NMPA (CFDA) Monthly Roundup (September)

AstraZeneca and 5 Others Caught for Violating China’s Human Genetic Regulation: Clinical Data Rejected
October 24, 2018
Rare Disease Device Guideline: Imported Device Exempt from Clinical Trial If Meeting Certain Requirements
October 29, 2018

NMPA (CFDA) Monthly Roundup (September)

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 China Med 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. We also publish market access newsletter, click HERE. For CRO services in China, click HERE.

For slides on Practical NMPA (CFDA) Compliant Clinical Trial Tips in China in 2018 that we presented on RAPS, please email info@ChinaMedDevice.com.

 

Highlights:

  1. NMPA (CFDA) new clinical exemption catalog announced to facilitate faster and lower-cost entry into China. 855 medical devices and 393 IVDs have been exempted from clinical trial since 2014.
  2. Medical Device Pre-Assessment during Supplement Phase enables you to know in advance if you meet the supplemental requirements.
  3. 12 medical device guidelines and 15 industry standards issued to expedite your registration and renewal.

 

Policy

  1. NMPA published the “Clinical Exemption Catalog for Medical Devices” on Sep 30th, in which a total of 855 medical devices and 393 IVDs exempted from clinical trial. It is the effort to implement risk-based clinical evaluation, and to make medical device clinical exemptions more consistent with internationally-accepted standard.

Since 2014 August, 4 batches of clinical exemptions have been issued by NMPA. The 4th batch was released on June 11th, 2018:

  • Class II non-active surgical devices, neuro surgical devices, cardio surgical devices, ophthalmic surgical devices, obstetrics & gynecology devices, Assisted Reproductive Technology (ART) devices and birth control devices are exempted from clinical trial now;
  • Reagents for flow cytometry, newly-classified as class II IVD, have been exempted;
  • It is the first time 31 class III IVDs being exempted, which are cancer-biomarkers.

For NMPA (CFDA) link of Medical Device Exemption Catalog, please email info@ChinaMedDevice.com.

For webinar on NMPA clinical trial & CER, please click Here.

 

  1. NMPA (CFDA) issued Notice for Medical Device Pre-Assessment during Supplement Phase September 12th. The pre-assessment can be requested by manufacturers 2 months before the submission deadline of supplemental materials; NMPA opinion will be given within 20 days after the request. The pre-assessment applies to imported Class II, Class III and domestic Class III medical devices.

 

  1. NMPA published Medical Device Regulation Index (1998-2013) on September 27. The Index includes 114 regulatory documents, covering classifications of specific devices, regulations for non-medical devices, technical guidelines, industry standards, GMPs and post-market penalties.

 

 

Guideline

NMPA (CFDA)issued 12 Technical Review Guidelines for 4 active devices, 4 non-active devices and 4 IVDs:

  • Active device: Technical Review Guideline on Medical Laser Fiber
  • Active device: Technical Review Guideline on Dual-energy X-ray Absorptiometry (DXA)
  • Active device: Technical Review Guideline on Ophthalmic High Frequency Ultrasound System
  • Active device: Technical Review Guideline on Active Device Shelf Life
  • Non-active device: Animal Test and Clinical Evaluation Guideline on Implantable Sacral Nerve Stimulation System
  • Non-active device: Quality Control and Clinical Evaluation Guideline of Spinal Implants
  • Non-active device: Technical Review Guideline on Puncture Needle Using Assisted Reproductive Technology (ART)
  • Non-active device: Technical Review Guideline on Embryo Transfer Catheter Using Assisted Reproductive Technology (ART)
  • IVD: Technical Review Guideline on Chlamydia Trachomatis and Neisseria Gonorrhoeae Reagent
  • IVD: Technical Review Guideline on Genetic Polymorphism Reagent of Drug-Metabolizing Enzyme CYP2C19
  • IVD: Technical Review Guideline on Amino Acid, Succinylacetone and Carnitine Detection Reagents
  • IVD: Technical Review Guideline on Respiratory Viral Panel Multiplex Nucleic Acid Assay

 

China Med Device, LLC has onsite test engineers to help you assess and expedite your type testing needs to shorten your renewal or new approval time. For more information, please email info@ChinaMedDevice.com.

