Beijing, China – 11 Sep 2026 – The Center for Medical Device Evaluation (CMDE), the technical review arm of China’s National Medical Products Administration (NMPA), announced an open public consultation on the “Guidance on the Registration Review of Service Life for Active Medical Devices (Revised Edition 2026) (Draft for Public Comment),” with stakeholder feedback due by 9 October 2026.
Regulatory Milestone
Item
Detail
Agency
CMDE, under NMPA (China)
Action Type
Open public consultation on draft registration review guidance
Document
Guidance on the Registration Review of Service Life for Active Medical Devices (Revised Edition 2026) (Draft for Public Comment)
Issuance Date
11 Sep 2026 (published online 14 Sep 2026)
Comment Deadline
9 Oct 2026, via email using the official feedback form
CMDE to review submitted comments and finalize the 2026 revised guidance
Guidance Profile & Regulatory Background
Revision Mandate: The revision was organized by CMDE in accordance with the NMPA’s standing program for the development and amendment of medical device registration review guidance documents, part of a broader, continuous modernization of China’s MedTech technical review framework.
Scope: The guidance governs how service life (use period) claims for active medical devices — devices that rely on electrical or other energy sources for operation — should be substantiated and evaluated during registration review in China.
Consultation Materials: Two attachments accompany the notice: the draft revised guidance (Attachment 1) and a standardized feedback form (Attachment 2), both downloadable from CMDE’s website.
Submission Channel: Comments and suggestions must be completed on the feedback form and emailed to the designated CMDE contacts before the 9 October 2026 deadline.
Compliance Relevance: Service life substantiation is a core component of registration dossiers for active medical devices in China; manufacturers, contract research organizations, and testing institutions should review the draft early and assess potential impacts on existing and planned registration strategies.
Industry Participation Window: Stakeholders have approximately four weeks to submit structured feedback — an opportunity for domestic and foreign MedTech companies to help shape review expectations before the guidance is finalized.
Regulatory Trajectory: The 2026 revision continues NMPA’s pattern of periodically updating technical review guidance to reflect evolving device technologies and international standards; the final version and its effective date have not yet been disclosed.
Pipeline Implications: Once finalized, the revised guidance will apply to new registration submissions for active medical devices and may influence how legacy service life claims are maintained or amended in post‑market regulatory activities.
Forward‑Looking Statements This brief contains forward‑looking statements regarding regulatory timelines, the finalization of the draft guidance, and its potential impact on medical device registration in China. Actual outcomes may differ due to risks including changes arising from the public consultation process, final agency determinations, and shifts in regulatory policy.-China Health Reform Pulse
Beijing, China – 13 Sep 2026 – Following the issuance of the revised “Five Measures” governing leaders of public institutions in the propaganda, ideological and cultural system, higher education, primary and secondary schools, scientific research institutions and public hospitals, officials of the Central Organization Department and the four co‑issuing departments – the Central Publicity Department, Ministry of Education, Ministry of Science and Technology and National Health Commission – answered reporters’ questions, detailing the revision’s background, guiding principles and sector‑specific provisions, including 5‑year experience thresholds for school and hospital leaders, mandatory full‑coverage training every five years, academic “inbreeding” recusal rules and rewards for technology‑achievement transformation.
Policy Milestone
Item
Detail
Issuing Bodies
Central Organization Department, jointly with the Central Publicity Department, Ministry of Education, Ministry of Science and Technology, and NHC
Documents
Revised Five Measures – management rules for leaders of public institutions in the propaganda/ideological/cultural system, higher education, primary & secondary schools, research institutions, and public hospitals
Announcement
13 Sep 2026 (Xinhua), accompanied by a press Q&A with officials of the five departments
Institutional Framework
The “1+5” system: 2015 provisional regulations → 2017 original Five Measures → 2022 revised Management Regulations → 2026 Five Measures revised for alignment
Revision Drivers
Alignment with the 2022 Management Regulations; new central requirements for sector reform; deepening public‑institution reform; resolving problems identified in practice and through inspection and disciplinary patrols
Drafting Principles
Problem‑oriented; sector‑specific (public‑interest, service, professional and technical characteristics); coordinated with recent cadre and sector policies; streamlined text
Political & Leadership Requirements
Party Leadership Codified: The general provisions explicitly require upholding and strengthening the Party’s overall leadership and Party management of cadres and talent; selection and appointment must give full play to the leading and gatekeeping role of Party organizations.
