NMPA (CFDA) News Roundup 201909

The Monthly NMPA (CFDA) News Roundup covers government announcements, policies, standards, guidelines, QA/recall/AE, and new approvals in medical devices and IVDs in China. It is edited by ChinaMed Device, LLC (www.ChinaMedDevice.com), a consulting firm specializing in China NMPA (CFDA) regulatory affairs, CRO and market access services.

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Highlights:

• First Group of Unique Device Identification Devices

64 high risk implants as the first trial

• IMDFR Committee Members meeting

Two milestones to synchronize China with international PMS and clinical standards

• Guideline on Raw Material Change Evaluation of Non-active Device

6 aspects of guidance and 11 example devices

Policies

1. NMPA issued the First Group of Unique Device Identification Devices (Draft) on September 17. It specifies 64 Class III medical devices going into UDI implementation as the first trial. The devices include but not limited to:
   • Cryoablation needle and catheter
   • Absorbable suture
   • Guiding catheter
   • Balloon dilatation catheter
   • Cutting balloon
   • Thrombus aspiration catheter
   • Cardiac occluder delivery cable
   • Intravascular recovery device
   • Capsule endoscope system
   • ADSL filters
   • Implantable pacemaker
   • Implantable hearing device
   • Knee prosthesis
   • Hard brain (ridge) membrane patch
   • Endovascular prosthesis
   • Vascular Stent
   • Plastic filling material
   • Implantable access ports and accessories
   • Intraocular Lens

The document also provides the timelines for implementing UDI system for the first group of devices:From August 1, 2020, the medical devices produced shall have unique identifiers;

• Starting August 1, 2020, for initial registrations, the applicants shall submit the identifiers of smallest sales unit to the registration management system;
• Before August 1, 2020, for renewal and modification registrations, the applicants shall submit the identifiers of smallest sales unit to the registration management system;
• From August 1, 2020, before sales, the registrant shall upload the product identifiers and related data of the minimum sales unit and the higher-level package to the unique identification database.

For more info on the document, please click HERE.

2. International Medical Device Regulators Forum (IMDRF) Committee Members meeting was held on September 17-19. China became a member of the National Competent Authorities Report (NCAR) Exchange Program.

The NCAR Exchange Program is established to share medical device safety information among national regulatory agencies. Adverse incidents are evaluated and disseminated by members to prevent repetition of such incidents through the adoption of appropriate Field Safety Corrective Actions (FSCA).

According to final document developed by IMDRF, the following situations are required for info exchange:

• Events leading or highly likely to lead to unanticipated serious public health threat
• Observations from national trend analysis
• Request and share of information

The Committee Members meeting also passed the NMPA’s final proposal of “Medical Device Clinical Evaluation” The proposal was published on June 5, 2019 for

feedback and the final documents are now available on the IMDRF website: http://www.imdrf.org/consultations/cons-clinical-evaluation.asp.

For more info on the document, please click HERE.

Guidelines

1. NMPA published the “Guideline on Raw Material Change Evaluation of Non-active Device (Draft)”. The 25-page document guides manufacturers when non-active device raw material changes are made:
   1. Discussing design control
   1. Change control
   1. Basic Safety and Effectiveness List
   1. Evaluation pathways
   1. Implications on Device Master File
   1. Discussion of necessities to submit new registration or renewal registration

This Guideline also lists 11 devices as examples to demonstrate the necessity of submitting new/renewal registration:

• Hollow fiber hemodialyzer
• Facial implants
• Balloon dilatation catheter
• Vertebral fusion cage
• Orthopedic surgical tool handles
• Single use infusion set
• Absorbable suture
• Cornea contact lens solution
• Color contact lenses
• Acrylic bone cement for artificial joints
• Silicone rubber breast implant

For more info on Beijing IVD inspection, please click HERE.

2. NMPA published nine draft guidelines in September:

• Registration Guideline on 3D Printing Acetabular Cup (draft)
• Registration Guideline on 3D Printed Vertebral Body (draft)
• Registration Guideline on Quantitative Detection Reagent Performance Evaluation (draft)
• Registration Guideline on Tendon Ligament Fixation System (draft)
• Registration Guideline on Disposable Breast Positioning Wire (draft)
• Registration Guideline on Metal Intramedullary Nail System (draft)
• Registration Guideline on Qualititve Detection Reagent Performance Evaluation (draft)
• Registration Guideline on Metal Percutaneous Percutaneous Pacing Products (draft)
• Registration Guideline on Synchronized Cardioversion Products (draft)

QA/Recalls/AEs

NMPA announced Recall Notices for 17 imported medical devices in September:

Class I recall (the most serious):

• Edwards Lifesciences: Patient monitor

Class II and Class III recall:

• Boston Scientific: Pacemaker programmer/recorder/monitor
• Boston Scientific: Subcutaneous implantable cardioverter defibrillator
• Elekta: Robotic patient positioning platform
• Elekta: Radiotherapy planning system
• Medtronic: Rapid exchange balloon dilatation catheter
• Johnson & Johnson: Soft contact lens
• Olympus: Surgical energy system
• Intuitive Surgical: Endoscopic surgery control system
• Ortho-Clinical Diagnostics: Chloride ion dry film/ Lithium ion dry film
• Tecan: Multichannel sampler
• B.Braun: Absorbable suture with needle
• Medical Intelligence Medizintechnik: Patient positioning platform
• Howmedica: Knee prosthesis
• Nobel Biocare: Dental implants
• LivaNova: Cardiopulmonary bypass system
• Otometrics: Ocular electrogram

For English version of Measures for the Administration of Medical Device Recall, please email info@ChinaMedDevice.com. For our webinar on adverse, recall & overseas inspection, please click HERE.

New Approvals

1. NMPA granted Innovation Approval to Carbon Ion Therapy System, by Lanzhou Kejin Taiji Technology. It is the first domestic Carbon Ion Therapy System approved by NMPA.
2. NMPA granted Innovative Device Status to two manufacturers in September.
   • MicroPort: Endoscopic surgery system
   • Shenzhen Yuanxin Technology: Absorbable drug-eluting coronary stent
3. NMPA granted Priority Review Status to a manufacturer in September.
   • Beijing Xianruida: Drug-eluting peripheral balloon dilatation catheter

For slides on NMPA Regulatory Updates that we shared at RAPS Convergence 2019, please email info@ChinaMedDevice.com.

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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.