NMPA Party Leadership Group Conveys and Studies General Secretary Xi Jinping's Important Instructions and Reviews the Learning Campaign on Establishing a Correct View of Political Achievement

Key Takeaways

What happened: On 1 September 2026, the National Medical Products Administration (NMPA) convened an expanded meeting of its Party Leadership Group, combined with a meeting of its Party Building Work Leading Group, to convey and study the important instructions of General Secretary Xi Jinping, implement the arrangements made at the meeting of the Central Party Building Work Leading Group, summarise the NMPA's learning and education work on establishing and practising a correct view of political achievement, and set out how those outcomes will be consolidated and made routine and enduring.

Why it matters to industry: This is a governance and party-building announcement rather than a new technical device requirement. Nevertheless, it signals how China's drug and device regulator continues to frame its performance benchmarks: safety, efficacy and accessibility of products for patients, rectification of problems identified through central inspection, audit supervision and party-building assessment, and institutionalisation of effective working methods. Industry should treat it as directional context for the regulator's priorities, not as a new registration rule.

The notice channel publishes public information relating to medical device regulation, registration and post-market compliance. Companies should assess, against their own product classification, target-market registration pathway, technical documentation, labelling and instructions for use, quality management system and post-market maintenance arrangements, whether a given update affects existing or planned projects.

Source and Applicability

• Source organisation: NMPA, published through the CMDE notice and news channel
• Original publication date: 2 September 2026
• Meeting date reported: 1 September 2026
• Article type: Regulatory news
• Original source: https://www.cmde.org.cn/xwdt/zxyw/20260902084408101.html
• Applicability: Specific requirements are always governed by the latest formal publications of the competent regulatory authority.

The original publication states that this item was sourced from the website of the National Medical Products Administration.

Full Translation of the Core Content

NMPA Party Leadership Group Conveys and Studies General Secretary Xi Jinping's Important Instructions and Summarises the Learning and Education Work on Establishing and Practising a Correct View of Political Achievement

On 1 September, the NMPA held an expanded Party Leadership Group meeting and a meeting of its Party Building Work Leading Group to convey and study the important instructions of General Secretary Xi Jinping, implement the arrangements of the meeting of the Central Party Building Work Leading Group, summarise the NMPA's learning and education work on establishing and practising a correct view of political achievement, and study how to consolidate and expand the results of that learning and education work and advance the establishment and practice of a correct view of political achievement in a routine and enduring manner.

Comrade Huang Guo, Secretary of the Party Leadership Group and Commissioner of the NMPA, presided over the meeting and delivered a speech. Members of the NMPA leadership team and the responsible official of the discipline inspection and supervision group stationed at the State Administration attended the meeting.

The meeting noted that General Secretary Xi Jinping's important instructions fully affirmed the work and results of the learning and education campaign on establishing and practising a correct view of political achievement, and set clear requirements for consolidating and expanding its results and for establishing a long-term mechanism for a correct view of political achievement. The instructions are strongly political, ideological, targeted and guiding in nature.

It is necessary to study and implement General Secretary Xi Jinping's important instructions in depth, to continue studying and implementing his important expositions on establishing and practising a correct view of political achievement, to gain a deep understanding of the theoretical system and practical requirements of the correct view of political achievement, and to continuously strengthen the ideological and practical resolve to establish and practise it.

The meeting noted that, since the launch of the learning and education campaign, the Party Leadership Group and its directly affiliated party organisations have earnestly implemented the arrangements and requirements of the CPC Central Committee, stayed focused on the theme, grasped the key points, and continued to work hard on the integrated promotion of deep study, genuine investigation and practical rectification. They achieved quality in study, rigour in investigation and real results in rectification, and effectively resolved problems of deviation and dislocation in the view of political achievement within the field of drug regulation.

The national drug safety situation has remained generally stable; pharmaceutical research and development innovation and high-quality industrial development have advanced steadily; the people's diversified medication needs have been further met; and the correct view of political achievement has produced visible results across the drug regulatory system.

The meeting required that the results of the learning and education campaign be continuously consolidated and expanded, and that the campaign be made routine and enduring.

It is necessary to consciously benchmark against the correct view of political achievement in every link and aspect of drug regulation, and to make every effort to safeguard the safety, efficacy and accessibility of medicines for the public.

It is necessary to combine the problems identified through central inspection, audit supervision, party-building assessment and other channels, carry out rectification and remediation in depth, and genuinely translate learning outcomes into tangible results that drive high-quality development.

It is necessary to continuously improve institutions and mechanisms, and to make good use of and uphold the methods, systems and experience that proved effective during the learning and education campaign.

It is necessary to keep a firm grip on the imperative of safeguarding drug safety, to promote full and rigorous party self-governance in depth, and to provide a strong guarantee for writing the drug regulation chapter of Chinese-style modernisation.

Responsible officials of the member units of the NMPA Party Building Work Leading Group and the principal responsible officials of the departments and bureaus of the agency attended the meeting.

Page Context and Contact Details

The original page also carries the standard institutional navigation and footer of the Centre for Medical Device Evaluation (CMDE), covering sections such as institutional overview, information disclosure, regulatory documents, review science and the service hall, together with links to working dynamics, working notices, innovation and priority publicity, clinical trial implied许可 information, review status and master file registration publicity, as well as online services including the electronic submission platform, review progress enquiry, medical device product enquiry and classification enquiry.