Gatekeeper Qualities: Party organization secretaries must be “politically strong, versed in Party building and professional work” with the ability to command the overall situation; execution of democratic centralism is emphasized in qualification conditions.
Political Standards First: Deeply comprehending the decisive significance of the “Two Establishes,” enhancing the “Four Consciousnesses,” fortifying the “Four Confidences” and upholding the “Two Safeguards” are established as the primary appointment requirement; political‑quality assessment is to be “deepened and solidified,” with sector‑differentiated examination priorities and strengthened political supervision.
Decision‑Making Mechanisms: Sector Measures require upholding and improving the administrative‑leader responsibility system under Party committee leadership, sound deliberation and decision‑making mechanisms, and explicit lists of decision items.
Sector‑Specific Professional Competence Thresholds
Propaganda/Ideological/Cultural System: Leaders must possess the theoretical level, professional knowledge and competence for their posts, and consciously strengthen “foot strength, eye strength, brain strength and pen strength.”
Universities: Leaders with teaching or research backgrounds should generally make up about half of leadership team members.
Primary & Secondary Schools: Party secretaries should generally have 5+ years of Party affairs or education management experience in the education system; principals should generally have 5+ years of education and teaching experience.
Research Institutions: Administrative heads and deputies in charge of operations should generally have experience in research management or research work in the relevant field.
Public Hospitals: Leaders should have 5+ years of medical and health work experience, or management experience in other relevant fields.
Appraisal, Exchange & Recusal System
Differentiated Appraisal: Performance evaluation stresses differentiation and targeting to make appraisal a genuine “command baton.” Sector emphases include ideological position management (propaganda system), teacher ethics and conduct (universities and schools), sci‑tech innovation capability, quality, effectiveness and contribution (research institutions), and linkage with public hospital performance monitoring to prevent profit‑seeking tendencies (hospitals).
Service‑Recipient Input: Appraisal methods emphasize soliciting opinions and evaluations from service recipients and optimizing procedures; specific ratios for annual “excellent” ratings of leadership teams and individuals are set to guide practice.
Leader Exchange (Rotation): Rotation requirements are tailored to optimizing higher‑education layout and regional resource allocation, balanced quality compulsory education and urban‑rural integration, and the expansion and downward extension of quality medical resources; rotation of highly professional leaders must leverage their expertise to prevent resource mismatch and talent waste.
Academic Recusal Rules: Addressing “academic inbreeding” in universities, research institutions and hospitals, leaders must recuse themselves from matters involving graduate students they directly supervise, their own academic teams and members, or other conflicts of interest that could affect impartial performance of duties; small or special‑circumstance schools in rural and remote border areas may apply tenure‑recusal rules flexibly according to actual conditions.
Incentives & Strict Management
Training: Sector‑specific training priorities are defined, with full‑coverage training of leaders in principle every five years; Party theory and spirit education anchor the curriculum.
Young Cadres & Composite Talent: Regular, standing mechanisms for cultivating and selecting excellent young cadres are required; schools and hospitals must build reserves of composite leaders strong in both Party building and professional work.
Income & Transformation Rewards: Normal wage growth and deeper income‑distribution reform are emphasized; university and research institution leaders may receive rewards for the transformation of scientific and technological achievements per regulations.
Autonomy & Care: Unit‑level political/administrative authority lists are to be refined to safeguard institutional autonomy, with strengthened positive incentives, humanistic care and attention to physical and mental health.
Strict Oversight: Strict observance of political discipline and rules is a basic appointment condition; selection enforces “five checkpoints” – political, moral, capability, work‑style and integrity; tenure systems, term‑objective responsibility systems and leadership‑transition handover requirements are refined; appraisal results serve as a key basis for team building, appointment, training, supervision, incentives and accountability; sector‑differentiated grounds for adjusting leaders unsuited to current posts (“able to go up and down”) are detailed.
Market Impact & Outlook
Public Hospital Governance: The 5‑year medical/health experience threshold, appraisal linkage to performance monitoring and explicit anti‑profit‑seeking language tighten the governance frame for public hospital leadership – relevant to hospital procurement behavior, KPI design and management stability.
Research Institution Leadership: Professional‑background requirements plus transformation rewards aim to professionalize research management while incentivizing commercialization of publicly funded science.
Education Sector Rotation: Targeted exchange rules for universities and schools support national goals of regional education balance and urban‑rural integration, with personnel implications for school leadership pipelines.
