March

March 28, 2018

Weekly CFDA News Roundup (Mar 18th to Mar 24th)

Weekly CFDA News Roundup covers policies, regulations, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by China Med Device, LLC, a consulting firm specializing […]
March 27, 2018

CFDA: 22 Foreign Devices Recalled Last Week

CFDA quality requirements have escalated. From Mar 18 to Mar 24, CFDA announced Medical Device Recall Notices from 17 foreign manufacturers for 22 medical devices. Boston Scientific, Siemens, Becton Dickinson, […]
March 23, 2018

New Leaders of CFDA, with More Expertise, Emerged

The cabinet Reshuffle Plan, unveiled by China’s State Council on 13 Mar, established the National Market Supervision Administration (NMSA). CFDA, along with Administration for Industry & Commerce (AIC), and Administration […]
March 21, 2018

Weekly CFDA News Roundup (Mar 11th to Mar 17th)

Weekly CFDA News Roundup covers policies, regulations, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by China Med Device, LLC, a consulting firm specializing […]
March 20, 2018

CFDA Held Forum for 3D Printed Device

Industry forum for additive manufactured (3D-printed) medical device was held by CFDA on 12 March. 70 experts, physicians, manufacturers and CFDA reviewers attended the forum to discuss the details of […]
March 19, 2018

Concentrated Care in China Facilitates Clinical Trial Recruitment and Data Gathering

Source: New York Times China does not have a distributed primary and community-based network of healthcare.  The picture here may make you think Chinese are waiting in line for football […]
March 15, 2018
Grace Fu Palma, CEO of China Med Device, Speaks to a group of MedTech company executives

Grace Palma, CEO of China Med Device, is interviewed by RAPS on CFDA restructuring

On March 13, China State Council released a draft plan to reshuffle government ministries, specifying the duty of China Food and Drug Administration (CFDA). At that night, Grace Palma, CEO of […]
March 15, 2018

China Pediatric Devices and Diagnostics Expected To More Funding and Growth

In the National People’s Congress (NPC) and the Chinese People’s Political Consultative Conference (CPPCC) that are being held, representatives and committee members have all suggested that R & D for […]
March 13, 2018

CFDA’s Name is Disappearing as China Announces Cabinet Reshuffle Plan

China State Council on Tuesday released a massive cabinet reshuffle plan to make the government better-structured, more efficient, and service-oriented. CFDA, along with Administration for Industry & Commerce, and Administration […]
March 12, 2018

Weekly CFDA News Roundup (Mar 4th to Mar 11th)

Weekly CFDA News Roundup covers policies, regulations, QA/recall/AE, and new approvals in medical device and IVD in China.  It is edited by China Med Device, LLC, a consulting firm specializing […]
March 9, 2018

Chunli Orthopedic got 2 innovation approvals from CFDA

China accelerates medical device innovation. In February 2018, 7 products got approved through fast track pathway. Among them are two from Chunli Orthopedic, based in Beijing. No foreign manufacturers are […]
March 6, 2018

Monthly CFDA News Roundup (Feb 2018)

Monthly CFDA News Roundup covers policies, regulations, QA/recall/AE, and new approvals in medical device and IVD in China.  It is edited by China Med Device, LLC, a consulting firm specializing […]