NMPA News Roundup 201908

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NMPA News Roundup 201908

NMPA (CFDA) News Roundup covers government announcements, policies, standards, guidelines, QA/recall/AE, and new approvals in medical devices and IVDs in China.

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Highlights:

  • Market Authorization Holder (MAH) System

18 provinces began to implement contract manufacturing

  • Clinical Trial Exemptions Draft Catalog

40 Class III devices and 14 Class III IVDs are on the list

  • Beijing IVD Inspection Plan

13 requirements for IVD manufacturers to follow

Policies

  1. NMPA published the Extension of Pilot Program for Market Authorization Holder (MAH) System on August 1, introducing the MAH system for 18 provinces including the booming med-tech markets of Beijing, Zhejiang, Jiangsu and Shandong. The policy is already in effect in three provinces, Shanghai, Guangdong and Tianjin.

Companies that register devices do not have to be the manufacturers. They may commission one or multiple qualified contract manufacturing organization(s) to manufacture the approved medical devices.

The document also clarified responsibilities for MAH and Contract Manufacturer:

MAH:

  • Legally responsible for product design, clinical trial, manufacturing, sales and post-sales, recall and adverse event reporting, etc;
  • Sign Letter of Authorization and Quality Agreement with contract manufacturer(s), and clarify both responsibilities in Product Technical Requirement (PTR), quality assurance and dischargement;
  • Conduct periodical GMP audit for conduct manufacturers;
  • Ensure device traceability and conduct adverse event monitoring;
  • Ensure data authenticity in clinical trial or clinical evaluation report (CER)

Contract Manufacturer:

  • Perform obligations specified by “Medical Device Supervision and Administration Regulations”, Letter of Authorization and Quality Agreement;
  • Responsible for MAH on device quality;
  • Report quality issues to provincial NMPA where it locates.

For more info on China MAH, please click HERE.

2. NMPA published the Clinical Trial Exemptions Catalog for Medical Devices (Draft) on August 1, 2019, in an effort to implement risk-based clinical evaluation, and to make medical device clinical exemptions more consistent with internationally-accepted standard. It also calls for manufacturers’ opinion on the clinical exemption status.

The draft Catalog added exemptions for 142 medical devices, including 40 Class III; It added exemptions for 42 IVDs, including 14 Class III. If implemented, a total of 996 medical devices and 420 IVDs will be exempted from clinical trials in China since the first exemptions catalog in 2014.

For more info on clinical trial exemptions, please click HERE.

3. NMPA published the Good Manufacturing Practice Annex on Standalone Software. After satisfying Good Manufacturing Practice on Medical Devices, software manufacturers must meet the eight special requirements listed in the Standalone Software Annex:

  • Personnel
  • Equipment
  • Design development
  • Procurement
  • Manufacturing management
  • Quality management
  • Sale and after-sale
  • Adverse event monitoring and analyzing

NMPA also states that three already issued guidelines can be used as references for standalone software registration:

  • Software Technical Review Guideline
  • Cyber Security Technical Review Guideline
  • Mobile Device Technical Review Guideline

For more info on the China software GMP, please click HERE.

Guidelines

NMPA published seven draft guidelines in August:

  • Animal Study Guideline on Bioabsorbable Coronary Artery Drug Eluting Stent
  • Clinical Trial Guideline on Hernia Repair Patch (draft)
  • Technical Guideline on Mechanical Interaction Quality Control for Custom Bone Implants and Supporting Tools (draft)
  • Technical Guideline on EB Virus Nucleic Acid Detection Reagent (draft)
  • Technical Guideline on Finite Element Analysis Data of Orthopedic Metal Implants (draft)
  • Registration Guideline on Total Knee Prosthesis System (draft)
  • Registration Guideline on 3D printed Patient Matching Mandibular Prosthesis (draft)

QA/Recalls/AEs

NMPA announced Recall Notices for 22 imported medical devices in August:

Class I recalls (the most serious recall class):

  • GE: Infant radiant warmer
  • Edwards Lifesciences: Intra-aortic occlusion device
  • St.Jude Medical: Tiered-therapy cardioverter/defibrillator
  • Datascope Corp: Intra-aortic balloon pump
  • Teleflex Medical: Tracheal Tube

Class II & III recalls:

  • Siemens: Ferritin Flex reagent cartridge (FERR)
  • Siemens: Anti-CCP IgG reagent
  • BD: Automatic microbial sample processing system
  • BD: DNA extraction kit
  • Maquet Cardiopulmonary: Artificial blood vessels
  • : Medical heater
  • GE: Ultrasound diagnostic apparatus
  • Philips: Patient monitor
  • Medtronic: Disposable blur
  • Boston Scientific: Cardiac ablation system
  • Varian: HDR Brachytherapy afterloader
  • Teleflex Medical: Nurse hair clip
  • CareFusion: Bone marrow biopsy needle
  • Codman & Shurtleff: Medical tweezer
  • American Medical Systems: Urinary control system
  • Nobel Biocare: Dental implantation system
  • Howmedica Osteonics: Knee prosthesis

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 Innovative Device Status to a software on August 30.

Shanghai Yingtong: Diabetic retinopathy analysis softwareNMPA granted Priority Review Status to a medical device on August 30.

2. NMPA granted Priority Review Status to a medical device on August 30.

Beijing Xianruida: Drug-eluting peripheral balloon dilatation catheter

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

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