Effective Dates: Implementation timelines and transitional arrangements were not disclosed in the Q&A.
Forward‑Looking Statements This brief contains forward‑looking statements regarding the implementation of the revised Five Measures for public institution leadership management, including appointment practices, appraisal systems, exchange and recusal enforcement, and incentive mechanisms. Actual outcomes may differ due to risks including sector‑level implementation guidance, institutional practices, and subsequent policy adjustments by the relevant authorities.-China Health Reform Pulse
Beijing, China – 13 Sep 2026 – The Organization Department of the CPC Central Committee (Central Organization Department), jointly with the Central Publicity Department, the Ministry of Education, the Ministry of Science and Technology and the National Health Commission (NHC), has revised and issued the “Five Measures” – sector‑specific management rules for leaders of public institutions across the propaganda, ideological and cultural system, higher education institutions, primary and secondary schools, scientific research institutions and public hospitals – completing the alignment of the “1+5” institutional framework with the 2022 revised Regulations on the Management of Leaders of Public Institutions.
Policy Milestone
Item
Detail
Issuing Bodies
Central Organization Department, jointly with the Central Publicity Department, Ministry of Education, Ministry of Science and Technology, and NHC
Documents
The revised “Five Measures”: Management Measures for Leaders of Public Institutions in the Propaganda, Ideological and Cultural System; of Higher Education Institutions; of Primary and Secondary Schools; of Scientific Research Institutions; of Public Hospitals
Announcement Date
13 Sep 2026 (Xinhua)
Institutional Framework
Completes alignment with the 2022 revised Regulations on the Management of Leaders of Public Institutions (the “1” in the “1+5” system)
Historical Lineage
2015: Central Committee General Office issued provisional regulations; 2017: original Five Measures issued by sector; 2022: regulations revised; 2026: Five Measures revised to match
Objective
Provide stronger institutional guarantees for building a high‑quality, professionalized leadership workforce in public institutions
Key Provisions of the Revised Five Measures
Strengthened Party Leadership: The revision enforces the requirement of upholding and strengthening the Party’s overall leadership, emphasizing Party management of cadres and talent, the leading and gatekeeping role of Party organizations, and improved Party leadership systems and mechanisms.
Political Requirements First: Political standards are placed at the forefront of leadership appointments – deeply comprehending the decisive significance of the “Two Establishes,” enhancing the “Four Consciousnesses,” fortifying the “Four Confidences” and upholding the “Two Safeguards” are defined as the primary requirements for taking office, with deeper political‑quality assessment and strengthened political supervision.
Professional Competence Mandate: The Measures set explicit requirements for relevant professional backgrounds or professional work experience, tailored to the realities of each sector and the demands of each post – a professionalization signal for hospital, university and research institute leadership.
Correct Performance View: Term objectives stress laying foundations, benefiting the long term and seeking real results; performance appraisal content is refined, with targeted requirements to prevent and correct deviations in the view of political achievements.
Positive Incentives: To energize public institutions, the Measures emphasize strengthened positive incentives and humanistic care for leaders.
Strict Oversight & Mobility: Supervision priorities are clarified for key sectors and links, and sector‑specific scenarios are detailed for promotion and demotion (“able to go up and down”) of leaders.
Regulatory Context & Market Impact
Public Hospital Governance: With the NHC co‑issuing the hospital‑specific Measures, public hospital leadership selection, appraisal and supervision now operate under tightened, standardized rules – reinforcing Party committee leadership under the principal‑responsibility system for hospital administration.
Research & Innovation Institutions: For scientific research public institutions, professional‑background requirements and performance‑view corrections aim to de‑emphasize short‑term metrics in leadership evaluation, with implications for how research organizations are run and appraised.
Education Sector Coverage: Separate Measures for universities and for primary/secondary schools recognize the distinct governance patterns of each tier, extending cadre‑management discipline across the full education system.
Institutional Consistency: The revision resolves inconsistencies between the 2017 sector Measures and the 2022 revised umbrella Regulations, closing a four‑year alignment gap in the “1+5” system.
Implementation Details: Effective dates, transitional arrangements and sector‑level implementation guidance were not disclosed in the announcement.
Forward‑Looking Statements This brief contains forward‑looking statements regarding the implementation of the revised Five Measures for public institution leadership management. Actual outcomes may differ due to risks including sector‑level implementation guidance, cadre appointment and appraisal practices, and subsequent institutional or policy adjustments by the relevant authorities.-China Health Reform Pulse