Register for Upcoming Webinar on DEC. 8 @ 11AM
2023 China NMPA Bluebook is here:
China National Medical Products Administration regulates medical devices and pharmaceutical products across China. The NMPA was also known as China Food and Drug Administration in the past. For medical device
On March 1st, 2019, Grace Palma, CEO of China Med Device, is interviewed by BioWorld MedTech about the revised registration guidelines for medical devices. With revised registration guidelines, China moves closer
NMPA announced the “2019 Medical Device Registration Guidelines Revision Plan” today (February 25), in which 86 medical devices, IVDs and documentation methods are included. The Guidelines Revisions are aimed to
Do you need assistance in NMPA (CFDA) consultation before initiating your registration? In the areas where it is not clearly defined, it is better to double check your registration questions
On January 3, 2019, NMPA (CFDA) issued Medical Device Master Files Filing Process (draft) for feedback. Feedbacks need to be submitted by Feb 4, 2019. Medical device master file in
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
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 guideline to remind foreign medical
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 guideline to remind foreign medical
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.
Do you know the NEW Registration Holder System for Medical Devices in China? Do you know the NEW post-market surveillance requirements in China? Do you know the latest clinical requirements
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
Email: info@chinameddevice.com
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