On September 2, 2021, Guideline for Registration Review of Neurosurgical and Cardiovascular Surgical Devices – Knife, Scissors and Needles (Draft) drafted by CMDE of NMPA was released to solicit comments, which aims to help and guide the registration applicants to prepare the application dossiers to meet the standards of technical review. Any feedback needs to be submitted by October 18, 2021. more…
To further optimize the business environment in Hainan Boao Lecheng pilot zone of international medical tourism (the Pilot Zone), simplify the approval process of imported drugs and medical devices in urgent clinical need, optimize the approval mode, improve the effectiveness of regulatory services, facilitate the public to timely use imported drugs and medical devices in urgent clinical need, the Several Measures to Further Optimization of Regulatory Services to Support the High-Quality Development of Hainan Boao Lecheng Pilot Zone of International Medical Tourism (the Measures) was issued by Hainan Provincial Drug Administration and related bodies. more…
On September 15, 2021, NMPA issued the results of sampling inspection on medical devices. A total of 12 varieties, including semiconductor laser therapy machine, nasal endoscope and surgical clothes, were subject to product quality supervision and sampling inspection, of which 23 batches (sets) of products failed to meet the standards. more…
Recently, CMDE of NMPA issued two new guidelines, including Guidelines for Registration Review of Preparation of Product Technical Requirements for Medical Devices (revised in 2021) and Guidelines for Registration Review of Data Submission Requirements for Clinical Trials of Medical Devices. Any feedback needs to be submitted by October 8, 2021 and October 10, 2021, respectively. more…
On September 7, 2021, the NMPA released the Guideline on Technical Review on Predicate-Comparison Based Clinical Evaluation of Intravascular Catheters. The Guideline is used to guide the registration applicant to carry out the clinical evaluation for predicate comparison of intravascular catheter products and help the evaluation agency to conduct a standardized review on the clinical evaluation of such products. more…
Your feedback counts! On September 6, 2021, NMPA’s CMDE published the Draft Guideline for Registration Review on Quality Uniformity of Additive Manufacturing Metal Implants for public comments. Any feedback needs to be submitted by October 8, 2021. more…
On August 23, 2021, NMPA issued the Nomenclature Guidelines for Neurological and Cardiovascular Surgical Devices and the Nomenclature Guidelines for Medical Diagnostic and Monitoring Devices, so as to further standardize the generic names of medical devices and strengthen the life cycle management of medical devices. more…
