NMPA published the final document of “Guideline for On-Site Inspection of Medical Device Operation Quality Management” on July 30, 2024. The draft was issued on June 27, 2024, for feedback.
Coupled with “Quality Management Measures for Medical Device Operations” taking effect on July 1, 2024, it will strengthen the GSP system by stricter inspection and ongoing supervision, and requirements on clearer responsibilities, proper documentation, and the continuous training of personnel.
The guideline applies to on-site inspections for and after the business licensing (including changes and renewals) of medical device operating companies as well as other types of supervision and inspection.
A medical device operating enterprise may determine not to include certain required items on the inspection list due to its different operation mode, business scope, and product range. They will need to provide a written explanation of the reasons of why they make these items not applicable to them. The decision will be confirmed by the inspection team of the drug supervision and administration department.
Our in-China local office team can perform on-site audit before local MPA offices knock on your door. We will review your post market approval quality system, its SOPs and perform actual on-site visits to see how your local entities are performing against the NMPA guideline requirements. Contact us at ino@ChinaMedDevice.com for more information.
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PART ONE
Guideline overview
The guideline aims to help enterprises establish a quality management system that meets regulatory requirements and ensures the quality and safety of products in medical device operations. The inspection content mainly includes the establishment and improvement of the quality management system, responsibilities and systems, personnel and training, facilities and equipment, procurement, receipt and acceptance, warehousing, reserve and inspection, sales, outbound and transportation, and after-sales service. Special emphasis was placed on the company’s responsibilities in the total post approval operation quality management, such as implementing quality and safety responsibilities, providing resource and system guarantees for services, and ensuring that personnel in key quality and safety positions effectively perform their duties. In addition, it also clarifies the conditions and requirements for quality management system documents, organizational structure, staffing, facilities and equipment that enterprises should have. The interpretation and application guide of the terms provide clear paths and methods for companies to conduct self-examination and rectification, aiming to improve the quality management capabilities and levels of medical device operating companies and protect public health and safety.
PART TWO
On-site inspection of medical device business license (including changes and renewals)
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 manufacturer 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%
PART THREE
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 the manufacturer 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.
PART FOUR
Main contents to be checked during on-site inspection
The guideline document provides the details of on-site inspection requirements in tabular forms, summarized as the following.
Chapter 1 Establishment and Improvement of Quality Management System
- License inspection: Check the business scope, business methods, management system documents, organizational structure, staffing, facilities and equipment.
- Supervision and inspection: Check license/registration information, management system documents, organizational structure, staffing, facilities and equipment.
- Personnel performance: Understand the familiarity and performance of personnel in key quality and safety positions through interviews, documents/records.
- Self-examination system: View the self-examination system, self-examination report, and self-examination report content.
- Continuous improvement: Check the establishment and update of management system documents and continuous improvement measures.
Chapter 2 Responsibilities and Systems
- Key positions for quality and safety: Check the job description or job responsibilities and verify the staffing.
- Person in charge of the company: Check the job responsibilities and verify the performance of duties.
- Quality manager: Check job responsibilities and verify duty performance.
- Quality management personnel: Check job responsibilities and verify duty performance.
- System: Check the buyer qualification review system, sales record system, cold chain medical device management system, direct transfer management system, etc.
Chapter 3 Personnel and Training
- Qualifications: Understand personnel qualifications through inquiries, surveys, academic qualifications/professional title certificates, etc.
- Training: View the training system, training records, training content, assessment records, and health files.
- Assessment: Check the assessment records to confirm whether on-the-job and regular assessments have been carried out.
Chapter 4 Facilities and Equipment
- Business premises and warehouse: Check the address, area, facilities and equipment, environment, and safety protection measures.
- Warehouse partition management: View partition settings, color mark management, and partition rationality.
- Facilities and equipment: Check isolation facilities, ventilation, moisture-proof, insect-proof and rodent-proof facilities, lighting equipment, packaging material storage places, and special equipment.
- Temperature and humidity control: Check the storage area/location settings, temperature and humidity monitoring equipment, and temperature and humidity setting range.
- Computer information system: View system functions, authority management, data management, information interaction, and data backup.
- Verification and Calibration: View facility equipment verification/calibration, measuring instrument calibration/verification.
Chapter 5 Procurement, Receipt and Acceptance
- Qualification review: Check the qualification review system, supplier files, product files, on-site inspection records, and report records.
- Procurement records: View purchase contracts/agreements, purchase orders, and purchase records.
- Direct adjustment management: Check the direct adjustment management system, direct adjustment product records, qualification review records, and record transfer certificates.
- Receipt management: View receipt records, accompanying orders, transportation methods, setting of areas to be inspected, and cold chain product processing.
- Acceptance management: View acceptance records, purchase inspection records, acceptance conclusions, and disposal records of unqualified products.
Chapter 6 Warehousing, Storage and Inspection
- Warehousing records: View the warehousing records and record contents.
- Storage management: View storage conditions, operating specifications, partition settings, equipment status, non-operator management, and non-related item management.
- In-warehouse inspection: View inspection records, record contents, and handling records of quality questionable products.
- Validity management: Check the validity management system, validity tracking and control, and disposal of expired products.
- Inventory: View inventory records, record contents, account and goods consistency, and problem handling records.
Chapter 7 Sales, Outbound and Transportation
- Sales staff management: View training files, authorization letters, and training content.
- Sales records: View sales records and record contents.
- Outbound review: View outbound review records, review conclusions, and disposal of unqualified products.
- Transportation management: View transportation records, transportation methods, transportation tools, transportation routes, and protective measures.
- Cold chain transportation: View cold chain transportation tool verification control documents, cold chain transportation records, temperature control requirements, refrigerated trucks/boxes/cabinets, calibration reports/verification reports/operating procedures.
- Entrusted transportation: View the entrusted transportation quality assurance agreement and assessment records.
- Emergency plan: View emergency plan and drill records.
Chapter 8 After-sales Service
- After-sales service system: Check the system, job responsibilities, and staffing.
- Technical services: View department settings, staffing, and office conditions.
- Complaint handling: View management regulations, staffing, complaint records, and handling records.
- Return management: Check the management system, return records, acceptance records, and disposal of unqualified products.
- Adverse event monitoring: Check staffing, report records, and cooperate with investigations.
- Recall management: Check the management system and recall records.
For an English copy of the “Guideline for On-Site Inspection of Medical Device Supplier Quality Management”, please email us at info@ChinaMedDevice.com. We charge nominal fees for the translation.
