Beijing NMPA office published Beijing IVD (In Vitro Diagnostics) Inspection Plan on August 1, specifying the requirements in upcoming inspections, from today, August 16, to October 11, for all IVD manufacturers.

Focal Issues for NMPA IVD Inspection

Below are 13 points, mentioned in the Beijing NMPA IVD Inspection Plan, that manufacturers must check:

• Registration Certificate: if it manufactures without certificate
• Inspections in the past two years: if it rectifies all the defects
• Quality Management System: if it is well-established
• Manufacturing equipment, process equipment, inspection instruments: if they match the products and the scale produced, and ensure effective operation
• Supplier audit system: if it complies with “Guidelines on Suppliers Verification for Medical Device” and maintains effective operation
• Quality agreement with major raw material suppliers: if it clarifies the quality responsibilities of both parties
• Procurement records: if it meets the traceability requirements
• External procurement of standard products, calibrators, quality control products, production or quality control blood: if it meets the traceability requirements
• Mandatory standards and the technical requirements: if they are satisfied with registered or filed products
• Quality control procedures: if each batch of products has batch inspection records and meets traceability requirements
• Product manual and labeling: if it complies with relevant laws, regulations and standards
• Sale records: if they meet traceability requirements
• PMS system: if it implements a system for monitoring, analyzing and improving adverse events, and whether recalls are taken without potential safety hazards, and reports are made to relevant departments

China Med Device, LLC can help you with inspection gap analysis, onsite support during NMPA IVD inspection and address of open issues and communication of post-inspection, etc. We are also experienced in handing IVD products. For GMP inquiries or reference letters from IVD manufacturers, please email info@ChinaMedDevice.com.

Self-Audit and Reference

The Beijing NMPA IVD Inspection Plan specified that, from Aug 1-Aug 16, manufacturers have the opportunity for self-audit. They can conduct retrospective audit for the authenticity, based on the submission materials, and the Corrective Actions related to the previous inspection. The reference guideline is Good Manufacturing Practice Guidelines for Onsite Inspection of In Vitro Diagnostics.

IVD companies with large sales volume have been put into priority monitoring for which intensified and unannounced inspections can be expected.

The Beijing NMPA IVD Inspection Plan came after National NMPA’s 2019 Inspection Plan announced in March. National Plan involves following IVDs:

• Thalassemia gene detection Kit
• Ketamine detection kit
• Hepatitis B virus surface antigen detection kit
• Treponema pallidum antibody detection kit
• Cystatin C assay reagent
• Human chorionic gonadotropin test strip

For English version of reference guideline Good Manufacturing Practice Guidelines for Onsite Inspection of In Vitro Diagnostics, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.

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About ChinaMed Device, LLC 

ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.