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2023 China NMPA Bluebook is here:
China’s Ministry of Science and Technology published the “Details for the Implementation of the Human Genetic Resources Regulations” on June 1, 2023. Based on “Human Genetic Resources Management Regulations” effective
The NMPA issued the “Clinical Pathway Recommendations for Certain Categories of Medical Devices” on May 19, 2022. The document suggests manufacturers how to choose clinical evaluation exemption, predicate device comparison
On March 2, 2022, Human Genetic Resources Administration of China (HGRAC) released the “Frequently Asked Questions on Human Genetic Resources Management”. On March 22, 2022, the Ministry of Science and
We want to share the highlights of China regulatory submission case from NMPA reviewers’ perspectives on an iliac vein stent system. Both technical and clinical requirements are outlined below. In
The NMPA and China Health Commission released the “Quality Management Practice Specification for Clinical Trials of Medical Devices”, implemented from May 1, 2022. The “China GCP” covers the whole process
The Greater Bay Area (GBA) – with a total population of approximately 71.2 million people (5% of China’s total population) – includes nine mega-cities of Guangdong province: Guangzhou, Shenzhen, Zhuhai,
If devices are not on the clinical evaluation exempt catalog but have an NMPA-approved predicate device to show substantial equivalence, per the “Guidance for Clinical Evaluation of Medical Devices” published
The NMPA published 34 guidelines in December 2021, involving provisions on clinical trials, same-variety comparison, and regulatory review for a wide range of indications. Significantly referred to many FDA guidance,
NMPA published the “Evaluation of the Safety and Effectiveness of Medical Devices Containing Nanomaterials Part I: Framework” on August 30, 2021, directing manufacturers on key issues of nanomaterials’ registration. The
The NMPA held a conference in Beijing on December 27, 2021 to discuss the Real World Data program and better enhance the approval system for imported devices. Allergan’s Glaucoma treatment
The new “Regulation for Medical Device Administration and Supervision”, Order 739, effective since June 1, 2021, allows the implied permission for class III devices conducting clinical trial. It states that,
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros for November 2021. These updates are presented by China Med Device, LLC, your partner in
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