Regulatory Open Forum

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 CFDA regulatory, CRO and market access services.  

 

Keep yourself updated with CFDA News Roundup, click HERE to opt-in. We also publish market access newsletter, click HERE. For CRO services in China, click HERE.

 

Highlights:

1. NMPA (CFDA) Overseas Inspection Guideline is published to standardize inspection procedure and enhance GMP requirements
2. Innovation Device Approval Procedures takes into effect; Six innovative device status are granted
3. 94 Industry Standards are planned for revision for the year of 2019

Policy

1. The NMPA (CFDA) is putting greater emphasis on the quality system management and post-market compliance of overseas medical device manufacturers. To standardize overseas inspection procedure, on December 28, 2018, NMPA issued Guideline of Overseas Inspection for Drugs and Medical Devices. This guideline applies to overseas manufacturers who are marketing or intended to market their medical devices in China.

          Here are the highlights of this regulation:

• Overseas inspection doesn't only contain manufacturing site, but also includes overseas R&D location.
• Manufacturers need to, within 20 business days of the notice, submit the Medical Device Overseas Inspection Basic Information Table to the center; and, within 40 business days of the notice, submit site master file and other required information as required by the Content of Site Master File.
• The inspection team may take the copy, the photograph, the camera, and so on collect evidence data.
• The inspection team shall complete the inspection report within a specified time frame.
• The inspection center shall provide feedback, in writing, per the Medical Device Overseas Inspection Deficiency guidelines to manufacturers within 40 business days after the inspection.
• Manufacturers shall, within 40 business days of receiving inspection feedback, shall submit the corrective outcome to the center. If the manufacturer could not provide the corrective outcome within the time frame, the manufacturer shall submit a detailed corrective progress, plan, and updates over time.
• The inspection center shall send a comprehensive evaluation report to the manufacturer within 40 business days of the receipt of corrective outcomes.

          For more information on Guideline of Overseas Inspection for Drugs and Medical Devices, please click Here.

2. NMPA Innovative Device Approval Procedures (NMPA order No. 83 2018) became effective on December 1^st. The granted priority manifests in the classification determination, pre-clinical testing, QMS auditing, and NMPA reviewing/approving processes. Also, a specially-assigned NMPA officer would check in and provide guidance throughout the whole expedite process.

          Qualifications for Innovation Device Status (meet spontaneously):

• 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.

3. NMPA issued 2019 Medical Device Industry Standard Revision Plan (draft) on December 11^th. The draft Plan covers 94 industry standards for medical devices and IVDs.

 

For English versions of the Innovative Device Approval Procedures or Industry Standard Revision Plan, please email info@ChinaMedDevice.com.

Guideline

NMPA (CFDA) issued 7 Technical Review Guidelines in December:

• Technical Review Guideline on Registration Dossier for Innovation Approval
• Technical Review Guideline on Laser Fiber
• Technical Review Guideline on Bilirubin Plasma Adsorber
• Technical Review Guideline on Biopsy Needle
• Technical Review Guideline on Gauze Dressing
• Technical Review Guideline on Surgical Staple
• Technical Review Guideline on Disposable Suction Tube

Industry Standard

NMPA (CFDA) issued 27 Industry Standards in December:

