On January 4, 2026, the National Medical Products Administration (NMPA) officially issued the Announcement on Adjusting Part of the Content of the Medical Device Classification Catalog (Announcement No. 132 of 2025, hereinafter referred to as the "Announcement"). This update optimizes the classification content for 31 types of medical devices, spanning 10 sub-categories including non-active surgical instruments, physical therapy devices, and dental instruments. The adjustments involve multiple dimensions such as changes in management classification, refinement of product descriptions, and clarification of intended uses. This move is an important step in implementing the Regulations on the Supervision and Administration of Medical Devices and the Working Procedures for Dynamic Adjustment of the Medical Device Classification Catalog. It aims to accurately align product risk with regulatory requirements, adapt to advancements in industrial technology and clinical needs, and is of great significance for ensuring public safety in medical device use and stimulating innovation within the industry. This article provides a comprehensive overview based on the official announcement and authoritative interpretations.
I. Policy Background: Why Dynamically Adjust the Medical Device Classification Catalog?
The classified management of medical devices is a foundational system for ensuring public safety and standardizing industry development. Its core logic is "risk-based regulation"—strict registration and approval management for high-risk products, and simplified filing processes for low-risk products. With the rapid iteration of medical technology, the diversification and upgrading of clinical needs, and the continuous accumulation of post-market risk data, some of the original classification criteria have become inadequate for accurately reflecting the actual circumstances of products. Dynamic adjustments have therefore become a necessary choice.
The core background for this adjustment primarily includes three aspects: First, technological advancement, as the application of new technologies like AI-assisted diagnosis and minimally invasive intervention has altered the risk profiles of some products, necessitating a redefinition of their classification attributes. Second, clinical demand guidance, as refining classifications and clarifying intended uses for frequently used devices in public diagnosis and treatment processes can enhance the standardization of clinical application. Third, regulatory efficiency optimization, as scientifically adjusting classification tiers allows for the concentration of regulatory resources on high-risk products while streamlining market access for low-risk products, achieving "precision regulation with a balance of delegation and control."
II. Key Adjustment Content: Four Major Changes for 31 Product Types
According to the Announcement and its annex, this adjustment covers 31 types of medical devices across 10 sub-categories. The core changes can be summarized into four main types, balancing regulatory precision and industry practicality:
1. Optimization of Management Classifications: "Downgrading and Reducing Burden" for Low-Risk Products, Precise Control for High-Risk Products
The most industry-focused aspect of this adjustment is the downgrading of management classifications for some products, effectively reducing corporate compliance costs and accelerating time-to-market. Typical adjustments include:
Class III downgraded to Class II: The product name example for "Delivery Introducers" is clarified as "Sterile Delivery Introducers for Single Use," and their management classification is lowered from Class III to Class II; "Ear Implants (e.g., Middle Ear Ventilation Tubes)" are listed separately, with their management classification also adjusted to Class II, simplifying the approval process while retaining necessary risk control.
Class II downgraded to Class I: The management classification for "Manual Wheelchairs" is lowered from Class II to Class I, bringing them under the filing management system. This is expected to further promote market supply of such rehabilitation aids, better meeting the needs of individuals with disabilities and the elderly.
It is noteworthy that this adjustment does not involve "upgrading" the classification of high-risk products. However, by refining the descriptions and intended uses of high-risk products, it strengthens the focus on their lifecycle regulation. For example, the material requirements and clinical application scopes for some implantable devices are specified to avoid regulatory gaps caused by ambiguous definitions.
2. Refinement of Product Descriptions: Eliminating Ambiguity, Unifying Regulatory Standards
To address issues of ambiguous definitions and interpretive discrepancies in previous classifications, this adjustment refines product descriptions and clarifies classification boundaries. For example, for "Accessories for Ultrasonic Therapeutic Equipment," descriptions for sterile products are added alongside the existing ones for non-sterile products. It is clarified that non-sterile products remain Class I, while sterile products are adjusted to Class II management. This covers actual clinical use scenarios while distinguishing risk levels.
