A particularly important clause is directly aimed at encouraging foreign participation—
“If a foreign registrant’s overseas parent group or its subsidiary owns a laboratory certified by a foreign government or by an internationally recognized laboratory accreditation body, and the laboratory is authorized by the parent group, the registrant may use that laboratory to conduct self-testing and issue the corresponding testing report.”
This clause is a game-changer for multinational companies. It allows overseas firms to leverage their in-house testing resources—such as labs already certified under ISO/IEC 17025 or accredited by regulatory agencies like the FDA or European Notified Bodies—to conduct regulatory testing for China submissions. This not only reduces time and costs associated with duplicative testing in China but also signals China’s openness to international standards and mutual recognition frameworks.
Applicability
This draft guideline primarily applies to scenarios where the applicant chooses to conduct self-testing instead of relying entirely on third-party qualified testing institutions. It is relevant for both routine and on-site testing organized by regulatory bodies and is also a valuable reference for enterprises establishing or refining their internal quality systems.
Key Requirements for Self-Testing
The guideline stipulates that all self-testing activities must be integrated into the manufacturer’s quality management system (QMS) in compliance with the Good Manufacturing Practices for Medical Devices (GMP) and related annexes. This integration ensures that testing results are reliable, accurate, and traceable. Applicants must establish a capable laboratory environment with appropriate personnel, equipment, and procedures. Additionally, any results submitted must originate directly from the applicant and be supported by well-maintained records and internal quality controls.
Regulators are expected to verify the self-testing capabilities of applicants during on-site audits. This includes reviewing human resources, laboratory facilities, sample handling, recordkeeping, quality controls, and environmental safeguards. For enterprises that already hold laboratory accreditations from recognized authorities (e.g., CNAS, CMA), or for products with simple or well-documented test requirements, only a document review may be necessary—reducing the regulatory burden.
Quality System and Risk Control Requirements
The applicant must establish a QMS aligned with Chinese regulatory standards and international best practices. Specific attention is given to the development of standard operating procedures (SOPs), risk management protocols, audit schedules, and continual improvement mechanisms.
Key components include:
- Annual internal audits and management reviews
- Staff training on regulations, testing methods, and data integrity
- Documentation and traceability for all laboratory activities
- Identification and control of risks and opportunities related to lab operations
- Handling of non-conformances with corrective and preventive action plans (CAPA)
Laboratory Infrastructure and Equipment
The guidance provides detailed specifications for laboratory infrastructure, particularly for specialized testing environments like:
- Clean rooms (e.g., particle-free, microbial-controlled)
- Electromagnetic compatibility labs
- PCR labs, pathology labs, and software testing rooms
Applicants must maintain equipment records, perform regular maintenance, verify calibration status, and ensure metrological traceability. Importantly, any instruments used must meet the technical requirements of the testing methods.
Sample and Data Management
Applicants are required to establish sample management procedures covering collection, storage, identification, and traceability. Any inconsistencies or deviations must be addressed with documented justifications. Raw data must be complete, legible, contemporaneously recorded, and securely archived. Any amendments must maintain a full audit trail to support regulatory transparency.
Quality Control Measures
To ensure data validity, applicants are expected to conduct both internal (e.g., staff cross-checks, blind testing) and external quality assessments (e.g., inter-laboratory comparisons, proficiency testing). Annual quality control plans must outline what tests are covered, frequency, methodology, and responsible personnel.
Delegation and Group Company Roles
While the default expectation is for the applicant to conduct testings, the document also allows for internal delegation under group structures. Specifically, a domestic applicant may authorize a subsidiary with CMA or CNAS accreditation to conduct self-testings. Similarly, for foreign applicants, as long as the testing is done in an appropriately certified lab within the corporate group and with proper authorization, the applicant may submit those testing results.
This is especially advantageous for multinational device manufacturers with global R&D or manufacturing centers. Rather than duplicating testing in China, they can consolidate compliance through existing accredited labs.
China’s draft Implementation Guideline for the Self-Testing Requirements of Medical Device Registration marks a significant step forward in both regulatory precision and international inclusivity. For overseas manufacturers, the provision that allows foreign accredited labs within corporate groups to conduct testing on behalf of the registrant opens a clear and efficient pathway into the Chinese market. It reflects China’s commitment to regulatory transparency, global standards, and innovation-driven access—qualities that make it an increasingly attractive destination for med-tech investment and expansion.
As this guideline transitions from draft to formal implementation, early alignment with its principles can help overseas firms navigate China’s regulatory landscape with greater confidence, speed, and strategic foresight.