Monthly NMPA News Roundup (April 2019)

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Monthly NMPA News Roundup (April 2019)

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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Highlights:

  1. Sponsors can initiate clinical trials after 60 days, in the absence of rejection or deficiency notice
  2. Streamlined procedures address the combination device classification
  3. eRPS is to be implemented in two months

Policies

  1. NMPA published Notice of Modification on Medical Device Clinical Trial Approval Procedure on April 1. The Notice allows that, once the receipt of Clinical Trial Application is received, the sponsor can initiate clinical trials after waiting 60 days, in the absence of a rejection or deficiency notice. The implied approval is implemented from the date of publication. Highlights from the Notice:

1)      Before submitting a Clinical Trial Application, sponsors are encouraged to contact Center for Medical Device Evaluation (CMDE).

2)      During the 60-day period, NMPA is to review the application for safety to assure that research subjects will not be subjected to unreasonable risk.

3)      If no rejection or deficiency notice are issued, CMDE will publish the application number, address of applicant, name of medical device, model number and its configuration on CMDE website.

For our comments on Clinical Trial Approval Procedure, please click HERE.

  1. NMPA (CFDA) issued the Notice on Classification Procedures for Combination Device on April 17. The new procedures will be effective on June 1, 2019:

1)      A specialized department, NMPA Standardization Management Center (http://www.nifdc.org.cn/qxbgzx), will take over the NMPA Administration Center for combination device classification.

2)      Applicants shall submit application documents to Standardization Management Center through Combination Device Classification System.

3)      The Center will reply to the applicants with a Classification Opinion within 20 days; the Technical Opinions from an Expert Committee may be needed.

4)      If supplementary materials are needed, applicants shall submit the supplements to the Center within 30 days.

5)      The Center will announce the Classification Results periodically.

NMPA also modified the Material Requirements for combination device classification.

For our comments on Classification Procedures for Combination Devices, please click HER

3. Electronic Regulated Product Submission (eRPS) will commence by June 30, 2019, reported from NMPA Medical Device E-Filling Seminar. By the end of 2019, domestic Class III and all imported medical devices and IVDs will be required to go through this system.

Two parts, Electronic Submission and RPS Table of Contents, are included in the upcoming eRPS system, covering preparation, categorization, preview and submission of regulatory documents.

Aimed at reducing unnecessary regulatory burden for manufacturers, the eRPS will have major implications on registration, renewal, supplement and post-market surveillance. For example, NMPA officers are used to email manufacturers asking additional 00documents. With the E-filing system in place, manufacturers automatically receive the notice from NMPA. It also establishes reference on pre-market submission if the adverse events or defects occur in post-market.

For our comments on the eRPS system, please click HERE.

Guidelines

  1. NMPA issued Medical Device Animal Study Technical Review Guideline Part I: Decision Principles on April 19. The guideline lists 12 devices as examples to discuss if animal study is needed:
  • Porous coated bioprosthetic hip prosthesis
  • Electrocardiography machine
  • Cross-linked sodium hyaluronate gel for injection
  • Absorbable hernia patch
  • External defibrillation products
  • Ultrasound soft tissue cutting hemostasis system
  • Implantable pacemaker
  • Drug eluting stent
  • Degradable metal screws for internal fixation
  • Stapler
  • Anastomat
  • Absorbable surgical anti-adhesion products
  1. NMPA issued six Medical Device Guidelines:
  • Animal Study Guideline on Repairing Internal Abdominal Hernia
  • Registration Guideline on Single-Use Medicine Dispensing Syringe
  • Registration Guideline on Dental Bur
  • Registration Guideline on Single-Use Skin Stapler
  • Technical Guideline on Validation and Verification Method of Leachable
  • Technical Guideline on Protection Device for Infusion Product Sharps
  1. NMPA issued two Notices of Soliciting Manufacturers’ Opinion for the upcoming registration guideline:
  • Technical Guideline on Allowance Limits of Leachable
  • Registration Guideline on Dental Digital Imprinting Instrument

QA/Recall/AE

NMPA announced Recall Notices to eight imported medical devices:

  • Philips: Mobile X-ray Machine
  • Becton Dickinson: Disposable Sterile Needle
  • Edwards Lifesciences: Floating Catheter
  • Medtronic: Surgical Navigation Systems
  • Cook: Pleural and Pericardial Drainage Kits
  • Stryker: Bone-Powered Instrument Accessories
  • Smith & Nephew: Calcium Alginate Dressing
  • Physio-Control: Defibrillation/Monitoring System

New Approvals

  1. NMPA published Approvals of Medical Devices for March 2019. 107 domestic class III, 36 imported class III and 76 imported class II medical devices and IVDs have been approved. GE, Becton Dickinson, Beckman Coulter, Covidien and Zimmer are on the list.
  2. NMPA granted Innovative Device Status to two medical device and one software manufacturers.
  • Venus Medtech: Transcatheter artificial pulmonary valve
  • Baiou Disaier: Acellular conjunctival matrix
  • IFM Software: Hemodialysis urea clearance test software

For Catalog of Approved Innovation Devices, please click HERE.

  1. NMPA granted Priority Approval Status to one software and two IVD manufacturers:
  • Baxalta: Dosing software for recombinant human coagulation factor VIII
  • Leide Bio: M. tuberculosis specific cellular immune response test kit
  • RD Bio: Hepatitis B virus nucleic acid assay kit

 

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.