Monthly NMPA (CFDA) News Roundup covers government announcement, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by ChinaMed Device, LLC (www.ChinaMedDevice.com), a consulting firm specializing in China NMPA (CFDA) regulatory, CRO and market access services.
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2019 Standards Revision Plan
Help manufacturers with type testing and keeping in line with Chinese standards and international standards
Overseas Manufacturing Inspection Results
Some multinational companies are included
First innovation approval in 2019
Abdominal Endovascular Stent Graft is manufactured by MicroPort
- NMPA (CFDA) issued “2019 Medical Device Industry Standards Revision Plan” on March 20, in which 93 medical devices, IVDs were affected. It includes manufacturing methods, performance testing standards, biological evaluation, non-clinical standards, and quality systems of the 93 medical devices and IVDs.
Among the 93 revisions, unprecedented number of IVD standards are being established or revised:
- Standard on immunohistochemical reagent
- Standard on IVD testing systems – Performance evaluation methods – Part 1: Precision
- Standard on IVD testing systems – Performance evaluation methods – Part 2: Correctness
- Standard on sperm quality analyzer
- Standard on blood gas analyzers
- Standard on blood analyzer calibrator
- Standard on mass spectrometer – Part 2: Matrix-assisted laser desorption/ionization (MALDI) time-of-flight mass spectrometry
- Standard on Fluorescence immunochromatography analyzer
- Standard on Gram-negative bacterial lipopolysaccharide (bacterial endotoxin) assay kit
- Standard on Hepatitis B virus e antibody detection kit (chemiluminescence immunoassay)
- Standard on Amino acid and carnitine detection kit (tandem mass spectrometry)
- Standard on hereditary hearing loss gene detection kit
The Standards Revisions are aimed to facilitate manufacturers with local type testing and make standards more consistent with the international standards.
For our comments on the Standards Revisions, please click HERE.
- The draft proposal of “Medical Device Clinical Evaluation”, that NMPA submitted to the 13th International Medical Device Regulators Forum (IMDRF) management committee meeting, was approved by its stakeholders and members on March 21, 2019.
The draft proposal includes three guidance documents: clinical evidence, clinical evaluation and overseas clinical data. It is now available on IMDRF website: http://www.imdrf.org/consultations/cons-clinical-evaluation.asp
For our comments on the Clinical Evaluation proposal, please click HERE.
- NMPA issued six Clinical Trial Guidelines:
- Clinical Trial Guideline on Aortic Stent Graft System
- Clinical Trial Guideline on Bioabsorbable Coronary Drug-eluting Stents
- Clinical Trial Guideline on Transcatheter Aortic Valve
- Clinical Trial Guideline on Intraocular Lens
- Clinical Trial Guideline on Sodium Hyaluronate Facial Injection Filling Materials
- Clinical Trial Guideline on Ophthalmic Femtosecond Laser Treatment Machines for Corneal Flaps
- NMPA issued four Registration Guidelines:
- Registration Guideline on Human N-Terminal Pro-BNP Antibody
- Registration Guideline on Total Thyroxine Detection Reagent
- Registration Guideline on Progesterone Detection Reagent
- Registration Guideline on Procalcitonin Detection Reagents
- NMPA issued Notices of Soliciting Manufacturers’ Opinion for the following guidelines:
- Registration Guideline on 3D Printing Spinal Fusion Cage
- Registration Guideline on 3D Printing Acetabular Cup
- Registration Guideline on 3D Printing Artificial Vertebral Body
- Registration Guideline on 3D Printing Mandibular prosthesis
- Registration Guideline on Knee Prosthesis
- Registration Guideline on Metal Intramedullary Nail
- Registration Guideline on Finite Element Method for Orthopedic Metal Implants
- Technical Guideline on Virus Inactivation Verification Process for Allogeneic Implants
- Registration Guideline on Tendon Ligament Fixation System
- Registration Guideline on Dental Implant Abutment
- Registration Guideline on Dental Adhesive
- Documentation Guideline on Equivalence Model for Custom Bone Implants
- Documentation Guideline on Quality Control for Custom Bone Implant Interface
- Design Guideline for Hip Implant Fatigue Test
NMPA published Overseas Inspection Results on March 5, 2019. There are seven foreign medical device and IVD manufacturers were cited: Medtronic, Bausch & Lomb, DiaSorin, AL.CHI.MI.A., GELITA MEDICAL, PERMEDICA and SAMO.
- 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
Medtronic’s artificial 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.
Bausch & Lomb’s intraocular lens
There are two defects 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 our comments on the latest Overseas Inspection Result, please click HERE.
NMPA announced Recall Notices to ten imported medical devices and IVDs:
- Becton Dickinson: Vein Detained Needle
- Becton Dickinson: Blood Collection Tube
- Philips: Patient Monitor
- GE: ECG Cable
- Johnson & Johnson: Soft Contact Lens
- Beckman Coulter: Automatic Microbial Identification and Drug Susceptibility Analysis System
- Ethicon: Non-absorbable Polyester Suture
- B.Braun: Central Venous Catheter
- Covidien: High-Frequency Electrosurgical System Accessories
- Tosoh: Sample Diluent
- On March 20, NMPA granted Innovation Approval to abdominal endovascular stent graft, manufactured by MicroPort. It is the first Innovation Approval in 2019. The approval notice states “a CUFF stent graft can be placed at the proximal end of the stent graft or a branch stent graft can be placed at the distal end of the stent graft stent as an extension”, and in terms of the delivery system, “the ultra-fine outer diameter enables the stent system to easily reach the lesion through sharply curved blood vessels”
- There are total 50 domestic, 8 imported class III, 21 imported class II medical devices and IVDs approved by NMPA in February. GE, Becton Dickinson, Beckman Coulter, Covidien and Zimmer are on the list.
- NMPA granted Three Dimensional Laparoscopy System, manufactured by MicroPort, into Innovative Device Status.
For English version of Guideline on Innovative Device Approval Procedures, please email info@ChinaMedDevice.com.
For AdvaMed sponsored webinar on type testing in China, please email us also.
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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.