saudi Arabia

For SFDA-licensed importers, distributors, and dental laboratories, MDMA approval enables:

• Legal market access within Saudi Arabia

• Smooth customs clearance and regulatory compliance

• Increased confidence when supplying approved dental materials

• Stable long-term product availability supported by regulatory authorization

Global Regulatory Strategy

The SFDA MDMA approval represents an important milestone in HONCHON’s international regulatory roadmap.
Alongside ISO 13485 certification and other global compliance initiatives, it supports our long-term goal of supplying reliable dental CAD/CAM materials to regulated markets worldwide.

Contact Information

For inquiries regarding SFDA-approved HONCHON dental zirconia blocks or cooperation opportunities in Saudi Arabia, please contact us:

• WhatsApp: +86 13055185196

• Email: info@honchon.com
   

Regulatory certificates and detailed SFDA registration documents can be provided upon request to SFDA-licensed importers, distributors, and regulatory authorities in accordance with applicable regulations.