 

Industry Standard

NMPA (CFDA) issued 15 Industry Standards on September 30th:

  • Industry Standard on Cardiopulmonary Bypass System: Damage Evaluation of Continuous Blood Flow Pump Red Blood Cell
  • Industry Standard on Dental Curing Light
  • Industry Standard on High Frequency Electrocautery Therapeutic Apparatus
  • Industry Standard on Infrared Treatment Equipment
  • Industry Standard on Carbon Dioxide Incubator
  • Industry Standard on Sterile Hypodermic Syringe
  • Industry Standard on Digital Photographic X-ray Machine
  • Industry Standard on Steam Generator
  • Industry Standard on Fatigue Test and Performance Requirements for Femoral Components
  • Industry Standard on Vertical Steam Sterilizer
  • Industry Standard on Quality Test for Medical Sterilization Steam
  • Industry Standard on Medical Device Irradiation Sterilization Process and Control Requirements
  • Industry Standard on Aperture of Rotary Dental Devices (Disc, Wheel, etc.)
  • Industry Standard on Blood Sample Collection Needle
  • Terminology for Dental Implant and Related Process

NMPA announced “2018 Medical Device Industry Standard Revision Plan” on August 7th. 99 device standards are to be issued or revised.

 

QA/Recall/AE

  1. NMPA (CFDA) announced recall notices from 15 foreign manufacturers for 23 imported medical devices and IVDs. Philips, Covidien, Siemens, Roche and Ortho Clinical Diagnostics, respectively, have multiple items being recalled.
  • Philips: a. Fetal monitor; b. Angiography X-ray machine; c. X-ray computed tomography system; d. Automated external defibrillator (AED)
  • Covidien: a. EEG machine; b. Ventilator; c. Microwave ablation electrosurgical unit
  • Siemens: a. Automatic sample processing system; b. Digital X-ray machine
  • Roche: a. DAB staining kit; b. Sample cup
  • Ortho Clinical Diagnostics: a. Vitamin B12 assay; b. Immunoassay analyzer
  • Medtronic: Neurosurgery navigation system
  • Boston Scientific: Implantable cardioverter defibrillator
  • Smith & Nephew: Knee replacement
  • Becton Dickinson: Disposable indwelling needle
  • Beckman Coulter: Uric acid kit
  • Bio-Rad Laboratories: Immunology/Protein Control
  • Fujifilm: AFP heterogeneity afp-l3 quantification kit
  • Agfa HealthCare: Digital X-ray machine
  • BioMerieux: Gram-positive bacteria drug sensitive card
  • Creganna Medical: Balloon dilatation catheter

 

  1. NMPA (CFDA) published Clinical Trial Audit Report on September 12th. Siemens and Medtronic, along with 7 domestic manufacturers, have been found incompliance in clinical audit. This is the first report NMPA issued in 2018.

For more information about the Clinical Audit Report, please click Here.

For do’s and don’ts in the clinical audit, please click Here.

 

New Approval

  1. NMPA (CFDA) published Approvals of Medical Devices for August 2018. 47 domestic class III, 20 imported class III and 13 imported class II medical devices and IVDs have been approved. Philips, Illumina and Smith & Nephew are on the list.

 

  1. NMPA (CFDA) granted Innovation Approval status to 4 medical device manufacturers.
  • Medtronic: Closed-loop insulin delivery system
  • Quanjing Hengsheng: Intravascular imaging catheter
  • Pinchi: Implantable spinal cord stimulation system
  • Mihe: Artificial cornea

For summary of innovation approval guideline, click HERE. For complete English version of the guideline, please email info@ChinaMedDevice.com.

 

  1. NMPA (CFDA) issued Priority Review notice to PD-L1 test kit, by Dako North America. Inc, on the ground of Unmet Medical Needs and No Approved Alternatives Exist.

 

Keep yourself updated with NMPA (CFDA) News Roundup, click HERE to opt-in. For market access newsletter, click HERE. For CRO services in China, click HERE.

 

 

About China Med Device, LLC

China Med Device, LLC (www.ChinaMedDevice.com), a Boston headquartered company, provides regulatory and commercialization turnkey solutions for western medical device, IVD and combination-product companies to enter China. Our NMPA (CFDA)regulatory services include: regulatory strategy, RA, clinical evaluation, clinical trial, QA, GMP and post-market compliance. Our commercialization services include: market assessment research, reimbursement, partnership, distribution qualification and management. We are a NMPA (CFDA) certified legal agent. With offices in Boston and Beijing, we can service our clients 24/7.