Monthly CFDA News Roundup (June 2018)

Monthly CFDA News Roundup covers policies, government reports, 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.

Keep yourself updated with CFDA News Roundup, click HERE to opt-in. We also publish market access newsletter, click HERE or email info@ChinaMedDevice.com.

Highlights:

1. China’s State Council announced China Medical Device Draft Amendment. The new regulations are going through historical changes focusing on expediting innovation and achieving much needed reform.
2. 4th Batch of Clinical Exempted Medical Devices issued to facilitate faster and lower-cost entry into China.
3. Hainan, the first China province for imported device approval, published Medical Device Registration Guidance. Within 7 days you will know whether if your device gets regulatory approval.
4. CFDA issued Clinical Inspection Principles and notified 10 manufacturers, including Siemens and Medtronic, for upcoming clinical inspection.

Policy

1. State Council announced Medical Device Draft Amendment for feedback. Feedbacks need to be submitted by June 24, 2018. The decree includes 5 major changes:

• Establishment of registration holder system;
• Relaxation of clinical requirement;
• Exempted requirement of home-country-approval;
• Building career inspector system;
• More options for testing.

For RAPS post on the Amendment, please click HERE.

2. CFDA published “4th Batch of Clinical Exempted Medical Devices (Draft)” and “Revised Version: First Three Batches of Clinical Exempted Medical Devices (Draft)” for feedback. 85 medical devices and 277 IVDs have been newly-exempted from clinical trial. it is also the first time class III IVDs (31 items) have been exempted. In total, 1466 medical devices and IVDs have been granted exemption.

For complete list of the exemptions, please email info@ChinaMedDevice.com.

3. Hainan government published “Registration Guidance on Urgently Needed Imported Medical Device”. The Guidance specifies the application dossier preparation for initial registration, renewal and supplement. Within 7 days, Hainan CFDA office shall notify the applicant whether if the medical device has been approved.

For State Council’s announcement on Hainan medical device policy, click Here.

4. CFDA issued “Medical Device Clinical Inspection Principles” for feedback. It includes planning, conducting, ethical standards, reporting and sampling and clinical trial management.

For English version of above documents, please email info@ChinaMedDevice.com.

Standard

CFDA issued “Industry standard on Medical Device Quality Management System”.

Guideline

CFDA issued 3 guidelines in the month of June:

• Orthopedic and Cardiovascular: Clinical Trial Application Dossier Guideline on Implantable Medical Device
• Ophthalmology: Clinical Trial Guideline of Femtosecond Laser for Cutting Corneal Flap
• Oncology: Technical Review Guideline on Disposable Biopsy Needle

QA/recall/AE

1. CFDA issued the first notification in 2018 for clinical inspections for 9 medical devices and an IVD. Siemens, Medtronic and 8 domestic manufacturers are on the list. The inspections will be conducted at 46 clinical sites (hospitals). Read More

For information on all the clinical sites, please email info@ChinaMedDevice.com.

2. CFDA announced recall notices from 5 foreign manufacturers for 8 medical devices. 4 devices from Johnson & Johnson were called.

• Johnson & Johnson: a. Intramedullary nail; b. polypropylene non-absorbable suture; c. ortho fixation device; d. Minimally invasive retractor
• Stryker: intramedullary nail
• Biomet: knee meniscus component
• Edwards Lifesciences: cardio monitor
• Toshiba: superconduct MRI

For the reason of recall and the model number, please email info@ChinaMedDevice.com.

New Approval

1. CFDA published Directory of Registered Medical Devices for April 2018. 46 domestic class III, 23 imported class III and 21 imported class II medical devices have been approved. Siemens, Philips, Stryker, BD and Beckman Coulter are on the list.

2. CFDA issued innovation approval notice (2018 No.7) to 5 domestic medical device manufacturers. No foreign companies are on the list.

• Genomics: BRCA1/2 gene mutation detection kit
• Xiansida: oligosaccharide detection kit
• Hangtian Taixin: ventricular assist device
• Seemine SMA: memory alloy wrist fixator
• Shenzhen Jingcheng: magnesium-degradable bone repair material

CFDA granted innovation approval status to 28 medical devices in the first half of the year. Only four imported devices are on the list:

• Edwards Lifesciences: transcatheter heart valve
• BioFire Diagnostics: encephalitis/meningitis multi-pathogen nucleic acid detection kit
• Medtronic: percutaneous implanted aortic valve system
• Biosense Webster (subsidiary of J & J): 3D multichannel radiofrequency balloon catheter

For regulations about CFDA Innovation Approval and Priority Review, please contact us at info@ChinaMedDevice.com.

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

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 certified as legal agent. 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.