• Address: Building 6, Zone 1, Courtyard 22 Guangde Street, Beijing Economic-Technological Development Area, Beijing, China
• Postal code: 100163
• Telephone (review business): 86452812, 86452813
• Telephone (acceptance and electronic submission): 88331776
• Website operator: Centre for Medical Device Evaluation, National Medical Products Administration
• Copyright: Copyright CMDE, all rights reserved; reproduction or mirroring without permission is prohibited.

AIMEILI Regulatory Interpretation

Read in isolation, this announcement is a party-building and internal governance item. Read within the broader regulatory context, it reinforces several themes that consistently shape NMPA and CMDE behaviour and therefore indirectly shape review expectations. First, safety, efficacy and accessibility remain the stated core objectives of regulation, which is reflected in the continuing emphasis on clinical evidence, risk management and post-market surveillance for medical devices. Second, the meeting explicitly links performance assessment to problems identified through central inspection, audit supervision and party-building assessment, and calls for in-depth rectification. In practice, that kind of language tends to accompany tighter internal quality control over review work, clearer documentation expectations, and greater attention to consistency and traceability of decisions. Third, the emphasis on institutionalising methods and mechanisms suggests continuity rather than abrupt change, which is favourable for companies seeking predictability in submission preparation.

From an international registration perspective, this type of notice should not be treated as ordinary industry news. A company should first determine what category the update belongs to: regulatory policy, guidance or standards, product approval, recall or safety communication, quality management system matters, or post-market supervision. Each category maps to a different internal action. If a company is running a registration project in an affected market, the update should be logged in the target-market regulatory tracking table, and the team should confirm whether it affects product classification, the registration pathway, the applicant entity, local representative responsibilities, or certificate maintenance arrangements.

For Chinese medical device manufacturers, the practical relevance of this item lies in documentation consistency and evidence-chain management. Companies should verify that current technical files, risk management reports, performance verification data, clinical evaluation or clinical evidence, labelling and instructions for use, quality management system certificates and post-market surveillance documents still support the latest regulatory expectations in the target market. Where an item touches safety notifications, recalls, product approvals or regulatory meetings, companies should also assess whether products of the same type, the same technical route or the same risk profile are likely to attract heightened reviewer attention.

Business Impact for Medical Device Companies

AIMEILI advises companies not to focus solely on the news item itself, but to determine whether the update affects product classification, technical documentation, labelling, the quality management system, post-market maintenance, or the registration strategy for target countries. Where specific products are involved, a documentation gap assessment should be carried out that takes account of the product's risk class and the requirements of the target market.

At the operational level, AIMEILI recommends three actions. First, record the official source link, publication date, applicable product scope and potentially affected areas in the regulatory tracking log. Second, have regulatory affairs, quality, research and development, and commercial teams jointly determine whether labelling, instructions for use, clinical evaluation, risk management or test reports need to be updated. Third, if the product is already marketed locally or a registration application has already been filed, assess in parallel whether the local representative, importer, distributor and after-sales team need to take communication, variation, supplementary clarification or post-market surveillance measures.

The value of this type of news is not simply knowing what a regulator has published, but converting public information into executable compliance actions. For companies preparing multi-country registrations, particular attention should be paid to the boundaries of document reuse between markets: the same CE, FDA, NMPA, ISO 13485 or MDSAP documentation may serve as core evidence in one country while requiring localised explanatory notes, translated labelling, authorised representative documentation or a post-market maintenance plan in another. AIMEILI recommends a short documentation gap review after every significant regulatory update, to avoid being caught off guard during deficiency response, variation or certificate renewal.

Documents to Review First

• Intended use and indications for use
• Basis for classification and the resulting classification conclusion
• ISO 13485 quality management system certification and related evidence
• Risk management file
• Performance verification and validation data
• Clinical evaluation or clinical evidence
• Labelling and instructions for use, including localisation status
• Authorisation documents and existing registration certificates

Common Risks

• Unclear or unsupported classification determination
• Incomplete evidence chains across technical documentation
• Labelling and instructions for use that have not been localised for the target market
• Unclear allocation of responsibilities for the authorised representative
• Insufficient post-market maintenance arrangements

Frequently Asked Questions

Can this NMPA announcement be used directly as a basis for a registration submission?

No. This article is intended for preliminary understanding and project assessment only. A formal submission must still be based on the latest requirements of the target country's regulatory authority, the classification conclusion for the specific product, and the company's own documentation. This announcement is a party-building and internal governance item and does not create or amend any medical device registration requirement, technical standard or review criterion.

What should companies do first after seeing such an update?

Start with a documentation gap assessment. Confirm whether the update affects the registration pathway, technical file, labelling, quality management system or post-market maintenance arrangements, and record the conclusion together with the source link and publication date in the regulatory tracking log so that the assessment is traceable at the next submission, variation or renewal.

Does this announcement change any requirement for device registration in China?

No. The announcement reports on the conveyance and study of leadership instructions and on the review of a learning and education campaign. It does not introduce, revise or withdraw any registration requirement, guidance document or technical review point. Companies should continue to monitor formal CMDE and NMPA publications for changes that do affect submissions.

Editorial Review and Scope of Application

• Author: AIMEILI Regulatory Editorial Team
• Professional review: AIMEILI Medical Device International Registration Project Team
• Sourcing principle: Priority is given to official regulatory authorities, international organisations, standards bodies and publicly available regulatory materials; industry media and project experience are used only as supporting references.
• Scope of application: This article supports preliminary understanding, documentation preparation and project planning. It does not replace the formal requirements of a target-country regulatory authority, testing conclusions or legal advice.

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