NMPA

November 6, 2019
NMPA Regulations

China Medical Device Regulations – An Overview

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 […]
March 11, 2019

ChinaMed Device is cited by BioWorld MedTech

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 […]
February 25, 2019

2019 Registration Guidelines Revision Plan Announced Today: Huge Impact on Registrations and Renewals

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 […]
January 31, 2019

Want to Meet with CFDA Reviewers Face to Face with Questions?

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 […]
January 29, 2019

Intellectual Property: CFDA Asks Feedback for Medical Device Master Files Filling Process

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 […]
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 11, 2019

CFDA Must Read: Acceptance of Overseas Clinical Data

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 […]
December 21, 2018

ChinaMed Device, with Goldman Sachs and Other Industry Leaders, Interviewed by Bloomberg on European Effects of U.S-China Trade War

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 […]
December 18, 2018

What are the CFDA interpretation of the combination products attributes?

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. […]
December 3, 2018

Era of transformation: 2018 NMPA (CFDA) Major Regulation Updates

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 […]
November 26, 2018

NMPA (CFDA) New IVD Clinical Guideline: 11 Requirements You Should be Prepared 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 […]
November 9, 2018

Our Client, RTI Surgical®, to Acquire Paradigm Spine

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 […]