CRO Updates

January 23, 2020
medical device clinical trial phrases

Medical Device Clinical Trial Phases in China: A Practical Step-by-Step Guide

Going through China’s medical device clinical trial phases can be painstaking in terms of the cost and time. While more and more clinical exemptions have been issued by China’s NMPA […]
December 31, 2019

More Class III, Class II Medical Devices and IVDs Exempted from Clinical Trial

NMPA published the final version of “Clinical Trial Exemptions Catalog for Medical Devices” on December 20, 2019. It is an effort to implement risk-based clinical evaluation, and to make medical […]
December 14, 2018

9 Clinical Trials Have Compliance Issues in NMPA Inspection

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 […]
October 14, 2018

Siemens, Medtronic Found Incompliance in CFDA Clinical Audit

For the first time in 2018, NMPA (formerly CFDA) issued clinical trial incompliant companies report.  In this Medical Device Clinical Audit Notice on September 12th, Siemens and Medtronic, along with […]
September 7, 2018

Key Points to Navigate the Class III Medical Device Type Testing – Part 2 Biological Testing

Biological testing points 1. Preparation of testing materials Technical requirements, specifications are equivalent to performance testing. The contracts may be different, it needs to be cleared in advance. 2. Identify […]
September 4, 2018

Key Points to Navigate the Class III Medical Device Type Testing – Part 1 Performance Testing

China’s guideline requires that the Class III medical device registration must submit a test report, and the test report should be issued by a certified medical device testing center. The […]
August 17, 2018

Problems and Suggestions for Medical Device Clinical Auditing in China

In conjunction with the problems audited by the CNDA for clinical trials of medical devices, China Med Device, LLC summarizes some common problems and put forward some suggestions.   Clinical […]
July 17, 2018

CFDA Q&A: Clinical Trial Quality Management for Medical Devices

Q: How to calculate the one-year validity period for the type testing report issued by the inspection institution? A: For the multi-center clinical trials, the one-year validity period is calculated […]
July 11, 2018

CFDA: Two Ophthalmology Clinical Guidelines Issued

CFDA published Clinical Guideline on Rigid Gas Permeable (RGP) Contact Lens and Clinical Guideline on Soft Contact Lens on July 5th, to facilitate the applicants with clinical trial process on […]
July 2, 2018

Faster and Lower-Cost Entry into China: 4th Batch of Clinical Exempted List Published

On June 11, CFDA published “4th Batch of Clinical Exempted Medical Devices and IVDs (Draft)” for feedback. 85 medical devices and 277 IVDs have been newly-exempted from clinical trial in […]
July 2, 2018

Siemens and Medtronic to be Inspected on Clinical Site

The GCP requirements on medical devices have intensified. On June 25, CFDA issued the first notification in 2018 for the upcoming clinical inspections for 9 medical devices and an IVD. […]
May 30, 2018

Join Our Webinar: Key Ingredients for Effective China SDA(CFDA) CER and Clinical Trial

Which is your clinical pathway in China, CER or Clinical Trials? How to get oversea clinical data accepted by China SDA? How can you use CFDA unapproved device in China […]