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The National Health Commission revises five physician regulations; the National Medical Products Administration plans to standardize the evaluation pathway for AI-assisted diagnosis Medical Device Re…

 
Issuing time:2026-06-21 21:24Author:DentalGoodNews Editorial

National Health Commission Revises Five Physician Regulations: Free Clinic Filing System Implemented, Consultation Fees Must Be Paid Legally

On June 5, 2026, the National Health Commission (NHC) issued Decree No. 15, revising five regulations concerning physician practice registration, out-of-hospital consultations, free clinic filings, qualification examinations, and short-term medical practice in China by foreign physicians. The new regulations change the management of physician free clinics from an approval system to a filing system, delegate the approval authority for foreign physicians to the municipal-level health administrative departments, and clarify that medical institutions conducting consultations must legally pay reasonable compensation to the consulting physicians. This move unifies the framework for physician practice, consultation fees, and examination violation handling, enhancing regulatory efficiency.

National Medical Products Administration Proposes to Standardize Evaluation Pathways for AI-Assisted Diagnostic Medical Device Registration

On June 17, 2026, the Center for Medical Device Evaluation (CMDE) of the National Medical Products Administration (NMPA) released the "Guiding Principles for Clinical Evaluation Registration Review of AI-Assisted Diagnostic Medical Devices (Draft for Comments)." It specifies that AI-Assisted Oral Imaging Diagnosis products are classified as Class III medical devices and must provide clinical trial evidence. The guidelines require evaluation of diagnostic accuracy using metrics such as sensitivity, specificity, and AUC, and allow the reuse of trial data from the same company's existing algorithms. The document states that these products are only intended to assist physicians in diagnosis and cannot make independent decisions. Digital oral products, such as dental implant guides and customized orthodontic appliances, may also involve related software algorithms.

Jiangxi Announces Proposed Fees for Surgical Assistance Procedures: Intraoperative Microscopic Imaging Assistance at 300 Yuan per Procedure

On June 8, 2026, the Jiangxi Provincial Medical Security Bureau released new fee regulations for surgical assistance procedures. The fee for intraoperative microscopic imaging is set at 300 yuan per procedure, with an additional 60 yuan per procedure for swept-source optical coherence tomography. Fees for surgical robotic arms are divided into three tiers: navigation mode at 1,800 yuan per procedure (maximum 3,600 yuan), execution participation mode at 5,000 yuan per procedure (maximum 12,000 yuan), and precision execution mode at 16,000 yuan per procedure (maximum 26,000 yuan). Remote surgery assistance is charged at a 500% surcharge, with a maximum of 37,000 yuan. The fee for surgical navigation is 1,100 yuan per procedure, and micro-power assistance is 300 yuan per procedure, with no charge for disposable tools.

Jiangxi Proposes to Integrate 195 Oral Medical Service Items

On June 8, 2026, the Jiangxi Provincial Medical Security Bureau issued an announcement to integrate oral medical service items into 195 categories and publish unified pricing. The fee for a pulp vitality test is 5 yuan per tooth, jaw relation transfer examination is 420 yuan per procedure, and full-mouth periodontal system examination is 90 yuan per procedure. Additional charges for children are capped at 40.5 yuan per root canal, and additional charges for abnormal root canals are capped at 75 yuan per root canal. This integration includes 81 more items than the national guideline of 114 items, aiming to refine the charging standards for children and abnormal root canals, thereby improving fee transparency. The public comment period ends on June 22, and relevant parties can submit opinions in writing or via email.

WHOLE SHINE MEDICAL Faces Restored Enforcement of 362 Million Yuan

On June 5, 2026, the Shanghai Financial Court initiated restored enforcement against WHOLE SHINE MEDICAL TECHNOLOGY CO., LTD., involving an amount of approximately 362 million yuan. On the same day, the auditing firm issued a qualified opinion on its 2025 financial report, citing a lack of evidence for its 6.68% equity stake in Fushun Bank (book value of 431 million yuan). A 51% equity stake in its wholly-owned subsidiary, Delun Medical, was frozen by the court. In 2025, Delun Medical reported revenue of 638 million yuan, a year-on-year decrease of approximately 17.6%, and a net loss of 17.6013 million yuan. As of the time of this publication, WHOLE SHINE MEDICAL has disclosed relevant matters in its announcements; subsequent details are subject to official announcements.

Mitsui Chemicals Plans to Acquire Ultradent Products for $900 Million, Aiming to Become the World's Second-Largest Dental Materials Group

On June 12, 2026, Mitsui Chemicals America, a wholly-owned subsidiary of Japan's Mitsui Chemicals, announced plans to acquire all equity of U.S. dental product manufacturer Ultradent Products for approximately $900 million (approximately 6.094 billion yuan). Post-acquisition, the company is expected to become the world's second-largest dental materials group, with the Americas market revenue share projected to increase to 25%. The transaction is expected to be completed in September 2026, pending regulatory approval.

TOPCHOICE MEDICAL CORPORATION Proposes No Dividend for 2025: Retains Net Profit of 502 Million Yuan, Bets on Expansion in Optometry and Oral Hospitals

On June 26, 2026, TOPCHOICE MEDICAL CORPORATION will hold its 2025 shareholders' meeting. According to the disclosed meeting materials, the company reported revenue of 2.913 billion yuan and net profit of 502 million yuan for 2025, and decided not to distribute cash dividends. The company plans to invest 1.28 billion yuan in 2026, including 600 million yuan for acquiring four optometry companies and approximately 370 million yuan for oral project construction. It intends to repurchase shares worth 50 million to 100 million yuan at a maximum price of 60.12 yuan per share for cancellation. The company stated that in 2026, it will adopt a tiered pricing system to address market changes brought about by the VBP for dental implants, promoting a shift from single implant treatments to comprehensive oral lifecycle management for patients.

