Medical Device Registration Self-Testing Requirements Under New NMPA Draft Guide

The National Medical Products Administration (NMPA) has issued a new draft guide outlining detailed requirements for incorporating self-testing into the quality management systems of Class II and Class III medical device registrants, including those producing in-vitro diagnostic reagents, with a deadline for feedback set on July 11, 2025.

Evolution of the Regulatory Framework

Clear Scope and Responsible Parties

The guide applies to on-site inspections of self-testing for Class II and Class III device registrations and serves as a reference for applicants.
The registrant is the sole responsible party for the self-test report, regardless of who actually performs the testing.

Integration with Quality Management System (QMS)

Registrants must incorporate self-testing fully into their medical-device QMS, meeting China GMP and its annexes.
Self-testing is no longer an isolated activity but an integral part of the QMS.

Detailed Core Competency Requirements

Section 4, “Testing Competency Requirements”, forms the core of the inspection, systematically specifying personnel, facilities, environment, sample management, quality control, record control, method validation, etc.

Key Compliance Points for International Manufacturers

Responsibility Allocation Under Contract Manufacturing

Liability Connot By Delegated

Registrants may entrust their contract manufacturers in China to perform self-testing.
The final self-test report must be issued in the registrant’s name and bear its seal.
Contract manufacturers are strictly prohibited from subcontracting self-testing to any third-party laboratory.
The entrustment agreement must clearly define responsibilities for quality, sample consistency, document transfer (technical requirements, standards, SOPs) and result reliability.
Registrants must audit the contractor’s self-testing capability against all items in Section 4.1–4.7 and keep audit reports.

Conditions and Limits for Using Group Laboratory Resources

For international groups with global R&D and testing networks:

Domestic registrants may use laboratories owned by their domestic group companies or subsidiaries that hold CMA or CNAS accreditation. (Author's Note: In practice, this can be very difficult internationally because the China accreditations may conflict with other international accreditations.)
Overseas registrants may use laboratories owned by their overseas group companies or subsidiaries accredited by foreign governments or recognised accreditation bodies (e.g., ILAC-MRA signatories).
Prerequisite: Formal authorisation from the group is required, and the laboratory’s accreditation scope must explicitly cover the intended self-test items. The final self-test report is still issued by the registrant, with the group laboratory’s original test report attached.

Stringent Facility, Environment and Equipment Management

Special Environment Controls

Tests requiring cleanrooms, biosafety labs (BSL-2, BSL-3), PCR labs, EMC labs, constant-temperature/-humidity rooms, or IVD-dedicated labs must have detailed management procedures, environmental-monitoring records, and full compliance with relevant professional standards.

Equipment Management

Complete files are required (procurement, acceptance, SOPs, maintenance, repair, intermediate checks, calibration certificates and records).

Method Validation and Verification

Verification: Even when using international or national standard methods, laboratories must internally verify their ability to execute the method and obtain reliable results.
Validation: Self-developed methods, modifications to standard methods, or use outside the intended scope require full validation.
IVD-Specific Requirements: IVD methods must specify reference materials, controls, sample preparation, reagent batches/quantities, number of runs, calculation methods, etc.

Rigid Personnel Qualification and Record Requirements

Dedicated and Exclusive: Testing personnel must be formally employed full-time staff of the registrant and serve only that entity (evidenced by contracts, social-security records, etc.).
Competency and Authorisation: Educational background, technical competency and staffing levels must match testing requirements. Testing, reviewing and approving personnel must be formally authorised. Key posts have defined qualification and professional-title requirements.

Integration into China’s Regulatory Landscape and Key Changes

Shift from “Relying on Third Parties” to “Strengthening In-House Self-Testing Capability”: Emphasises that the registrant is the primary responsible party for product quality and that self-testing capability is a core component of its QMS and the fundamental guarantee of safety and effectiveness.
Shift from “Principle Requirements” to “Fine-Grained Management”: The guide provides extremely detailed and actionable inspection requirements, making regulatory expectations more transparent and specific.
Highlighting “Whole-Process” and “Traceability”: Unprecedentedly high requirements for whole-process control and traceability in sample management, testing, quality control and record retention.
Clarifying “Cross-Border” and “Entrusted” Responsibility Boundaries: Clearly defines the registrant’s ultimate responsibility in contract-manufacturing and group-resource scenarios, filling previous operational ambiguities.

Although this draft for comments shows encouraging signs about possibilities to avoid the often lengthy and practically difficult testing requirements in a NMPA certified test lab as part of the China approval process for devices and IVDs, the author’s expectation is still that the time saving will not be substantial for imported manufacturers even if the guidance is implemented.

Further Information

To read the original announcement about the draft “Implementation Guide for Self-Testing Management of Medical Device Registration” released by the NMPA, please click here.

If you are a medical device manufacturer with questions about the new self-testing requirements for registering your product in China, please contact Cisema.