The Monthly NMPA (CFDA) News Roundup covers government announcements, policies, standards, guidelines, QA/recall/AE, and new approvals in medical devices and IVDs in China.
Highlights:
- Real World Data in Hainan
Enables overseas manufacturers to find alternative clinical pathway
- Unique Device Identification Rules
Pay attention to the timeline, device type and your code-issuing agency
28 draft registration guidelines were issued in one day
Policies
1. Leaders discussed the Real World Data (RWD) Pilot Program - a cost-effective and less time-consuming alternative to the traditional clinical trial - at a meeting in Boao, Hainan Province. NMPA hosted the meeting on October 10-11, joined by National and Hainan Provincial NMPA officials and eight overseas manufacturers.
Real World Data will become another clinical pathway for device approval in China. Overseas manufacturers can obtain approval for the RWD pilot program through Hainan provincial NMPA to start using devices in clinical settings prior to national NMPA approval. This is especially significant for manufacturers with high price tags, as RWD program participants can generate clinical data in the actual clinical environment with service fees whereas the traditional clinical trial needs to be complimentary. Certain protocols and guidelines need to be followed for the Real World Data to be admitted as part of the clinical evidence for submission.
Hainan is the first province to pilot Real World Data in China. It offers an additional clinical option to the currently available clinical pathways such as clinical evaluation report and overseas clinical data acceptance. As RWD can be used prior to national NMPA approval, it can significantly shorten the time to begin selling devices in China.
2. NMPA's final version of Unique Device Identification (UDI) Rules went into effect on October 1, 2019. The Rules are to adequately identify medical devices through their manufacturing, distribution and use. When fully implemented, the label of all devices in China will include a unique device identifier in human- and machine-readable form.
NMPA has formulated relevant standards and specifications for UDI and established a UDI database. UDI code-issuing agencies are required to submit an Annual UDI Report for the previous year to NMPA, by January 31. The UDI code-issuing agencies have to be certified by NMPA.
The registrants shall upload, maintain and renew the product identification and related data on the UDI database after the product is approved or renewed, and before the commercialization of the product. And the registrants are held accountable for the authenticity, preciseness and completeness of UDI data.
The UDI Rules also implicates the requirements of submission materials. For the first trial group of 64 implantable devices, if the registration has been accepted or approved before August 1, 2020, the registrant shall submit the product identification of the smallest sales unit in the registration management system during the product's renewal or modification.
Guidelines
- NMPA issued 28 draft guidelines on October 18 for feedback. The guidelines cover one class III device, 27 class II devices and IVDs (cardiovascular, gastroenterological, urological, dental, gynecological and pediatric products), and manufacturing methods.
Class III device:
- Registration Guideline on Balloon Catheter (draft)
Class II devices:
- Registration Guideline on Disposable Medical Rinse Product (draft)
- Registration Guideline on Non-absorbable Surgical Sutures (draft)
- Registration Guideline on Furrow Sealant (draft)
- Registration Guideline on Heat and Humidity Exchanger (draft)
- Registration Guideline on Pediatric Devices (draft)
- Registration Guideline on Low Frequency Galvanometer (draft)
- Registration Guideline on Ureteral Stent (draft)
- Registration Guideline on Electric Pneumatic Hemostatic Apparatus (draft)
- Registration Guideline on Pulmonary Function Test Apparatus (draft)
- Registration Guideline on Disposable Sterile Vaginal Dilator (draft)
- Registration Guideline on Medical Carbon Dioxide Incubator (draft)
- Registration Guideline on Uterine Salpingography Balloon Catheter (draft)
- Registration Guideline on Transnasal Nutrition Tube Products (draft)
- Registration Guideline on Dental Film Type Orthotics (draft)
- Registration Guideline on Shockwave Therapeutic Instrument (draft)
- Registration Guideline on Hot Compression Bag (draft)
- Registration Guideline on Audiometer (draft)
- Registration Guideline on Dental Phosphate Etchant Products (draft)
Class II IVDs:
- Registration and Labeling Guideline on Domestic-Use IVDs (draft)
- Registration Guideline on Prolactin Detection Reagent (draft)
- Registration Guideline on Determination of Serum Amyloid A Reagent (draft)
- Registration Guideline on Rheumatoid Factor Assay Reagent (draft)
- Registration Guideline on Total Triiodinic Thyroproline Assay Reagent (draft)
- Registration Guideline on Determination of 25-Hydroxyvitamin D Reagent (draft)
- Registration Guideline on Specific Protein Immunoanalyzer (draft)
Manufacturing methods:
- Registration Guideline on Reprocessing Instructions and Validation Methods for Reusable Medical Devices (ii) (draft)
- Registration Guideline on Shelf Life Validity of Sterile Medical Device Container and Seal System (draft)
- NMPA published five final guidelines in October:
- Registration Guideline on 3D Printed Implantable Bone, Joint and Oral Hard Tissue
- Registration Guidelines on Aspartic Aminotransferase Assays
- Registration Guidelines on Total Cholesterol Reagent
- Registration Guidelines on Uric Acid Reagent
- Registration Guideline on Urea Determination Reagent
QA/Recalls/AEs
NMPA announced Recall Notices for 16 imported medical devices in October:
- Philips: Forte gamma camera
- Philips: Respirator
- Medtronic: Navigational surgical tool
- Medtronic: Surgical power system
- Cook: Embryo transfer catheter
- Smith & Nephew: Hinged knee system
- Edwards Lifesciences: Patient monitor
- Becton Dickinson: Prefilled catheter washer
- Bard: Central venous catheter (Implantable infusion port type)
- Beckman Coulter: Automatic dyeing cell counter
- Maquet: Pressure steam sterilizer.
- Terumo: Artificial heart-lung machine
- Howmedica Osteonics: Hip joint grid
- Aesculap: Occipital cervical thoracic fusion system
- BioMerieux: Human immunodeficiency virus P24 antigen detection kit
- Haemonetics: Disposable blood cell separator
New Approvals
NMPA granted Innovation Status to two domestic manufacturers on October 28.
- Beijing Yukun: Coronary angiography image analysis software for vascular stenosis
- Shanghai Bodong: Coronary CT image flow reserve fraction calculation software
If you want an English copy of Implementation Plan of Real World Data in Hainan, or UDI Rules, or have any idea about the regulatory establishments in China, please leave a comment here or email me at gpalma@ChinaMedDevice.com.
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------