Blog

August 10, 2018

Monthly CFDA News Roundup (July)

Monthly 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), […]
August 7, 2018

China Counters U.S. Tariff – Time for More Manufacturing Setup in China

The China State Council issued tariff plan worth $60 billion on the 2nd batch of goods imported from U.S. on August 3. It will impose duties of 25%, 20%, 10% […]
August 1, 2018

CFDA New Medical Device Classification Catalogue Effective August 1st, 2018

CFDA Medical Device Classification Catalog draft was published August 31, 2017.  A year later, it became effective on August 1, 2018. New registration application after August 1, should follow the […]
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 […]