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China GSP On-Site Inspection Guideline Issued

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NMPA published the “Guideline for On-Site Inspection of Medical Device Supplier Quality Management (Draft)” on June 27, 2024. Feedback needs to be submitted by July 15, 2024.

Coupled with “Quality Management Measures for Medical Device Operations” taking effect on July 1, 2024, it will strengthen the GSP system by more strict inspection and ongoing supervision, and requirements on clear responsibilities, proper documentation, and the continuous training of personnel.

The on-site inspection document outlines the regulations and procedures for licensing, inspection, and oversight of medical device business operations in China.

We have experts and personnels dealing with issues such as centralized procurement, UDI system, internet sales, third-party logistics, and supply chain. Contact us at ino@ChinaMedDevice.com for more information.

Medical Device Business Licensing Site Inspection

1. Inspection Results:

  • Pass: All applicable items meet requirements or can be corrected on-site.
  • Rectification within a time limit: Key items (marked with “※”) non-compliance rate ≤10%, and general items non-compliance rate ≤20%.
  • Fail: Key items non-compliance rate >10%, or general items non-compliance rate >20%.

2. Rectification Process:

  • For “Rectification within a time limit” results, the enterprise must complete corrections within 30 working days and submit a report.
  • If the report is not submitted or corrections are insufficient, the authority will decide not to grant the license.

3. Key Item and General Item Compliance Calculation:

  • Key Item non-compliance percentage = (Number of non-compliant key items ÷ (Total number of key items – Number of justified exclusions)) × 100%
  • General Item non-compliance percentage = (Number of non-compliant general items ÷ (Total number of general items – Number of justified exclusions)) × 100%

Other Supervision and Inspections

1. Regular Supervision and Business Record Inspections:

  • Pass: All applicable items meet requirements or can be corrected on-site.
  • Rectification within a time limit: For items not meeting requirements.

2. Legal Compliance:

  • If an enterprise violates relevant laws or regulations, appropriate actions must be taken.
  • If violations affect product safety or efficacy, they must be addressed according to relevant articles of the Medical Device Supervision and Administration Regulations and the Medical Device Business Supervision and Administration Measures.

GSP Requirements

The draft document deliberates the details of on-site inspection requirements in tabular forms

QMS Establishment and Improvement:

  • Enterprises must establish a compliant quality management system suitable for their business scope and scale.
  • Encouraged to develop quality policies and objectives that meet legal and regulatory requirements.

Responsibilities and Systems:

  • Enterprises must ensure effective operation of the quality management system, with clear responsibilities for quality safety at all levels.
  • Conduct annual self-inspections and submit reports by March 31 each year.

Key Positions and Duties

Key Positions:

  • Key positions include the enterprise leader, quality leader, and quality management personnel, who must be equipped and qualified to manage quality effectively.

Duties:

  • Key personnel must manage quality documentation, ensure compliance with regulations, handle product complaints, manage recalls, and oversee the implementation of quality management policies.

Quality Records and Documentation

Quality Records:

  • Enterprises must maintain quality records covering all aspects of medical device operations, including supplier audits, purchase records, inspection records, storage, sales records, and complaint handling.

Documentation Management:

  • Quality management documents must be comprehensive, continuously updated, and reflect the enterprise’s actual operations.

Personnel and Training Requirements

Personnel Qualifications:

  • Enterprise leaders, quality leaders, and quality management personnel must be familiar with medical device regulations and possess relevant qualifications.
  • Quality leaders must have appropriate academic or professional qualifications and relevant work experience.

Training:

  • Ongoing training programs must be established for all personnel, ensuring they are well-informed about regulations and quality management practices.

Compliance and Record Keeping

Record Keeping:

  • Quality records must be accurate, complete, and traceable. Records of key activities must be maintained for specified periods, including permanently for implantable medical devices.

Use of Technology:

  • Enterprises are encouraged to use advanced technology for record-keeping to ensure data security and traceability.

Penalties

If the inspection reveals violations of the “Regulations on the Supervision and Administration of Medical Devices” or the “Measures for the Supervision and Administration of Medical Device Operations,” they should be handled according to law. If the non-compliant items found during the inspection are assessed by the drug regulatory department to affect or fail to ensure the safety and effectiveness of the products, they will be handled according to Article 86 of the “Regulations on the Supervision and Administration of Medical Devices” and Articles 22 and 24 of the “Measures for the Supervision and Administration of Medical Device Operations.”

For an English copy of the “Guideline for On-Site Inspection of Medical Device Supplier Quality Management (Draft)”, please email us at info@ChinaMedDevice.com. We charge nominal fees for the translation.

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