guideline

January 17, 2019

CFDA Monthly Roundup (December)

Monthly CFDA News Roundup covers government announcement, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by ChinaMed Device, LLC (www.ChinaMedDevice.com), a […]
January 4, 2019

NMPA (CFDA) Must Read—— New Guideline for Oversea Inspection

On December 28th, 2018, National Medical Products Administration (NMPA) issued ‘Administrative Regulations of Drug and Medical Device Overseas Inspection’ (NMPA order No. 101 2018) implemented from the date of publication. […]
November 6, 2018

CFDA Monthly Roundup (October)

Monthly CFDA News Roundup covers government announcement, 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), […]
November 1, 2018

CFDA: 27 Medical Device Guidelines Released in One Day

CFDA issued 27 device guidelines on Oct.8th, covering benefit-risk assessment, cardiovascular, urology and orthopedic devices and immune oncology IVDs, etc. Whether you are renewing or doing new registration, your medical […]
October 29, 2018

Rare Disease Device Guideline: Imported Device Exempt from Clinical Trial If Meeting Certain Requirements

CFDA issued Registration Guideline on Medical Device for Rare Disease on October 18th, 2018 in an effort to address the huge unmet medical needs. The guideline lists three situations when […]