CFDA Monthly Roundup (January)

Overseas Inspection Results in Jan: Big Players Cited
February 10, 2019
2019 Registration Guidelines Revision Plan Announced Today: Huge Impact on Registrations and Renewals
February 25, 2019

CFDA Monthly Roundup (January)

Monthly 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. Two groups of overseas inspection results were revealed; big players were cited
  2. Guideline on Master Files to protect intellectual property and avoid repeated submission
  3. Two catalogs to help manufacturers on clinical, type testing, and registration: Catalog of Registered Clinical Trial Sites, and Catalog of NMPA Published Guidelines

Policy

  1. NMPA (CFDA) published Medical Device Master Files Filing Process (draft) for feedback on January 3, 2019. Applicants need to submit the technical confidential documents of the third-party enterprises, such as list of raw material suppliers, to NMPA to support the registration applications.

Highlights for the draft Medical Device Master Files Filing Process:

  • The medical device master files are used in the application for registration, renewal, clinical trial approval of medical devices and IVDs;
  • NMPA will establish a medical device master files registration platform and a database. The owner of the master files shall submit the main document through the registration platform.
  • Authorizing a legal agent is recommended for foreign manufacturers to communicate filling process and renew master files in time. The owners of master file shall specify the name, address, contact and authorized authority for the legal agent.
  • The documents of medical device master files must be signed and translated into Chinese.

The purpose of the medical device master file is to protect the intellectual property of the documents’ owner and to avoid the repeated submission of the same technical documents by different parties.

 

For our info on NMPA medical device master files, please click HERE.

 

  1. NMPA issued Catalog of Registered Clinical Trial Sites on January 18. 676 clinical sites are on the Catalog. Among them, 260 sites or 38.5% are located in Guangdong Province, Jiangsu Province, Shanghai City, Beijing City and Zhejiang Province.

 

  1. NMPA Center for Medical Device Evaluation (CMDE) adopted Group Decision-Making mechanism. The mechanism requires that members from each office review medical devices and IVDs collectively. It applies to supplement notification, initial registration, renewal and clinical trial approval. The reviewing time will not be affected.

For list of members in CMDE offices and their emails, please contact us at info@ChinaMedDevice.com. We also provide NMPA on-site consultation service.

Guideline

  1. NMPA issued Catalog of NMPA Published Guidelines on January 15. The Catalog covers active device, non-active device and IVD, involving clinical evaluation, registration units, network security, acceptance of overseas clinical trial data, etc.

 

  1. NMPA issued Notice of Soliciting Manufacturers’ Opinion on Companion Diagnostic Reagent Based on Same Type Antitumor Drugs. NMPA is to consult the manufacturers for the upcoming guideline.

Industry Standard

NMPA issued Standard on Capsule Endoscope (YY1298 – 2016) on January 29.

Quality Assurance

NMPA published two groups of Overseas Inspection Results on January 18 and January 30.

17 overseas medical device and IVD manufacturers were cited. BD, Boston Scientific, Varian, Deerfield Imaging are on the list. Manufacturing facilities were located in the U.S, UK, Germany, Netherlands, France, Japan, South Korea.

  • BD (U.S): Vacuum blood collection tube
  • Boston Scientific (U.S): Implantable pacemaker, automated external defibrillators (AED)
  • Rayner Intraocular Lenses (U.S.): Acrylic intraocular lens
  • Varian (U.S): Linear Accelerator (LINAC)
  • Deerfield Imaging (U.S): Magnetic resonance imaging (MRI) equipment
  • Ophtec (Netherlands): Posterior chamber intraocular lens; Capsular tension ring
  • Hermannswerder (Germany): Circulating epithelial cell (CEC) sampling needle
  • Waldemar Link (UK): Hip prosthesis
  • HumanOptics AG (Germany): Acrylic intraocular lens
  • Sophysa (France): Cerebrospinal Fluid (CSF) Drainage Systems
  • Air Liquide (France): Ventilator
  • Fujirebio (Japan): Mycoplasma pneumoniae antibody detection kit, Treponema pallidum antibody detection kit
  • Merz (U.S): Microcrystalline apatite soft tissue injection filler
  • Sysmex (Japan): HIV antigen antibody detection kit
  • Osstem Implant (Korea): Pure titanium dental implant
  • Dentium (Korea): Dental implant
  • BraunAvitum (Germany): High-throughput polysulfone membrane dialyzer

 

For more info on Overseas Inspection in January, please click Here.

For RAPS post on NMPA Overseas Inspections, please click Here.

For English version of Guideline on Overseas Inspection announced on December 28, 2018, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.

 

QA/Recall/AE

NMPA announced recall notices to 30 imported medical devices and IVDs:

  • Roche: prothrombin time detection card (Class I recall)
  • Roche: lactic acid assay kit
  • Roche: lactic acid assay kit
  • Roche: immunoglobulin M assay kit
  • Roche: total bilirubin assay kit
  • Roche: lactic acid test paper
  • Mednick: self-adhesive soft silicone silver ion foam dressing
  • Medtronic: disposable nerve stimulation probes
  • Medtronic: EEG/EMG/evoked potential measurement system
  • Medtronic: disposable surgical electrodes
  • Medtronic: disposable nerve stimulation probes
  • Cook: dilator
  • Cook: percutaneous nephrostomy catheter
  • Cook: guide wire
  • Cook: urethral dilation balloon catheter
  • Cook: ureter stent tube
  • Smith & Nephew: knee replacement
  • Smith & Nephew: intramedullary nail tool system
  • Smith & Nephew: surgical instrument for knee joint
  • Smith & Nephew: hip surgical instruments
  • Philips: electrocardiograph machines
  • Philips: patient monitor
  • Philips: electrocardiograph machines
  • Edwards Lifesciences: intra-aortic occlusion of the catheter
  • Edwards Lifesciences: floating catheter
  • Biomet Orthopedics: inverted shoulder system
  • Biomet Orthopedics: knee assembly
  • Stryker: balloon guide catheter
  • Abbott: automatic chemiluminescence immunoanalyzer
  • Beckman Coulter: quality control/focusing fluid for urine physical composition analysis

 

New Approval

  1. NMPA published Approvals of Medical Devices for December 2018. 66 domestic, 17 imported class III, 18 imported class II medical devices and IVDs have been approved. GE, Becton Dickinson, Beckman Coulter, Covidien and Zimmer are on the list.

 

  1. NMPA granted two Priority Review status:
  • Shenzhen Xudong: Radiotherapy contouring software
  • Dako North: PD-L1 detection kit

 

  1. NMPA granted seven Innovative Device status:
  • Institut Straumann AG: ceramic dental implants
  • United imaging: PET/CT
  • Shenzhen Xianjianxinkang: temporary pacemaker
  • Pulsar Vascular: bifurcation aneurysm revascularization device
  • Ourunited: image guided gamma ray stereotactic radiotherapy system
  • Shenzhen Anglo-American: endoscopic ultrasound system
  • Beijing Pinchi: MRI with implantable deep brain electrical stimulation system

 

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

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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.