NMPA (CFDA) Newsletter (May 2019)

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NMPA (CFDA) Newsletter (May 2019)

The NMPA (CFDA) Newsletter 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.

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

Highlights

  1. The inspections, affecting 54 medical devices, will be based on Industry Standards and Product Technical Requirements (PTRs).
  2. The tariff can be exempted or refunded if imported devices meet certain criteria.
  3. CA certificate, for the upcoming eRPS system, must be applied for and held by manufacturers’ legal agent in China.

Policies

  1. NMPA (CFDA) announced “2019 National Quality Inspection Plan”. The Plan asks provincial NMPA offices and type testing centers to conduct inspections based on Industry Standards and Product Technical Requirements (PTRs). The plan covers 54 medical devices and IVDs:
  • Orthopedic

hip components, bone plate, etc.;

  • Imaging

digital radiograph X-ray equipment, mobile X-ray machine, etc.;

  • Hematology

hemodialyzer, single use blood perfusion devices, hemodialysis concentrates, etc.;

  • Dental

custom fixed denture, ultrasonic scaler, etc.;

  • Ophthalmic

soft contact lens, contact lens care solution, viscoelastic, etc.;

IVD

Thalassemia gene detection Kit, Ketamine detection kit, Hepatitis B virus surface antigen detection kit, Treponema pallidum antibody detection kit, Cystatin C assay reagent, Human chorionic gonadotropin test strip, etc..

The Plan also lists institutions and procedures for inspecting, retesting and appealing.

For more info on the “2019 National Quality Inspection Plan”, please click HERE.

2. The Customs Tariff Commission (CTC) of the China State Council published the “Notice on Trial Implementation of Tariff Waiver Plan on Goods from USA and Canada” on May 13. The tariff can be exempted or refunded if the imported products meet the following three criteria:

a. Difficulties in finding alternative sources of goods;

b. Adding tariffs will cause serious economic damage to the applicants;

c. Adding tariffs will have major negative structural impacts on related industries, or bring serious social consequences (including on industry development, technological progress, employment, environmental protection, etc.)

The China State Council issued two tariff plans worth $66 billion on goods imported from U.S. last year. For the first batch of tariffed items, the waiver can be applied from June 3 to July 5, 2019. For the second batch of tariffed items, the waiver can be applied from September 2 to October 18, 2019.

For more info on the “Tariff Waiver Plan”, please click HERE.

3. NMPA issued “Notice on the Application of Certificate Authority (CA) certificate for Medical Device Registration Service Platform (eRPS)” on May 7. CA certificate is a digital certificate for NMPA’s new electrical submission platform, which should be applied for and held by manufacturers’ legal agent in China.

The electronic Regulated Product Submission (eRPS) system will be launched on June 24, 2019.

For more info on the Certificate Authority, please click HERE.

Guidelines

NMPA issued six Medical Device Guidelines:

  • Technical Guideline on Medical Device Electronic Submission
  • Clinical Evaluation Guideline for Centrifugal Blood Component Separation Equipment
  • Registration Guideline on Active Medical Device Service Life
  • Registration Guideline on Resin Teeth
  • Registration Guideline on Contraceptive Intrauterine Device (IUD)
  • Registration Guideline on Totally Implantable Access Port (TIAP)

QA/Recalls/AEs

NMPA announced Recall Notices to 20 imported medical devices and IVDs:

Class I recall

  • Johnson & Johnson: Endo-surgery staple
  • Edwards Lifesciences: Intra-Aortic Occlusion Device

Class II and III recall

  • GE: Single Photon Emission Tomography and X-ray Computed Tomography (SPECT/CT) System
  • Philips: Color Diagnostic Ultrasound Machine
  • Siemens: Creatine Kinase Assay Kit
  • Roche: Fully Automatic Bio Analysis Machine
  • Roche: D-dimer Detection Card
  • Medtronic: Mulching Stent
  • Medtronic: Surgical Burs
  • Boston Scientific: Helium-Neon Laser System
  • Edwards Lifesciences: Venous Sheath
  • Biomet: Knee Surgery Tool
  • Cook: Percutaneous Sheath Introducer (PSI)
  • Cook: Single Use Central Venous Catheter
  • Leica: Cryostat Microtome
  • CareFusion: Clear Needleless Connector
  • Ethicon: Temporary Cardiac Pacing Lead
  • Ethicon: Polyester Non-Absorbable Suture
  • Zimmer: Dental Implants
  • Maquet: Surgical Lighting

New Approvals

  1. NMPA published Approvals of Medical Devices for April 2019. 52 domestic class III, 26 imported class III and 18 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 Approvals to two manufacturers on May 6.
  • Suzhou MedRobot: surgery endoscope system
  • Nanjing Guiji: diabetes-related retinopathy analysis software

3. NMPA granted Innovative Device Status to two manufacturers on May 27.

  • Medtronic: Transmission sheath
  • Ustar: Mycobacterium tuberculosis complex group nucleic acid detection 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.

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.