NMPA Announcement No. 52 of 2026 sets new rules for registration, filing, renewals, amendments, and transition periods
China’s National Medical Products Administration has issued Announcement No. 52 of 2026 to clarify how medical devices, including in vitro diagnostic reagents, should proceed when their regulatory status or classification changes. The announcement addresses several common scenarios, including products reclassified from a higher-risk category to a lower-risk category, products moving from a lower-risk category to a higher-risk category, Class I filed products that must shift to registration, and products newly brought under medical device regulation. For manufacturers, registrants, filing holders, and importers, device classification is no longer only a technical catalog issue. It can directly affect the product’s market access route, certificate validity, filing status, transition-period obligations, and the legal ability to manufacture, distribute, or import the product in China. Regulix recommends that companies review their affected product portfolios, certificate expiration dates, filing status, and applicable transition deadlines as early as possible to avoid disruptions in China market access.
Initial registration must follow the adjusted classification
Under the announcement, any medical device submitted for initial registration after the effective date of a classification adjustment must be accepted and reviewed according to the adjusted product category. This means applicants should not rely solely on a previous classification when preparing a new registration submission.
For applications that had already been accepted before the classification adjustment date but had not yet received a final decision, the regulatory authority may continue the review and approval process under the original category. If registration is granted, the new classification should be noted in the remarks section of the registration certificate. If a transition period applies, the certificate validity should not extend beyond the end of that transition period.
For companies with pending submissions, Regulix recommends reviewing whether the product falls within the scope of the classification adjustment and whether the adjusted category may affect technical documentation, clinical evaluation, testing reports, or review expectations.
Existing certificate validity depends on the classification adjustment document
For products that already hold a medical device registration certificate, the announcement states that any special provisions in the relevant classification adjustment document should prevail. If no special provisions are provided, the requirements in Announcement No. 52 apply.
In practice, companies should not assume that all existing certificates will simply remain valid until their original expiration dates. For products subject to a transition period, certificate validity, renewal timing, and the subsequent registration or filing route may all be affected. This is especially important for products moving to a higher-risk category, where failure to obtain the required approval before the applicable deadline may create compliance risks for continued manufacturing, distribution, or importation.
Products moving to a lower-risk category may renew or file under the adjusted category
For products reclassified from a higher-risk category to a lower-risk category, if the existing certificate is approaching expiration and renewal is required, the registrant should apply for renewal or complete filing with the appropriate drug regulatory authority according to the adjusted category.
If renewal registration is granted, the authority will issue the certificate based on the relevant medical device classification catalog and the classification adjustment document, while noting the original certificate number in the remarks section. If the product qualifies for Class I filing after reclassification, and the filing materials meet the applicable requirements, the authority will complete the filing and note the original registration certificate number in the filing information form.
This pathway may reduce the long-term compliance burden for certain products. However, Regulix notes that a lower classification does not remove the need to maintain consistency across technical requirements, labeling, instructions for use, and quality management documentation.
Products moving to a higher-risk category must apply for registration under the new category
For products reclassified from a lower-risk category to a higher-risk category, the registrant must apply for registration with the appropriate authority according to the adjusted category. The announcement also clarifies that the validity of any certificate approved before the classification adjustment must not exceed the transition deadline specified in the relevant classification adjustment document.
For products that, due to technological development, are clarified as Class III medical devices, a previously approved Class II certificate may remain valid during its existing validity period. If the registrant has applied under the adjusted higher category during the validity period of the original certificate, but the original certificate expires before the transition deadline, the registrant may apply for renewal under the original category if the product remains safe and effective and has not been associated with serious adverse events or quality incidents after marketing.
If the original authority approves the renewal, the remarks section of the certificate should identify the adjusted product category, and the certificate validity must not extend beyond the transition deadline. Once the registrant obtains the certificate under the adjusted category, it should proactively apply to cancel the original certificate. If the registrant does not do so, the original registration authority will initiate the cancellation procedure.
Amendments for registered products generally go back to the original authority
The announcement also addresses amendments for registered products. For products that obtained a registration certificate before the classification adjustment date, as well as products that renewed under the original category after reclassification in accordance with the announcement, any required amendment registration or filing should be submitted to the original registration authority.
If the amendment is approved or filed, the authority will issue the relevant amendment document and note the adjusted product category in the remarks section. This approach helps preserve continuity in regulatory management, while reminding companies to explain the classification change clearly in amendment submissions.
Class I filed products moving to a higher category must apply for registration
The announcement provides specific rules for movement between filing and registration pathways. For products reclassified from a higher category to Class I, companies may complete Class I filing according to the adjusted classification from the date the classification adjustment takes effect. If an initial registration application had already been accepted before the adjustment date but had not yet received a decision, the applicant may either continue the registration process under the applicable rules or request termination of the review, with the submission materials retained for recordkeeping.
By contrast, if a Class I filed product is reclassified to a higher category, the filing holder must apply for registration with the appropriate authority under the adjusted category and proactively cancel the original Class I filing. If a transition period is provided and the filing holder does not cancel the filing by the transition deadline, the original filing authority will publicly cancel the filing.
This is a critical point for companies marketing Class I devices in China. Regulix recommends conducting a portfolio-level review of filed products to identify any devices that may be upgraded due to technology development, updated risk understanding, or classification catalog changes.
After the transition deadline, products without required approval or filing cannot be manufactured, distributed, or imported
The announcement makes clear that once the registration or filing transition period expires, products that have not obtained the required medical device registration certificate or completed Class I filing cannot be manufactured, distributed, or imported.
For products that were previously not regulated as medical devices but are newly adjusted to be regulated as medical devices, the applicant or filing holder must apply for product registration or complete Class I filing with the appropriate authority. After the transition deadline, products without the required certificate or filing cannot be manufactured, distributed, or imported.
For products adjusted from medical device management to non-medical-device management, the product will no longer be regulated as a medical device from the date the regulatory-status adjustment takes effect. Regulatory authorities will no longer process medical device filings or accept registration applications for those products. If an application had been accepted but not completed before the adjustment date, the authority should terminate the review and retain the application materials for recordkeeping.
Companies should build a classification-change compliance checklist
Announcement No. 52 shows that medical device classification changes are not limited to catalog updates. They affect registration strategy, filing status, renewals, amendments, manufacturing, distribution, importation, and post-market quality obligations. Registrants, filing holders, manufacturers, and importers should consider building a classification-change compliance checklist covering:
- Whether the product is affected by the latest classification or regulatory-status adjustment;
- Whether the existing certificate or filing remains appropriate;
- Whether the product is moving up, moving down, shifting from filing to registration, shifting from registration to filing, or leaving medical device regulation entirely;
- Whether a transition period applies and when it ends;
- Whether technical requirements, clinical evaluation, testing reports, labels, and instructions for use need to be updated;
- Whether pending submissions should continue, shift to a new pathway, or be terminated;
- Whether post-market quality and lifecycle management obligations remain fully implemented.
Regulix believes dynamic medical device classification adjustments will become a more routine part of China regulatory compliance. Companies should integrate classification review into early product planning, registration strategy, market authorization maintenance, and import compliance. Products involving borderline claims, innovative technologies, software algorithms, in vitro diagnostics, or combined-use features should receive particular attention to reduce registration delays and market access uncertainty.
