The NMPA released two documents to enhance the dynamic management of medical device classification on June 1, 2026. Issued as “Classification Adjustment Announcement” and the “Working Procedure for Dynamic Adjustment of the Medical Device Classification Directory”, these updates establish a more scientific, transparent, and risk-proportionate system for adjusting product categories, management attributes (medical device vs. non-medical device), and risk classes.
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Adjustment Categories & Application Pathways
The Working Procedure specifies five scenarios that can trigger a directory adjustment:
1. Adding or deleting entire subdirectories.
2. Adjusting primary or secondary product categories.
3. Changing a product’s management class (Class I, II, III) or its status as a medical device (including clarifying ambiguous cases).
4. Revising product descriptions or intended uses.
5. Updating nomenclature examples (e.g., adding representative products or removing items no longer considered medical devices).
Proposals for adjustments can originate from multiple parties:
– Domestic and overseas manufacturers (overseas entities must act through their Chinese agents).
– Provincial medical product administration departments.
– Industry associations and societies.
– Members of the NMPA Classification Technical Committee.
These proposals must be submitted through the NMPA’s Center for Medical Device Standardization (CMDS) dedicated information system, accompanied by detailed justifications. Required supporting materials include:
– Analysis of product risks and risk changes.
– Domestic and international classification status and industry background.
– Adverse event data and post-market surveillance information (if applicable).
– Proposed transition period and rationale.
Provincial authorities are responsible for preliminary review of local proposals before forwarding them to CMDS.
Transition Periods and Public Consultation
A key innovation of the revision is the codification of clear, risk-based principles for setting transition periods when a product’s classification or medical device status changes.
General transition rules:
– Upward reclassification (non-device → Class II/III, or low class → high class): generally 2–3 years.
– 2 years for products not requiring clinical trials.
– 3 years for products requiring clinical trials.
– Complex shifts (e.g., medical device → drug): up to 5 years (minimum 3 years if longer registration timelines are expected).
– No transition period for:
– High-risk products where immediate action is needed to protect public safety.
– Products being formally codified into the directory after a classification consensus already exists.
Public consultation requirements:
– Proposed changes and transition periods are published on the CMDS website for at least 30 calendar days.
– For urgent public health needs, the comment period may be shortened to 7 days.
– No comment period is required if the NMPA has already issued a final classification opinion on the product.
After public consultation, CMDS may reconvene the Classification Technical Committee’s executive committee or relevant specialist groups to finalize the adjustment proposal before submitting it to the NMPA for approval.
Detailed Registration Rules
The Classification Adjustment Announcement provides concrete operational guidance for manufacturers during a classification shift. Key provisions include:
For existing registration certificates:
– If a product is upgraded (e.g., Class II → Class III), the original certificate remains valid until the transition deadline. During this period, the manufacturer must apply for a new registration in the higher class.
– If a product is downgraded (e.g., Class III → Class I), holders may transition to a filing process. When applying for renewal of a downgraded product, the new registration certificate must note the original registration number in the remarks section.
For pending applications:
– Applications for initial registration or renewal that were accepted before the classification adjustment date may be reviewed under the old class. If approved, the new certificate must specify the adjusted class and, if a transition period applies, limit the certificate’s validity to no later than the transition deadline.
For products ceasing to be medical devices:
– As of the management attribute adjustment date, the product is no longer regulated as a medical device. Any pending registration applications are terminated, and no new registrations or filings will be accepted. Manufacturers must proactively cancel any existing filings; otherwise, the filing authority will cancel them publicly after the transition deadline.
For production, distribution, and import:
– After the transition deadline, any product subject to upward reclassification or new device status must have obtained the appropriate registration or filing. Products without such approval cannot be manufactured, imported, or sold.
Important Clarifications from the Policy Interpretation
The accompanying policy interpretation document answers several practical questions:
– Effective dates defined: “Management category adjustment date” and “management attribute adjustment date” refer to the implementation date specified in the NMPA’s classification adjustment document – not the transition deadline for registration/filing.
– Special requests: If a manufacturer needs the original registration or filing number to appear in the remarks field (e.g., for procurement or tendering purposes), they must explicitly request this when submitting the new registration or filing application.
– Provincial authority responsibilities: Provincial NMPA branches must maintain a management ledger for affected products within their jurisdictions, supervise compliance, and ensure that manufacturers fulfill their quality and safety obligations throughout the transition.