On June 1, 2026, the NMPA released two documents that strengthen its dynamic medical device classification system. The first is the “Classification Adjustment Announcement.” The second is the “Working Procedure for Dynamic Adjustment of the Medical Device Classification Directory.” Together, they establish a clearer, more scientific, and risk-based approach to adjusting product categories, management attributes, and risk classes. In practice, they define when a product qualifies as a medical device and how its classification may change over time.
Before reviewing the changes, three resources provide helpful context:
- the latest combination products classification results;
- the IVD classification catalog, effective January 1, 2025; and
- a continuously updated, searchable classification catalogue.
How the NMPA Dynamic Medical Device Classification Framework Works
The Working Procedure first defines when the directory may change. Specifically, five scenarios can trigger a classification directory adjustment:
- adding or deleting entire subdirectories;
- adjusting primary or secondary product categories;
- changing a product’s management class (Class I, II, or III) or its status as a medical device;
- revising product descriptions or intended uses; and
- updating nomenclature examples, such as adding representative products or removing items that no longer qualify as medical devices.
Who Can Propose an NMPA Classification Change
Notably, proposals may originate from several parties. For example, any of the following may submit a request:
- domestic and overseas manufacturers, although overseas firms must act through their Chinese agents;
- provincial medical product administration departments;
- industry associations and societies; and
- members of the NMPA Classification Technical Committee.
Each party files its proposal through the NMPA’s Center for Medical Device Standardization (CMDS) information system. Moreover, every submission must include detailed justifications.
Required Supporting Materials
To support a proposal, applicants must provide four items:
- an analysis of the product’s risks and any changes to its risk profile;
- its domestic and international classification status, together with relevant industry background;
- adverse event data and post-market surveillance information, where applicable; and
- a proposed transition period and the rationale behind it.
Provincial authorities conduct a preliminary review of local proposals before forwarding each one to CMDS.
Classification Transition Periods and Public Consultation
A key innovation of the revision is its clear, risk-based approach to transition periods. As a result, manufacturers can determine precisely how much time they have when a product’s class or device status changes.
General Transition Rules
- For an upward reclassification — for example, from non-device to Class II or III — the transition period is generally two to three years. Products that do not require clinical trials receive two years, while those that do receive three.
- For a more complex shift, such as from medical device to drug, the period may extend to five years, although it remains at least three years when longer registration timelines are expected.
When No Transition Period Applies
In certain cases, however, no transition period applies. This holds true in two situations:
- high-risk products that require immediate action to protect public safety; and
- products that the NMPA formally codifies into the directory once a classification consensus already exists.
Public Consultation on Classification Changes
The framework also incorporates public input. Accordingly, CMDS follows three consultation rules:
- It publishes proposed changes and transition periods on the CMDS website for at least 30 calendar days.
- For urgent public health needs, it may shorten the comment period to seven days.
- It may waive the comment period entirely once the NMPA has issued a final classification opinion.
After consultation, CMDS may reconvene the Classification Technical Committee to finalize the proposal. Finally, it submits the proposal to the NMPA for approval.
Detailed Registration Rules After Device Reclassification
The Classification Adjustment Announcement also provides manufacturers with concrete, step-by-step guidance for navigating the dynamic medical device classification changes. In practice, its key provisions fall into four groups.
For Existing Registration Certificates
- When the NMPA upgrades a product — for example, from Class II to Class III — the original certificate remains valid until the transition deadline. In the meantime, the manufacturer must apply for a new registration in the higher class.
- When the NMPA downgrades a product — for example, from Class III to Class I — the holder may transition to a filing process. At renewal, the new certificate must record the original registration number in the remarks section.
For Pending Applications
Pending applications frequently follow the previous class. Specifically, authorities may review any application accepted before the adjustment date under the earlier class. If they approve it, the new certificate must state the adjusted class. In addition, when a transition period applies, the certificate’s validity cannot extend beyond the transition deadline.
For Products Leaving the Medical Device Category
Some products lose their medical device status entirely. From the management attribute adjustment date, the NMPA no longer regulates them as medical devices. As a result, authorities terminate any pending applications and accept no new ones. Manufacturers should therefore cancel existing filings promptly; otherwise, the filing authority will cancel them publicly after the deadline.
For Production, Distribution, and Import
Finally, the rules tighten market access. After the transition deadline, every reclassified product must hold the appropriate registration or filing. Without that approval, a company may no longer manufacture, import, or sell it.
Important Clarifications from the Policy Interpretation
The accompanying interpretation addresses several practical questions. The three most useful points are summarized below:
- Effective dates: The “management category adjustment date” and “management attribute adjustment date” both refer to the implementation date stated in the NMPA’s announcement. Notably, neither refers to the registration or filing deadline.
- Special requests: When a manufacturer needs the original registration number to appear in the remarks field — for procurement or tendering, for example — the company must request this explicitly when filing the new application.
- Provincial responsibilities: Provincial NMPA branches must maintain a management ledger for affected products. They also supervise compliance and ensure that manufacturers meet their quality and safety obligations throughout the transition.
What the New Classification Rules Mean for Overseas Manufacturers
Overall, the NMPA’s dynamic medical device classification framework rewards organizations that plan ahead. Overseas manufacturers should therefore monitor each published proposal, review their product classifications regularly, and allow sufficient time for any transition. By acting early, they can keep their registrations valid and safeguard their access to the China market.