Regulatory Open Forum

For English version of Innovation Approval Procedure and link of any guidelines listed, please email info@ChinaMedDevice.com.

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 China Med Device, LLC (www.ChinaMedDevice.com), a consulting firm specializing in China CFDA regulatory, CRO and market access services.  

 

Highlights:

1. Innovation Approval Guideline, aiming on a standardized procedure and facilitated market acceptance, took effect on 1^st October;
2. Guidance on rare diseases medical device exempts clinical trial for certain imported humanitarian devices;
3. CFDA published 38 guidelines, covering benefit-risk assessment, cardiovascular, urology and orthopedic devices and immune oncology IVDs, etc.

 

Policy

1. Draft guideline "Special Review and Approval Procedure for Innovative Medical Devices", issued on May 7^th, 2018, came into force on October 1^st.

 

The guideline paves a fast track for regulatory clearance on eligible foreign medical devices. The granted priority manifests in the classification determination, pre-clinical testing, QMS auditing, and CFDA reviewing/approving processes. Meanwhile, a specially-assigned CFDA officer would check in and provide guidance throughout the whole expedite process.

Qualifications:

• Class II / Class III Medical Device with significant clinical application value,
• Own valid invention patents,
• Have China PTO coverage,
• Complete the preliminary study on prototype with traceable data, and
• An authorized in-country legal entity.

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

2. CFDA issued Registration Guideline on Medical Device for Rare Disease on October 18th, 2018 in the effort to address the huge unmet medical needs. The guideline lists 3 situations when clinical trial can be exempted:

• Preclinical research, such as literature review, animal test, modeling and simulation, proves that benefits overweigh risks;
• Comparison with equivalent marketed device, which proves safety and efficacy;
• Imported devices, with home country approval, meet the requirements for Accepting Overseas Clinical Data.

The guideline also states the Conditional Approvals will be used to accelerate the R&D of rare disease devices and IVDs. Devices and IVDs can be approved without enough clinical data, if manufacturers are committed to do further clinical research.

For our comments about the guideline, please click HERE.

 

Guideline

CFDA issued 38 Technical Review Guidelines, covering benefit-risk assessment, cardiovascular, urology and orthopedic devices and immune oncology IVDs, etc.

 

• Guideline on Medical Device Benefit-Risk Assessment
• Technical Review Guideline on Disposable Heart Fixation Device
• Technical Review Guideline on Colloidal Gold Immunochromatography Analyzer
• Technical Review Guideline on Follicle Stimulating Hormone Detection Reagent
• Technical Review Guideline on Limb Compression Therapy Equipment
• Technical Review Guideline on Direct Ophthalmoscope
• Technical Review Guideline on Stone Retrieval Basket
• Technical Review Guideline on Nasal Bile Drainage Tube
• Technical Review Guideline on X-Ray Tube Assembly
• Technical Review Guideline on Biofeedback Therapy Device
• Technical Review Guideline on Disposable Cervical Dilatation Balloon Catheter
• Technical Review Guideline on Dental Drill
• Technical Review Guideline on Sterilization for Sterile Medical Device
• Technical Review Guideline on Antibody Detection Reagent
• Technical Review Guideline on Simple Respirator
• Technical Review Guideline on Total Bile Acid Assay Kit
• Technical Review Guideline on Passive and Assistive Range of Motion (ROM) Exercise Device
• Technical Review Guideline on Disposable Endoscopic Biopsy Forceps
• Technical Review Guideline on Dental Impression Material
• Technical Review Guideline on Plasma Freezer
• Technical Review Guideline on Suture Needle
• Technical Review Guideline on Glycosylated Albumin Assay
• Technical Review Guideline on Enteral feeding pump
• Technical Review Guideline on Root Tip Locator
• Technical Review Guideline on Anti-Thyroid Peroxidase Antibody Assay Kit
• Technical Review Guideline on Creatinine Assay Reagent
• Technical Review Guideline on Urinary Dynamics Analyzer
• Guidance on Review of Medical Devices for Rare Diseases
• Technical Review Guideline on Orthopedic External Fixation System
• Technical Review Guideline on Laryngeal Mask
• Technical Review Guideline on Bone Cement Cannula Assembly
• Technical Review Guideline on Anesthesia Machine
• Clinical Evaluation Guideline on Centrifugal Blood Component Separation Equipment
• General Considerations for Animal Studies for Medical Devices
• Technical Review Guideline on Implantable Drug Delivery Equipment
• Technical Review Guideline on Polymethyl Methacrylate Bone Cement for Joint Replacement
• Technical Review Guideline on Vertebroplasty Balloon Dilatation Catheter
• Technical Review Guideline on Radiofrequency Ablation Device

For our comments about the unprecedented number of guidelines, click HERE.

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.

 

QA/Recall/AE

1. CFDA changed recall class, from class II to class I, for 15 IVD reagents, including DAB substrate kit, Hematoxylin and Eosin stain kit, immunohistochemistry reagent and dyes for microscopy, etc. Class I is the most urgent class of recall CFDA issues.

 

Roche Diagnostics GmbH and Ventana Medical Systems are affected.

 

2. CFDA announced recall notices to 12 imported medical devices and IVDs.0

 

• Medtronic Sofamor Danek: Spinal fixation system
• GE: Archiving transmission system
• Philips: Semi-automatic external defibrillator
• Boston Scientific: Cardiac resynchronization therapy pacemaker (CRT-P)
• Beckman Coulter: Lipase assay kit
• Smith & Nephew: Knee surgery instrument
• Cordis Corporation: Balloon dilatation catheter
• LeMaitre Vascular: Radiopaque marker
• Merit Medical: High pressure tubing
• Biomet Orthopedics: Single-use cement spacer mold
• Bard Peripheral Vascular: Mammary positioning needle
• Braun Surgical: Absorbable surgical suture

For model number and reason of recalls above, please email info@ChinaMedDevice.com.

 

New Approval

1. CFDA published Approvals of Medical Devices for September 2018. 70 domestic class III, 20 imported class III and 48 imported class II medical devices and IVDs have been approved. GE, Becton Dickinson, Beckman Coulter, Covidien and Zimmer are on the list.

 

2. CMDE granted Innovation Approval status to 4 medical device manufacturers.

• Zhongke Chaojing: intensity modulated radiation therapy machine
• Kede: human tumor marker DR-70 test kit
• Tianhong Shengjie: venous stent
• Zap: X-ray stereotactic radiation system

For complete English version of Innovation Device guideline, please email info@ChinaMedDevice.com.

3. CMDE issued Priority Review notice to respiratory viral panel multiplex nucleic acid assay, by Cepheid Inc, on the ground of Unmet Medical Needs and No Approved Alternatives Exist.

Keep yourself updated with 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.

 

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Grace Fu Palma
China Med Device, LLC
MA, U.S.
gpalma@chinameddevice.com
978-390-4453
www.chinameddevice.com
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