As some of you may already notice, NMPA (CFDA) has gone through structural changes these years. Last month some new regulations are released. Please see below NMPA Newsletter, covering government announcement, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in China.
Highlights
- 2019 National Quality Inspection Plan
The inspections, affecting 54 medical devices, will be based on Industry Standards and Product Technical Requirements (PTRs).
The tariff can be exempted or refunded if imported devices meet certain criteria.
- Certificate Authority (CA) certificate
CA certificate, for the upcoming eRPS system, must be applied for and held by manufacturers' legal agent in China.
Policies
- 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:
hip components, bone plate, etc.;
digital radiograph X-ray equipment, mobile X-ray machine, etc.;
hemodialyzer, single use blood perfusion devices, hemodialysis concentrates, etc.;
custom fixed denture, ultrasonic scaler, etc.;
soft contact lens, contact lens care solution, viscoelastic, etc.;
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.
- 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:
- Difficulties in finding alternative sources of goods;
- Adding tariffs will cause serious economic damage to the applicants;
- 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.
- 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.
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
- 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.
- NMPA granted Innovative Device Approvals to two manufacturers on May 6.
- Beijing Med-Zenith: Left Atrial Appendage (LAA) Occluder
- Shanghai Push Medical: Left Atrial Appendage (LAA) Occluder
- NMPA granted Innovative Device Status to two manufacturers on May 27.
- Suzhou MedRobot: surgery endoscope system
- Nanjing Guiji: diabetes-related retinopathy analysis software
- NMPA granted Priority Review Status to two manufacturers on May 27.
- Medtronic: Transmission sheath
- Ustar: Mycobacterium tuberculosis complex group nucleic acid detection kit
For those of you that are going through the processes above, such as quality inspection or electronic submission, I'd love to hear your thoughts!
If you have any questions or want to know more, feel free to reach out to me via private message or email.
Thanks!
------------------------------
Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------