• Industry Standard on High Frequency Jet Ventilator
• Industry Standard on Ophthalmic Optics - Intraocular Lenses - Part 3: Mechanical Properties and Test Methods
• Industry Standard on Special Requirements for Safety of Heat Radiation Treatment Equipment
• Industry Standard on Radiofrequency Ablation Catheter
• Industry Standard on Disposable Medical Gloves - Part 4: Test Methods for Resistance to Puncture
• Industry Standard on Test Methods for Packaging of Sterile Medical Devices - Part 1: Guide to Accelerated Aging Test
• Industry Standard on Cleaning and Sterilizing Machines - Part 2: Cleaning and Sterilizing Devices for Hygrothermal Disinfection of Surgical and Anesthesia Instruments, Etc.: Requirements and Tests
• Industry Standard on Cleaning and Sterilizing Machines - Part 3: Cleaning and Sterilizing Device for Hygrothermal Disinfection of Human Waste Containers: Requirements and Tests
• Industry Standard on Ultrasonic Hydrophones Part 2: Calibration of Hydrophones for Ultrasonic Fields Below 40 MHz
• Industry Standard on Liquid Infusion Filters For Infusion - Part 2: Test Method for Withdrawal of Candida Albicans with 1.2 µm Nominal Pore
• Industry Standard on Dentistry - Dental Treatment Machines - Part 2: Gas, Water, Suction and Waste Water Systems
• Industry Standard on Portable Dental Unit
• Industry Standard on Ultrasound Therapy Equipment
• Industry Standard on Specific Requirements for Silicone Gel Filled Breast Implants - Performance Requirements for Silicone Gel Fillings - Part 2: Limits for Extractable Substances
• Industry Standard on Human Immunodeficiency Virus Antibody Detection Kit (Immunochromatography)
• Industry Standard on Technical Conditions for Mobile X-Ray Computed Tomography Equipment
• Industry Standard on Basic Requirements for Unique Identification of Medical Devices
• Industry Standard on Blood Donor and Blood Component Compatibility Determination - Part 1: Blood Component Residue Assessment
• Industry Standard on Water Resistance of Medical Protective Clothing Materials: Impact Penetration Test Method
• Industry Standard on Multi-channel Physiological Recorder
• Industry Standard on Joint Replacement Implant - Shoulder Prosthesis - Test Method for Dynamic Evaluation of Joint Stagnation or Separation
• Industry Standard on Tissue Engineering Medical Device Products - In Vivo Magnetic Resonance Evaluation Method for Regenerated Knee Articular Cartilage
• Industry Standard on Dentistry Magnetic Attachment
• Industry Standard on Method for Determination of Residual Diphenylmethane Diisocyanate (MDI) in A Single-Use Polyurethane Infusion Device
• Industry Standard on Surgical implants - Test methods for Solubility of Calcium Phosphate Granules, Articles and Coatings
• Industry Standard on Medical Biochemical Incubator
• Industry Standard on Functionality and Compatibility Test Method for Remote Medical Imaging Equipment

For any guidelines or industry standard listed above, please email info@ChinaMedDevice.com.

QA/Recall/AE

NMPA announced recall notices to 31 imported medical devices and IVDs:

• GE: X-ray computed tomography
• GE: Multi-functional incubator
• GE: Bone cement implants
• GE: Image archiving system
• GE: Ventilator
• GE: Ankle fracture surgery kit
• Beckman Coulter: Automatic bioanalysis machine
• Beckman Coulter: Automatic sample processing system
• Beckman Coulter: Urine analysis test strip
• Beckman Coulter: Interleukin 6 calibrator
• Abbott: Active thrombin test card
• Abbott: Hepatitis A virus IgG antibody test kit
• Roche: Prothrombin Time (PT) test card
• Philips: Patient monitor
• Philips: X-ray computed tomography
• Medtronic: Brain surgery navigation system
• Medtronic: Ventral patch
• Boston Scientific: Saline perfusion microelectrode ablation catheter
• Baxter Healthcare: Disposable intravenous infusion bag
• William Cook Europe: Microwire
• Biomet Trauma: Wrist mini-locking plate
• Ortho-Clinical Diagnostics: Automatic bioanalysis machine
• Livanova Deutschland: Cardiopulmonary exchange water tank
• Carestream Health: Digital radiography
• Ortho-Clinical Diagnostics: Low density lipoprotein assay kit
• Radiometer Medical: Immunoassay analyzer
• Radiometer Medical: Disposable arterial blood sample collector
• Fuji: Diagnostic ultrasound system
• Bellco: Hemodiafiltration filter
• Bio-Rad Laboratories: Glycated hemoglobin A1c test kit
• American Orthodontics: Stainless steel orthodontic wire

For device models and recall reasons, please email info@ChinaMedDevice.com.

Nw Approval

1. NMPA (CFDA) published Approvals of Medical Devices for November 2018. 74 domestic class III, 14 imported class III, and 45 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 status to 6 medical devices and IVDs:

• Syntellix: Biodegradable magnesium alloy compression screw
• Meril Life Sciences: Sirolimus-eluting bioabsorbable vascular stent
• Jianshi Biotech: Transcatheter manual tricuspid valve
• Shenming: Temperature sensitive embolization agent
• Xianjian Biotech: Peripheral stent
• Xingtai Pule: Degradable polymer rapamycin eluting stent

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 ChinaMed Device, LLC 

ChinaMed Device, LLC (www.ChinaMedDevice.com), a Boston headquartered company, provides regulatory and commercialization turnkey solutions for western medical device, IVD, CDx and combination products to enter 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. We are a NMPA (CFDA) certified legal agent with offices in Boston and Beijing enabling us to service our clients 24/7.

 

------------------------------
Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com
978-390-4453
www.ChinaMedDevice.com
------------------------------