Sinocera Obtains Up to 700 Million Yuan Guaranteed Credit Line, Specifically for SDI Acquisition Project

On June 15, 2026, Shandong Sinocera Functional Material Co., Ltd., through its wholly-owned subsidiary InnoXvest, applied for a maximum joint and several guaranteed credit line of 700 million yuan from China Merchants Bank Shenzhen Branch, including 600 million yuan for acquisition loans and 100 million yuan for hedging credit. This is specifically for the full acquisition of Australian dental materials company SDI Limited at AUD 1.40 per share, with a total price of approximately 816 million yuan. The company has provided a maximum guarantee of 900 million yuan, accounting for 12.58% of net assets. The transaction still requires filing and approval from the Chinese and Australian governments.

Shining3D Tech Co., Ltd. Faces Second Round of IPO Inquiry: BSE Questions Overseas Growth Rationale, Gross Margin, and Overseas Subsidiary Losses

On June 12, 2026, Shining3D Tech Co., Ltd. released an IPO progress announcement, disclosing revenue of 1.575 billion yuan and net profit attributable to shareholders of the parent company of 425 million yuan for 2025, a year-on-year increase of approximately 100%. On June 11, the Beijing Stock Exchange (BSE) issued a second round of review inquiries to the company, focusing on verifying the reasons for its gross margin being higher than competitors such as Align and 3Shape, as well as the authenticity and reasonableness of rapid performance growth in mature markets like Europe and the United States. Issues related to overseas subsidiary losses were also raised. The company stated that due to the incomplete review process, its stock will continue to be suspended from trading.

Dental AI Platform Avora Secures 15.55 Million Yuan Seed Round Financing

On June 15, 2026, dental AI platform Avora completed a $2.3 million seed round financing in San Francisco, led by CRV, with participation from Y Combinator, Sequoia Capital, and Thrive. Founded in 2024, the company has deployed its AI document automation system in hundreds of dental practices, increasing case acceptance rates by 18% to 25% and saving each physician approximately 1.5 hours of documentation time daily. As of press time, Avora has not disclosed the specific use of funds, valuation, or closing timeline for this round.

Jianya Medical Receives Millions of Yuan in Seed Round Financing from Sailuo Medical

Recently, Hangzhou Jianya Medical Device Co., Ltd. completed a seed round financing of several million yuan, with a strategic investment from Sailuo (Changzhou) Medical Technology Co., Ltd. The funds will be used for the R&D and global market expansion of Jianya Medical's precision oral rotary instruments. Its products have entered over 150 countries and regions, with support from the Boston Investment Association. As of press time, Jianya Medical has not disclosed the valuation, equity ratio, or specific closing arrangements for this round of financing.

Canadian Dental Care Plan Demand Exceeds Expectations, 2026-27 Fiscal Year Budget Raised to 3.4 Billion Canadian Dollars

In June 2026, Health Canada announced that the benefit funding for the Canadian Dental Care Plan (CDCP) for the 2026-27 fiscal year has been raised to 3.4 billion Canadian dollars. Approximately 6.58 million people have been approved, with 4.47 million having received care. There are nearly 29,000 providers, and over 3.4 million renewals have been processed, but the pre-authorization approval rate is less than 50%. As of May 31, administrative costs were approximately 149 million Canadian dollars.

Scottish Dental Practice Costs Approach 70%, Private Sector Profits Rise by Approximately 23%

On June 17, 2026, the Scottish branch of the British Association of Professional Dental, Accountancy and Law (BAPDAL) released its report for the 2024-25 fiscal year. The average net profit for private dental practice partners rose to £253,200, a year-on-year increase of approximately 22.7%, while NHS practices saw a decline to £176,600, a drop of about 1.9%. The report indicates that total practice expenditure accounts for 68.1% of revenue. The average profit for associate dentists rose from £80,600 to £93,100, an increase of approximately 15.6%. The statistics are based on 2025 tax returns, as of April 5, 2025.

New Data: Approximately 9.6 Million U.S. Adults Have Sought Dental Care Abroad, Cost Disparity is the Primary Reason

In April 2026, the CareQuest Institute released a report titled "Cross-Border Care: Dental Tourism Among U.S. Adults," showing that approximately 3.9% (9.6 million) of U.S. adults have traveled abroad for dental treatment, with 58% choosing cross-border care due to lower costs. The report states that the average cost of root canal treatment in the U.S. is $838, which can drop to $542 or even $436 abroad, with potential savings of up to 75%. The sample size was 9,450 individuals, with a margin of error of ±1.61%.

New Approach to Periodontitis Management: Short-Term Caloric Restriction May Reduce Gingival Inflammation

Recently, a multicenter randomized controlled trial conducted by King's College London and other institutions showed that 28 periodontitis patients who underwent periodontal treatment and followed a 5-day simulated fasting diet (approximately 1,100 kcal for the first two days and 750 kcal for the last two days), repeated for three cycles, exhibited a downward trend in inflammatory markers in blood and gingival crevicular fluid during a 6-month follow-up period. The study did not observe significant differences in periodontal clinical parameters between the two groups, suggesting that the intervention primarily produced effects at the biomarker level. The team plans to conduct larger-scale studies to further evaluate its safety and potential benefits.

About DGN:DentalGoodNews (DGN) is a trusted professional media platform dedicated to the global dental industry. We deliver in-depth coverage of corporate news, policy & regulation, investment & funding, and clinical frontiers — serving dental institutions, device manufacturers, investors, and industry researchers worldwide. Contact us: haodeya@dongxizixun.com
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