Furthermore, for "Acupressure Stimulation Devices," the definition explicitly states they "do not exert therapeutic effects via infrared radiation or magnetic therapy, and do not contain pharmacological, immunological, or metabolically active ingredients," preventing confusion with therapeutic devices. "Gynecological and Obstetrical Medical Examination Pads (Non-sterile)" are specifically noted as "not intended for use as menstrual hygiene products," clarifying the boundary with general hygiene products and ensuring precise classified regulation.
3. Clarification of Intended Uses: Standardizing Clinical Use, Protecting Patient Rights
For some products, clarifying intended uses aims to prevent clinical misuse or off-label use. For example, for dental products like "Tooth Bleaching Agents," "Abrasive and Polishing Materials," and "Desensitizers," it is uniformly clarified that they are "not intended to replace toothpaste for daily teeth cleaning." Some of these products also require that they "should be operated by healthcare personnel with relevant qualifications." This standardizes clinical practices and guides consumers to correctly understand the product's positioning.
Such adjustments not only provide clear guidance for procurement and use by medical institutions but also reduce the risk of adverse events due to ambiguous product purposes, further ensuring patient safety.
4. Expansion of Product Name Examples: Adapting to Industry Innovation, Covering Emerging Products
By expanding product name examples, this adjustment incorporates some technologically mature and clinically common innovative products into the catalog's coverage, avoiding situations where products lack a classification. For instance, within the "Delivery Introducers" category, the previous example "Sterile Connectors for Single Use" is adjusted to "Sterile Delivery Introducers for Single Use," better aligning with the actual product forms used clinically and providing a clear basis for product registration by related enterprises.
III. Implementation Requirements: Transitional Arrangements for Registration and Filing
To ensure the smooth implementation of the policy, the Announcement specifies detailed implementation requirements and transitional rules, covering various scenarios such as new applications, applications under review, and already registered products, minimizing the impact on enterprise production and operations:
1. New Product Applications: Acceptance and Approval/Filing Based on Adjusted Classifications
From the date of the Announcement's release (January 4, 2026), medical product regulatory authorities will accept medical device registration applications or handle filing procedures based on the adjusted classifications according to regulations such as the Measures for Medical Device Registration and Filing. Enterprises must accurately prepare application materials in accordance with the adjusted catalog, ensuring product classification meets the latest requirements.
2. Products Already Accepted but Not Yet Approved: Continue Review Based on Original Classification, Note New Classification
For products whose applications were accepted before the Announcement's release but have not yet completed registration review and approval (including initial registration and renewal registration), regulatory authorities will continue to complete the review and approval process based on the original classification. For applications granted registration, a Medical Device Registration Certificate will be issued, with the adjusted product management classification noted in the remarks section, ensuring continuity of the approval process.
3. Already Registered Products: Transition Arrangements by Scenario, Remain Valid Within Validity Period
Class III downgraded to Class II: The registration certificates for already registered products remain valid within their validity period. For renewal registration, enterprises should apply to the corresponding regulatory authority as a Class II product according to the adjustment at least 6 months before the certificate expires. Upon approval, a new certificate will be issued under the new classification.
Class II downgraded to Class I: The registration certificates for already registered products remain valid within their validity period. Before the certificate expires, the enterprise must complete the product filing procedure with the relevant authority, transitioning from registration to filing.
Registration Changes: If a registered product undergoes a registration change within its validity period, an application should be submitted to the original registration department. If the original registration certificate was issued based on the old catalog, the adjusted management classification should be noted in the remarks section of the change approval document.
4. Regulatory Authorities: Strengthen Communication and Training, Ensure Comprehensive Regulation
The Announcement requires medical product regulatory authorities at all levels to strengthen the communication and training regarding the adjusted content, ensuring that regulatory personnel and relevant enterprise staff accurately understand the policy requirements. Concurrently, they must manage the transition between review and approval, filing, and post-market surveillance, ensuring policy implementation while strictly maintaining the baseline for public medical device safety.
