China NMPA Allows Export Certificates for Unregistered Endoscopes, Ventilators

On May 1, 2026, China’s National Medical Products Administration (NMPA) implemented the Regulations on the Management of Medical Device Export Sales Certificates (NMPA Announcement No. 126 of 2025). This marks the first time that flexible videoscopes and ICU ventilators not registered in China may obtain an Export Sales Certificate (II) upon submission of a GMP compliance certificate. The change directly affects medical device exporters targeting overseas markets—particularly those developing innovative, export-only products—and signals a recalibration of regulatory pathways for international trade.

Event Overview

The NMPA’s Regulations on the Management of Medical Device Export Sales Certificates (Announcement No. 126 of 2025) took effect on May 1, 2026. Under this regulation, manufacturers may apply for an Export Sales Certificate (II) for certain unregistered devices—including flexible videoscopes and ICU ventilators—if they provide verifiable evidence of Good Manufacturing Practice (GMP) compliance. No domestic registration is required for these specific products to qualify for the certificate. The regulation is publicly confirmed and published by the NMPA.

Industries Affected

Direct Export Trading Companies

These companies often source or brand devices for non-Chinese markets without pursuing local NMPA registration. The new pathway reduces pre-export administrative friction: they can now support overseas regulatory submissions (e.g., FDA 510(k), CE technical documentation) with an official NMPA-issued certificate—even when the product lacks Chinese market authorization. Impact centers on faster documentation turnaround and strengthened credibility with foreign importers and regulators.

Contract Manufacturing Organizations (CMOs) & OEM/ODM Producers

Manufacturers producing flexible videoscopes or ICU ventilators exclusively for overseas clients—without intent to sell domestically—are now eligible to issue NMPA-backed export certificates. This lowers perceived risk for international buyers concerned about supply chain traceability and quality assurance. The main impact is enhanced commercial positioning, especially in competitive tenders where regulatory documentation is weighted heavily.

Supply Chain & Regulatory Support Service Providers

Firms offering GMP audit preparation, export documentation services, or regulatory strategy consulting will see increased demand for targeted support around Export Sales Certificate (II) applications. Unlike the standard Certificate (I), which requires full domestic registration, Certificate (II) hinges on GMP readiness—shifting service focus toward audit-readiness assessments and evidence packaging rather than registration dossier development.

What Relevant Enterprises or Practitioners Should Focus On

Monitor official NMPA guidance on scope and eligibility criteria

The regulation names flexible videoscopes and ICU ventilators as examples—but does not yet publish an exhaustive list of qualifying device categories or risk classifications. Enterprises should track subsequent NMPA notices or provincial bureau interpretations to confirm whether similar logic extends to other Class II/III devices intended solely for export.

Prioritize GMP compliance verification ahead of application

The regulation requires proof of GMP compliance, but does not specify whether third-party audits, provincial bureau inspections, or internal self-declarations suffice. Current practice suggests provincial-level NMPA offices conduct on-site verification; therefore, manufacturers should ensure facilities are audit-ready—including documentation control, process validation records, and personnel training logs—before initiating applications.

Distinguish between policy intent and operational rollout

While the regulation is effective as of May 1, 2026, provincial NMPA offices may vary in implementation speed, interpretation, and required supporting documents. Early applicants should treat initial submissions as pilot cases—documenting timelines, feedback, and procedural gaps—to inform internal SOP updates and cross-provincial strategy alignment.

Align export documentation workflows with certificate type

Export Sales Certificate (II) is not interchangeable with Certificate (I) in most overseas jurisdictions. Enterprises must verify whether importing countries accept it for customs clearance, reimbursement listing, or marketing authorization. Where acceptance is uncertain, concurrent pursuit of domestic registration—or dual-track documentation strategies—may remain prudent for high-priority markets.

Editorial Perspective / Industry Observation

Observably, this regulation reflects a pragmatic adjustment—not a broad deregulation—aimed at supporting China’s role as a global manufacturing base for innovative medical devices. Analysis shows the measure is best understood as a *procedural enabler*, not a de facto approval substitute. It lowers one barrier (domestic registration) while retaining another (GMP compliance), preserving regulatory oversight while improving export efficiency. From an industry perspective, the change signals growing recognition of divergent regulatory pathways across markets—and suggests future iterations may expand to additional device types or clarify equivalency with international GMP standards (e.g., ISO 13485 certification pathways). However, its immediate impact remains constrained to entities already operating under robust quality systems; it does not lower substantive safety or performance requirements.

In summary, the NMPA’s updated export certificate framework introduces a targeted, compliance-based route for unregistered flexible videoscopes and ICU ventilators—strengthening export readiness for qualified manufacturers without altering core quality or safety expectations. It is neither a shortcut nor a relaxation of standards, but rather a formalized acknowledgment of parallel regulatory realities. Currently, it is more accurately interpreted as a procedural signal—indicating regulatory flexibility for export-focused innovation—rather than an immediate, scalable solution across all device categories or markets.

Source: National Medical Products Administration (NMPA) Announcement No. 126 of 2025. Note: Eligibility extension beyond flexible videoscopes and ICU ventilators, as well as provincial implementation details, remain subject to ongoing observation.