CFDA News Roundup 201902

China 1.2 Billion registered cell phone users: CFDA Mobile Medical Device Technical Review Guideline Announced
January 30, 2018
Common Errors in Writing NMPA IVD Clinical Protocol
April 22, 2019

CFDA News Roundup 201902

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.

Keep yourself updated with NMPA (CFDA) News Roundup, click HERE to opt-in.

 

HIGHLIGHTS

  • 2019 Registration Guidelines Revision Plan

Assists manufacturers with product registration and keeping in line with international guideline

  • Opinion wanted

NMPA solicits feedback and input from IVD and medical device manufacturers on upcoming revisions (guidelines)

  • Clinical Trial Audit Results (2016 – 2018)

Common issues NMPA is pursuing

POLICY

On February 25, 2019 NMPA announced the 2019 Medical Device Registration Guidelines Revision Plan including 86 medical devices, IVDs and documentation methods.

The Guidelines Revisions aim to facilitate manufacturers with product registration and streamlining the guidelines with their international counterparts (with international guidelines).

The plan also states that NMPA offers the opportunity for (encourages) related manufacturers, industry associations and research institutions to contribute their opinions to the revisions of the guidelines.

The plan covers:

Active Device

Endoscopy electrosurgical unit, endoscopy for gastrointestinal tract, X-ray computed tomography (CT) system, artificial intelligence (AI)-aided medical device, non-invasive transcutaneous pacing, implantable and non-implantable magnetic resonance device, dental digital impression instrument, home-use pulse oximeter, etc.

Non-Active Device

Bioresorbable polymer drug-eluting coronary stent, balloon dilatation catheter, knee replacement, dura mater patch, Intraocular lens, orthokeratology corneal reshaping lens, metal intramedullary nail, firm embryo transfer catheter for assisted reproduction, fallopian tube catheter, facial prosthesis, etc.

IVD

Hepatitis B virus E antigen and E antibody detection reagent, Thalassemia gene detection reagent, Dengue virus nucleic acid detection reagent, EB virus nucleic acid detection reagent, Rheumatoid factor (Rf) detection reagent, home-use IVD, etc.

Documentation Methods

Prior approval supplements guideline, guideline on digital submission of registration documents (draft).

The Plan includes five 3D printed devices: 3D printed spine fusion cage, acetabular cup, spinal implants, bone implants and mandible.

For our post on the Registration Guidelines Revision Plan, please click HERE.

GUIDELINE

  1. On February 1, 2019 NMPA issued the Draft Guideline on Artificial Intelligence (AI)-based Diagnostic Software, soliciting feedback. Feedback needs to be submitted to NMPA by March 31, 2019.

The draft guideline lists four main considerations for registration:

  • Needs analysis
  • Data collection
  • Algorithm design
  • Verification and validation

All diagnostics are newly added to the Medical Device Classification Catalog effective August 1, 2019.

 

  1. NMPA issued Notices of Soliciting Manufacturers’ Opinion for following IVD guidelines:
  • Guideline on Technical Review of IVD Registration Renewal
  • Guideline on Hepatitis B Virus Gene Mutation Detection Reagents
  • Guideline on EB Virus Nucleic Acid Detection Reagents
  • Guideline on Performance Evaluation on Quantitative Testing Reagents
  • Guideline on Performance Evaluation on Qualitative Testing Reagents

QA/RECALL

  1. NMPA issued the Clinical Trial Audit Results 2016-2018. Number of clinical trials identified with issues in the years
  • 2016: 8 out of 20
  • 2017: 3 out of 19
  • 2018: 9 out of 10. The results of additional 10 trials have not yet been announced.

NMPA also summarized 10 categories of common issues found in clinical trial audits.

For our post on Clinical Trial Audit Results 2016-2018, please click HERE.

  1. NMPA announced recall notices to 10 imported medical devices and IVDs:
  • Medtronic: Program controller
  • Medtronic: Cranial guidance system
  • GE: Photon emission tomography
  • GE: Picture archiving and communication system
  • Beckman Coulter: Automatic sample management system
  • Beckman Coulter: Flow cytometer
  • Philips: Positron emission tomography–computed tomography (PET/CT)
  • Cook: Interatrial septum puncture needle
  • Edwards: Floating catheter
  • Zimmer: Knee prosthesis – tibial block

NEW APPROVAL

  1. NMPA published Approvals of Medical Devices for January 2019.

Approved for – among others – GE, Becton Dickinson, Beckman Coulter, Covidien and Zimmer were medical devices and IVDs:

  • 60 domestics
  • 15 imported Class III
  • 20 imported Class II

 

  1. NMPA granted a Priority Review status:
  • Huada Biotechnology: Hereditary deafness gene detection kit (combined probe anchored polymeric sequencing)

 

  1. NMPA granted seven Innovative Device status:
  • Sensible Medical Innovations: Lung water measuring instrument
  • Conavi Medical: Intravascular ultrasound optical coherence tomography synchronous imaging system
  • Xianjian technology: Absorbable interatrial septum defect sealing system
  • Shenzhen Beixin Life Technology: Blood flow reserve fraction (FFR) measurement system
  • Beijing Huake Chuangzhi: Digestive tract ultrasound imaging system
  • Suzhou Aggs: Optical interference tomography imaging catheter
  • Shenzhen Kaili: Intravascular ultrasound diagnostic system

For Guideline on Innovative Device Approval Procedures, please email info@ChinaMedDevice.com.

Keep yourself updated with NMPA (CFDA) News Roundup, click HERE to opt-in.

 

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.