Weekly CFDA News Roundup covers government reports, 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.
Government Report
Shanghai CFDA office released Medical Device Half Year Recall Report on July 20. Total 165 medical devices have been voluntarily recalled in Shanghai for the first half of 2018, including 154 imported devices (93%) and 11 domestic devices (7%). Foreign manufacturers include Roche, Siemens, GE, Philips, Abbott, Becton Dickinson, Boston Scientific, Smith &Nephew, etc.
The number of voluntary recalls in the first half of 2018 was increased by 66.7% year-on-year.
For reasons of the recalls and suggestions given by Shanghai CFDA office, click HERE.
Policy
CFDA published an article on biodegradable materials and called for research and development of those materials. CFDA approved biodegradables include hernia mesh, dura mater, nerve repair material, anal fistula, absorbable fixation nail, tissue clip, facial injection filling material, degradable sinus stent, sodium hyaluronate ophthalmic viscoelastic, artificial cornea Matrix, dermal matrix, etc.
For 28 standards and guidelines CFDA specifies in the article, please email info@ChinaMedDevice.com.
Guideline
CFDA issued a draft guideline for feedback. Feedbacks need to be summited by August 17.
- Dental: Technical Review Guideline on Synthetic Resin Teeth
QA/Recall/AE
CFDA issued National Inspection Notice #65 and identified 7 devices: intraocular lens, slit-lamp microscope, carbon dioxide (CO2) laser, light therapy machine, suction tube, electronic thermometer, nerve and muscle stimulator.
Devices from 5 foreign manufacturers, out of 40 in total, have been found defects:
- HexaVision SARL: intraocular lens
- Rayner Intraocular Lenses: intraocular lens
- Lenstec: intraocular lens
- Bausch & Lomb: intraocular lens
- Natus Medical: light therapy machine
New Approval
CFDA granted innovation approval status to 1 foreign manufacturer and 2 domestic ones.
- 富士レビオは(Fushi Ruibiou): Hepatitis B surface antigen (HBsAg) detection kit
- MicroPort: intraoperative stent
- Zhuoruan Medtech Xiansida Hangtian Taixin: biodegradable hernia mesh
CFDA issued an innovation approval to quantitative pulmonary blood flow measuring system, by Pulse Imaging, a company based in Shanghai. It obtains Quantitative Flow Ratio (QFR) based on quantitation with coronary angiography.
For summary of innovation approval guideline, click HERE. For complete English version of the guideline, please email info@ChinaMedDevice.com.
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About China Med Device, LLC
China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, QA and post market compliance. We are experienced in handling innovation approvals and priority reviews. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have offices in Beijing, Suzhou and Boston. Our management team has 100+ years of combined experience in medical device and IVD and has been involved with 1,000+ CFDA certificates and 200+ companies’ success.