NMPA (CFDA) released very important regulations last month. Please see below NMPA Newsletter, covering government announcement, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in China.
Highlights
- Evaluation Points on AI-Aided Software
Four main considerations are listed for registration of AI-Aided Software.
- Electronic Regulated Product Submission (eRPS)
eRPS became effective on June 24, 2019.
27 Standards were issued in one day.
Policies
- NMPA issued the "Evaluation Points on AI-aided Software" on June 28, 2019. It contains four main considerations for the registration of AI-aided (deep learning infused) software:
- Needs analysis
- Data collection
- Algorithm design
- Verification and validation
To register AI-aided software and medical devices in China, before satisfying requirements of the Evaluation Points, the foreign manufacturers need to meet the requirements of Technical Review Guideline of Medical Device Software Registration and Technical Review Guideline on Medical Device Internet Security.
AI-aided software's safety and effectiveness lie in the quality and quantity of training, validation and test dataset. When developing products, manufacturers need to consider expanding the three datasets to include enough data from Chinese people, especially Chinese living in mainland China; to enhance the generalization ability of algorithm by diversifying datasets; to strictly control the collection, pre-processing, and labeling process of the datasets; must conduct risk analysis, risk control and documentation for the entire process. These may increase the workload and cost for overseas manufacturers.
At the same time, retrospective studies can be used for clinical evaluation of products with fewer safety concerns. It reduces the difficulty of clinical evaluation for manufacturers such as those develop diagnostics for rare disease.
- NMPA (CFDA) issued the "Notice on Implementation of eRPS for Medical Device Registration". The NMPA began to accept eRPS (http://erps.cmde.org.cn) as of June 24, 2019 but the paper submission is still available for the applicants.
The eRPS system affects product registrations including domestic class III, imported class III and class II medical devices and IVDs.
NMPA also published "Technical Guideline on Registration Material Requirements for Electronic Submission System" and "Notice on Folder Structure of Regulated Product Submission Table of Contents (RPS ToC)". Start from November 1, 2019 all registration material, no matter through E-submission or paperwork, shall be submitted as per the requirements from the two documents.
Guidelines
- NMPA issued three draft Medical Device Guidelines:
- Technical Guideline on Disposable Blood Perfusion Equipment (Draft)
- Technical Guideline on Raw Material Change Evaluation of Non-active Device (Draft)
- Registration Guideline on Extracorporeal Circulator for Cardiopulmonary Bypass System (Draft)
- NMPA issued four Notices of Soliciting Manufacturers' Opinion for following IVD guidelines:
- Registration Guideline on Blood Dialysis Equipment
- Technical Guideline on Toxicological Concern Threshold (TTC) in Leachable Safety Study
- Technical Guideline on Establishment and characterization of Unknown Leaching Evaluation
- Technical Guideline on Physical and Chemical Evaluation of Medical Devices
Standards
NMPA announced revisions of 27 Medical Device Industry Standards on June 6, 2019, involving multiple devices including Co-60 Teletherapy Unit, Infusion Sets with Precision Filters for Single Use and Automatic luminescence Immunoanalyzer, etc.
QA/Recalls/AEs
NMPA announced Recall Notices to 17 imported medical devices and IVDs:
Class I recall
- Beckman Coulter: Blood analyzer
Class II and III recall
- Medtronic: Porcine bioprosthesis
- Medtronic: Guiding catheter
- Roche: Treponema pallidum antibody detection kit
- Smith & Nephew: Negative-pressure wound therapy (NPWT)
- Bausch & Lomb: Soft hydrophilic contact lens
- Becton Dickinson: Infusion T-pump
- Gallini: Puncture biopsy needle
- Olympus: Electronic bronchoscope
- Ortho Clinical Diagnostics: ABO positive and negative stereotypes and RhD blood type matching card
- Biomet Orthopedics: Ultrasonic surgical equipment and accessories for joint revision
- Zimmer: Dental implants
- BioMerieux SA: N-terminal brain natriuretic peptide precursor assay kit
- William Cook: Embolization Coils
- Nobel Biocare: Abutment and screws for dental implants
- Cochlear Bone Anchored Solutions: Sound processor
- Air Liquide Medical Systems: Ventilator
New Approvals
- NMPA granted Innovative Device Status to four medical device manufacturers.
- Ethicon: Regenerated oxidized cellulose absorbs hemostatic powder
- Sequent Medical: Self-expanding aneurysm embolization system
- Kangfeng Bio-tech: Cardiac cryoablation system
- LifeTech Sci: Aortic stent graft rupture system
- NMPA granted Priority Approval Status to three IVD manufacturers:
- Bai-Care: Respiratory pathogen nucleic acid detection kit
- HotGen: Hepatitis B virus pgRNA (HBV-pgRNA) assay kit
- Sym-Bio Life Science: Non-derivatized multiple newborn genetic metabolic disease screening kit
If you have any thoughts or questions on the regulations, especially the AI guideline and electronic submission, please leave comments here or email me at gpalma@ChinaMedDevice.com.
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------