NMPA (CFDA) published the latest batch of overseas inspection results on March 5. Seven overseas medical device and IVD manufacturers were cited:Medtronic, Bausch & Lomb, DiaSorin, AL.CHI.MI.A., GELITA MEDICAL, PERMEDICA, SAMOManufacturing facilities were located in the U.S, Italy, and Germany.
- Medtronic (U.S): Artificial Heart Valve
- Bausch & Lomb (U.S): Intraocular Lens (IOL)
- DiaSorin S.p.A. (Italy): IgM Antibody Detection Kit for Herpes Simplex Virus Type 1+2 and Hepatitis a Virus Antibody Detection Kit
- AL.CHI.MI.A. Srl (Italy): Perfluoronetane Solution for Ophthalmic Surgery, Perfluorocarbon-Filled Gas for Ophthalmic Surgery
- GELITA MEDICAL GmbH (Germany): Absorbable Hemostatic Gauze
- PERMEDICA S.P.A (Italy): Knee Prosthesis
- SAMO S.p.A (Italy): Cementless Artificial Hip Joint System
For Medtronic’s heart valve, the Result Report indicates the sanctuary issues of process water used for cleaning before packaging. Environmental Control Procedures and Water System SOP also failed to meet the requirements.
For Bausch & Lomb’s intraocular lens, two defects were identified in the manufacturing facility inspection in Florida: after hurricane period, the reviewing record failed to provide particle number, floating bacteria and sedimentation bacteria; the products were sent into cleaning room without proper purification.
For the detailed results with observations and penalties, please email info@ChinaMedDevice.com. ChinaMed Device, LLC, an NMPA (CFDA) certified legal agent, can also help you prepare NMPA (CFDA) overseas inspection with onsite training.
For RAPS post on NMPA (CFDA) overseas inspections, please see link Here.
For English version of Guideline on Overseas Inspection, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.
About ChinaMed Device, LLC
ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for western medical device, IVD, CDx and combination products to enter China. As a certified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent overseas manufacturers for the complete product life cycle without their need to set up local entity in China. Our NMPA (CFDA) regulatory services include: RA, regulatory strategy, regulatory submissions, clinical evaluation reports (CER), clinical trials, QA, GMP and post-market compliance. Our commercialization services include: market assessment research, reimbursement, partnership strategies, and distribution qualification.