DentalGoodNews|Dental Credible Information Platform


New Medical Device Manufacturing Rules Countdown: 12 Months for Dental Device Firms

 
Issuing time:2025-11-20 18:34Author:Production & Research Dept.
Pro图文封面2025.png

试 读

2025年10月29日,国家药监局发布了《医疗器械生产质量管理规范》。这是十年来的首次全面修订,新的规定将在2026年11月1日正式施行,留给企业的适应期仅有12个月。

行业从野蛮生长到规范化的过程,伴随着法规的不断更新和完善,新的规范将填补过去的监管盲区。

新规的核心逻辑是从“检查合规”转向“主动履行质量安全责任”。企业不仅要关注产品的设计和生产,还需将风险管理贯穿整个质量管理体系。

新的要求强调了数字化转型的重要性,鼓励企业提高生产和质量管理效率,但同时也提出了更严格的合规门槛。

对于口腔器械行业而言,新的规定尤其重要,明确了委托生产的责任划分,要求企业建立双放行机制,确保产品上市的安全性和有效性。

随着新规的实施,企业面临的将不仅是挑战,还有提升自身管理水平的机遇……

本内容为【好的牙Pro】会员专属,点此加入会员解锁全文。

推荐文章

推荐文章

副标题

Member Trending Reads

Member Trending Reads

副标题

Full - mouth denture restoration is included in medical insurance. The industry concentration is at a low level, and there is huge room for integration. Are you ready to embrace new opportunities?
Regulation: Not to restrict growth, but to weed out bad apples & protect good ones—let quality firms shine in fair competition!
"Cooling Momentum, Unwavering Resilience" – The Dental Industry Is Marching Toward "Quality Restoration"!
California's New Bill Sets Clear Boundaries for Dentists' Decision-Making Authority: How to Balance Clinical Autonomy Amid the Capitalization Wave?
Mental Health: A Casualty of the Healthcare System — Who Foots the Bill for Practitioners’ Physical & Mental Well-Being?
National Dental Expansion Rebounds | 940 Net New (Sep)—What’s the Future Potential?
Standardized Implants → Millimeter-Level Orthognathic Bone Resection: Robots Reshaping Dental Surgery’s Execution Logic & Tech Boundaries!
【GOODNEWS】 Content for industry reference only (based on public info & professional judgment); not for decision-making. Readers bear full responsibility for their own judgment and risks. Copyright © This Platform. Unauthorized reproduction & commercial use prohibited. Errata, contributions & cooperation: Contact customer service via WeChat:HDSW_001
✉️
Subscribe to Our
Newsletter
We curate important stories and exclusive insights, delivered straight to your inbox.
In-depth analysis · Exclusive content · Fast-moving news
1
Contact Us


Cooperation & Contact: haodeya@dongxizixun.com
Industry Updates

Industry Updates

副标题