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2026 China NMPA Bluebook is here:
The NMPA issued the “Guideline of Drug-coated Balloon Dilatation Catheter (draft)” today on June 22, 2022, collecting public opinions. Feedbacks need to be submitted by July 22, 2022. Referring to
NMPA issued the “Clinical Pathway Recommendations for Certain Categories of Medical Devices” on June 16, 2022. The document suggests manufacturers how to choose clinical evaluation exemption, predicate device comparison or
The NMPA released 55 revised or newly established medical device standards on May 18, 2022, with indications ranging from cardiovascular, plastic surgery, oncology, clinical chemistry and immunology, etc. The Standards
The NMPA Medical Device Standardization Administration released the “Medical Device Classification Results for 2020-2021”. The document identifies 155 Class III, 505 Class II and 143 Class I medical devices, and
The NMPA granted Innovation Approvals to Medtronic and three others in May 2022: Medtronic: Transcatheter Implantable Leadless Pacing System Beijing Hengsheng: Disposable Intravascular Imaging Catheter Beijing Hengsheng: Intravascular Imaging Equipment
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
The NMPA reclassified 27 medical devices and modified intended use for some with an announcement on March 30, 2022. The classification and definition of the following devices are affected: NMPA
With the rapid development of the industry and continuous emergence of new technologies, new materials and new products, the “Medical Device Classification Catalog”, effective from August 2018, is in the
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 published 33 review reports from January to April 2022. Three categories are included: innovation, priority review and Class III predicate-comparison devices. Overseas manufacturers including Boston Scientific, Edwards Lifesciences
Hainan Boao special zone allows overseas unapproved medical devices, IVDs, drugs in China to be used. In addition to the overseas medical products being sold and commercialized faster through this
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros issued in April 2022. These updates are presented by China Med Device, LLC, your partner