IV. Policy Significance: Balancing Safety and Innovation, Promoting High-Quality Industry Development
This adjustment to the Medical Device Classification Catalog is an important measure by the NMPA to implement the "Four Stricts" requirements and deepen the reform of the medical device review and approval system. Its significance is reflected at three levels:
1. Ensuring Public Safety in Device Use: Precision Regulation to Reduce Risk
By refining product descriptions and clarifying intended uses, ambiguous areas in classification are eliminated. This prevents potential safety hazards in low-risk products due to overly lax regulation, while ensuring high-risk products are not under-regulated. The clarification of clinical uses also reduces the risk of product misuse, further safeguarding patient treatment safety.
2. Stimulating Industry Innovation: Reducing Burden to Unleash Momentum
The "downgrading" of some low-risk products simplifies the registration process and reduces compliance costs, particularly benefiting small and medium-sized enterprises, helping them allocate more resources to R&D and innovation. Simultaneously, the expansion of product name examples and clarification of classifications for emerging products provide a clear regulatory pathway for technological innovation, accelerating the translation of scientific and technological achievements.
3. Optimizing Regulatory Efficiency: Enhancing Modernization of Governance
The dynamic adjustment mechanism ensures the classification catalog accurately matches industry development and clinical needs, achieving an optimal allocation where "regulatory resources focus on high-risk products, and low-risk products have simplified management." This improves the focus and efficiency of regulation. Furthermore, the refinement of classification standards promotes the unification of regulatory standards, fostering a fair competitive market environment.
V. Industry Response Recommendations: Enterprises Should Focus on These Four Core Tasks
This adjustment has a profound impact on medical device manufacturers and distributors. Relevant enterprises should proactively adapt to the policy changes and focus on the following tasks:
Comprehensively Review Product Portfolio: Compare against the Announcement annex to verify all existing and in-development products, confirm if they are affected by classification adjustments, and clarify the new management classification and filing/registration requirements for each product.
Adjust Registration Application Strategy: For new product applications, prepare materials according to the adjusted classification. For applications under review or in-development products, communicate promptly with regulatory authorities to manage the transition.
Strengthen Internal Training and Communication: Organize training sessions for personnel in R&D, registration, quality, sales, and other departments to study the Announcement content, ensuring accurate implementation of new requirements across all processes and avoiding compliance risks due to misinterpretation.
Monitor Follow-up Policy Developments: Closely follow subsequent interpretation documents, training notices, and other key information such as classification inquiry channels released by the NMPA and local regulatory authorities. Proactively engage with regulatory needs.
Conclusion: Dynamic Adjustments to Become the Norm; Industry Must Adhere to the Dual Baseline of Compliance and Innovation
This adjustment to the Medical Device Classification Catalog is an important reflection of the continuous improvement of China's medical device regulatory system and signals that dynamic adjustments to the catalog will become the norm. As medical technology advances toward intelligent, personalized, and minimally invasive directions, the classification catalog will continue to evolve alongside technological innovation and clinical needs, achieving an organic balance between the "safety baseline" and the "development high line."
For the industry, it is essential to proactively adapt to policy changes, mitigating risks through compliant operations. At the same time, guided by policy, the focus should be on innovation and R&D centered on clinical needs, propelling China's medical device industry toward high-quality development in a high-end and internationalized direction. When using related medical devices, the public can check product classification and registration/filing information on the NMPA's official website to ensure the products used are legal, compliant, safe, and reliable.
Appendix: Official Policy Query Channels
Full text of NMPA Announcement No. 132 of 2025: https://www.nmpa.gov.cn/xxgk/ggtg/ylqxggtg/ylqxqtggtg/20260104173409116.html?type=pc
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