Register for Upcoming Webinar on DEC. 8 @ 11AM
2026 China NMPA Bluebook is here:
NMPA (CFDA) issued Guideline for Acceptance of Overseas Clinical Trial Data of Medical Devices on January 11th, 2018. A year later, we revisit this important
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
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
In order to guide the applicant to make proper application, NMPA(CFDA) has published the summary of the attribute definition results of drug-device combination products starting
From January 1st, 2019, China requires foreign company names to be provided in Chinese. The Chinese company name must meet following requirements: Use simplified Chinese.
NMPA (CFDA) published Guideline for Imported Medical Device Legal Agent (Draft) for feedback on Aug 3rd, 2018. The draft guideline lists 3 responsibilities for legal
The compliance with the NMPA (CFDA) clinical trial requirements in China is getting more strictly audited and reinforced. On November 13th, NMPA (CFDA) issued the
NMPA (CFDA) published draft IVD Clinical Trial Guideline for feedback on November 22nd, 2018 during the U.S. Thanksgiving holiday. After initial clinical guideline issued in
With the development of the medical technology, the NMPA(CFDA) started to strengthen the management of the combination products. In 2018, CFDA held a symposium on
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
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
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