Register for Upcoming Webinar on DEC. 8 @ 11AM
2024 China NMPA Bluebook is here:
On Dec 18, ChinaMed Device, LLC is interviewed by Bloomberg on European effects of U.S-China Trade War. Other interviewees include Goldman Sachs, BS Global Wealth Management, and European Union Chamber
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 2009 to the present.
In order to strengthen the management of medical devices clinical trials, the National Medical Products Administration(NMPA, formally CFDA) launched the Notice of First Batch Medical Device Clinical Trial Inspection Results
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. Chinese company name should be
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 agents for the first time:
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 2nd notification in 2018 for
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 September 2014, NMPA (CFDA) has
Congratulate our client and long-term partner, RTI Surgical, on acquiring Paradigm Spine! RTI Surgical, a global surgical implant company, has signed an agreement to acquire Paradigm Spine, a leader 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 “Preliminary attribute definition and evaluation
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),
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
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
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