The NMPA released a notice “Announcement on Further Adjusting and Optimizing Matters Related to the Production of Imported Medical Devices in China” on 18 March, 2025. Building on the 2020 framework, the updates streamline processes for foreign manufacturers to produce Class II and III imported medical devices in China, aligning with the nation’s commitment to high-level openness and high-quality industry growth.
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China Med Device, LLC breaks down the policy’s core provisions and explores how global companies can leverage these changes to access China’s booming market.
Expanded Eligibility: Who Can Produce in China?
The document clarifies that foreign-invested enterprises (FIEs) eligible to produce imported devices in China now include two categories:
- Subsidiaries established by the overseas registrant** (the entity holding the imported device registration certificate).
- Affiliates sharing the same ultimate controller as the overseas registrant, as defined by China’s Company Law.
The term “ultimate controller” refers to any entity or individual capable of exerting decisive influence over a company through equity, agreements, or other legally binding arrangements. This flexibility allows multinational corporations (MNCs) to utilize existing corporate structures—such as regional headquarters or joint ventures—to localize production without restructuring global ownership.
Example: A German manufacturer of MRI systems can establish a wholly owned subsidiary in Shanghai or partner with a legally distinct Chinese affiliate under shared ownership to produce its NMPA-approved imported devices domestically.
Streamlined Registration: Reducing Redundancy, Accelerating Approval
A major hurdle for foreign manufacturers—duplicative documentation—has been addressed through three key simplifications:
- Reuse of Overseas Registration Data
Applicants may now submit original technical documents from their overseas registrations, including:
– Product summaries
– Non-clinical data (excluding safety/performance checklists and testing reports)
– Clinical evaluation reports
New requirements:
– Localized testing reports: Product specifications and test data must align with China’s mandatory standards (GB standards).
– Authorization letter: A notarized document from the overseas registrant permitting the use of its intellectual property (IP) and data for local production.
- Simplified Proof of Shared Control
For affiliates under the same ultimate controller, applicants must provide:
– A statement explaining the ownership relationship (e.g., equity structure charts).
– Supporting documents, such as the applicant’s latest annual report disclosing actual controller information.
- Priority Review for Innovative Devices
Innovative imported devices (as classified by China’s “Green Channel” criteria) qualify for expedited registration and production licensing—a strategic incentive to attract cutting-edge technologies.
Impact: The NMPA estimates these changes will reduce registration timelines by 40% for compliant applicants, accelerating market entry.
Harmonized Quality Management: Balancing Flexibility and Compliance
To ease the transition to local production while ensuring safety, the NMPA introduces pragmatic quality control measures:
- Core Process Consistency
Applicants must commit to using the same key raw materials and production processes as the overseas-registered product. Exceptions require detailed risk assessments and mitigation plans.
- Self-Certification with Verification
– Submit a self-assessment report confirming compliance with China’s *Medical Device Production Quality Management Practices.
– Provide a comparative analysis of domestic and overseas quality management systems (QMS), highlighting “substantial equivalence” in design and development processes.
Regulators will prioritize verifying QMS alignment during on-site inspections rather than demanding identical systems.
Long-Term Advantages
The 2025 updates also address post-approval processes to ensure sustainable operations:
- Simplified Post-Market Changes
Post-approval modifications (e.g., labeling updates, minor process adjustments) follow streamlined procedures under the *Medical Device Registration and Filing Management Measures.
- Domestic Entities as Registrants
Chinese companies investing in overseas registrants—or affiliates sharing their ultimate controller—can act as domestic registrants, enabling greater control over localized production.
Implementation Checklist for Overseas Manufacturers
China Med Device, LLC can help you access the China market utilizing the Made-in-China pathway:
- Assess Eligibility: Determine if your existing Chinese subsidiaries or affiliates qualify under the “same controller” rule.
- Audit Documentation: Identify your reusable overseas data and gaps in meeting China GB standards.
- Engage Notarization Services: Secure you a notarized authorization letter from the overseas registrant.
- Prepare QMS Reports: Help you conduct internal audits to align with China’s QMS requirements.