2022-02-28-世界卫生组织-WHO_global_benchmarking_tool_plus_medical_devices_rev._VI+_MD_ver._1_–_Licensing_Establishments_47页_587kb

WHO GBT+Medical Devices: Licensing Establishments (LI) Summary

Core Content

The WHO Global Benchmarking Tool Plus Medical Devices (GBT+Medical Devices) outlines the regulatory framework for licensing establishments across the supply chain of medical products, including medicines, vaccines, blood products, and medical devices (including in vitro diagnostics, IVDs). The purpose of this function is to ensure that all facilities involved in the production, distribution, and sale of medical products are licensed and operate in compliance with Good Practices (GXP) or Quality Management Systems (QMS), depending on the product type.

Licensing is a fundamental regulatory activity that protects public health by ensuring the quality, safety, and efficacy of medical products. The National Regulatory Authority (NRA) is responsible for coordinating licensing and must be supported by legal provisions, regulations, and guidelines that empower it to issue, suspend, or revoke licenses. For medical devices, the licensing process may rely on self-declaration or third-party certification instead of mandatory regulatory inspections.

Main Points

1. Licensing Across the Supply Chain

• All premises, facilities, and companies involved in the supply chain (e.g., manufacturers, distributors, importers, exporters, and retailers) should have a license to operate.
• Licensing is based on compliance with GXP or QMS standards.
• The NRA must have the legal authority to issue, suspend, or revoke licenses.

2. Legal Framework

• A comprehensive legal basis is required to define the framework for licensing activities.
• Legal provisions should ensure that the NRA is empowered to enforce compliance with GXP/QMS and apply sanctions for violations.
• For medical devices, the legal framework may focus on QMS rather than GXP.

3. Post-Licensure Changes and Variations

• Legal provisions must require establishments to notify the NRA of any changes or variations to the initial license.
• These changes may affect the quality, safety, or efficacy of the products, and the NRA must assess them before approval.

4. Guidelines for License Applications

• Guidelines on the content, format, and procedure for license applications must be available and clear.
• The NRA should consistently apply these guidelines and maintain documentation of their implementation.

5. Qualified and Authorized Person

• Manufacturers must appoint a qualified and authorized person, and this designation must be approved by the NRA.
• Legal provisions should mandate this requirement and ensure that such individuals are recognized by the regulatory authority.

Key Information

Scope

• Applies to medicines, vaccines, blood products, and medical devices (including IVDs).

Maturity Levels and Rating Scales

Limitations and Remarks

• If there is no domestic manufacturing, the function does not apply to manufacturers but still applies to distribution practices.
• In some countries, regulatory inspections may not be required for certain establishments (e.g., distributors, retailers), and self-declaration or third-party certification may be used.
• For medical devices, the focus may be on QMS rather than GXP.
• License revocation may not always be the responsibility of the NRA; in such cases, close collaboration with other authorities is necessary.
• The publication and communication of guidelines to the target audience are as important as the guidelines themselves.

Evidence to Review

For each sub-indicator, the assessor should review the following:

• LI01.01: Published legal provisions for licensing based on GXP/QMS compliance.
• LI01.02: Legal provisions that empower the NRA to issue, suspend, or revoke licenses.
• LI01.03: Legal requirements for notification or approval of post-licensure changes.
• LI01.04: Guidelines on the content, format, and procedure for license applications.
• LI01.05: Legal provisions mandating the appointment of a qualified and authorized person by manufacturers.

References

1. Effective drug regulation: A multicounty study
2. National drug regulatory legislation: guiding principles for small drug regulatory authorities
3. WHO Global Model Regulatory Framework for medical devices including in vitro diagnostic medical devices
4. ISO 9001:2015 - Quality management systems
5. [ISO 13485:2016 - Medical Devices – Quality Management Systems – Requirements for regulatory purposes](https://www.iso.org/files/live/sites/isoorg/files/store/en/PUB100422 preview.pdf)

Conclusion

The licensing of establishments is a critical regulatory function that ensures the quality, safety, and efficacy of medical products. It is supported by a legal framework that mandates the NRA to issue, monitor, and enforce compliance with GXP or QMS standards. The GBT+Medical Devices tool provides a structured approach to evaluate the maturity level of licensing activities, ensuring that all relevant stakeholders are aware of and follow the established guidelines and procedures.