July

July 31, 2018

Overseas Inspection: There are Defects CFDA Chasing

Following the 13th Five Year Plan (2016-2020), CFDA has conducted overseas inspection covering all imported high-risk medical devices. Since November 2017 when CFDA began to publish overseas inspection results, 24 […]
July 25, 2018

Weekly CFDA News Roundup (July 16th to July 22nd)

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) […]
July 24, 2018

Imported Medical Devices Account for 93 % of Total Recalls in Shanghai

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 […]
July 18, 2018

AI Industry Pushing Forward, Mandated by China State Council

China State Council published an article on AI medical device on July 9th, aiming to propel China to the leadership of AI devices, especially AI-infused imaging diagnostics for eyes, lungs […]
July 17, 2018
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Webinar on CFDA Oversea Inspection– It’s time to take it seriously!

Are you ready for CFDA’s oversea inspection? Do you comply with Chinese Medical Device Good Manufacturing Practice? Does your current quality system meet the Chinese legal requirements? Join us for […]
July 17, 2018

CFDA Q&A: Clinical Trial Quality Management for Medical Devices

Q: How to calculate the one-year validity period for the type testing report issued by the inspection institution? A: For the multi-center clinical trials, the one-year validity period is calculated […]
July 16, 2018

Two Invoice Policy Will Reshape China Distribution Landscape (2)

Two Invoice Policy in China Brings Great Opportunities for The Integration of Medical Device Industry At the end of January 2018, the “Two Invoice Policy” has been implemented in 24 […]
July 12, 2018

Two Invoice Policy Will Reshape China Distribution Landscape (1)

“Two Invoice Policy” means that the pharmaceutical production enterprise issues one invoice to the circulation enterprise, and the circulation enterprise issues one invoice to the hospital. It effectively prevent the […]
July 11, 2018

CFDA: Two Ophthalmology Clinical Guidelines Issued

CFDA published Clinical Guideline on Rigid Gas Permeable (RGP) Contact Lens and Clinical Guideline on Soft Contact Lens on July 5th, to facilitate the applicants with clinical trial process on […]
July 9, 2018

CFDA’s Opinions on Device Registration (June 2018)

Monthly Opinions on Device Registration covers preclinical, clinical and registration issues in medical device and IVD in China. It is published by CFDA and edited by China Med Device, LLC […]
July 3, 2018

CFDA:Imported Medical Devices Only Account For 15% of Innovation Approvals

CFDA granted innovation approval status for 28 medical devices in the first half of the year, covering the indication of cardiovascular (10), oncology (7), orthopedic (5), immunology (4) and urology […]
July 3, 2018

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) […]