On March 26th, 2024, China CMDE.NMPA released “Guidelines for Registration Review of High-Frequency Surgical Equipment “(2023 Revised Edition). Contact us for the original document.
CMDE is starting the preparation of the ” Guidelines for Registration Review of Metal Bone Marrow Aspiration Needle”, ” Guidelines for Registration Review of Memory Alloy Rib Plating System”, ” Guidelines for Registration Review of Mesh for Skull Repairing”, ” Guidelines for Registration Review of Sternal Strapping/Grasping Fixation System”, “Guidelines for the Registration Review of …
Sterile medical devices, which have direct or indirect contact with the human blood system or human tissue, play a critical role in the patients’ safety. More stringent requirements regarding the production process control and quality control are required by China GMP. The following are some examples of validation and verification items, which may help you …
China CMDE is starting the preparation of the “Guidelines for Registration and Review of Dengue Virus NS1 Antigen Detection Reagents” and “Guidelines for Registration Review of Helicobacter Pylori Resistance Gene Detection Reagents”. Companies participating in the preparation work are now being solicited, and domestic and foreign production companies, scientific research institutions, clinical institutions, etc. with …
On March 18, 2024, China CMDE.NMPA released four medical device registration review guidelines: 1.“Guidelines for registration review of Corneal topography”, 2.“Guidelines for registration review of Laparoscopic surgery system – Part 2: Animal study necessity analysis and protocol design requirements”, 3.” Guidelines for Registration Review of Laparoscopic Surgical Systems Part 3: Three-Dimensional Endoscopy”, 4.” Guidelines for …
Four Guidelines for Registration Review were released by CMDE.NMPA Read More »
On March 19, 2024, CMDE.NMPA released “Guidelines for Registration Review of Medical Device Usability Engineering”. Log in for original document.
On March 18, 2024, CMDE.NMPA issued the “Guideline for Registration Review of Monkeypox Virus Nucleic Acid Detection Reagents” Log in for original documents.
On March 18, 2024, China CMDE.NMPA added a number of recommended pathways for clinical evaluation of medical devices. Email: info@gvmmedical.com for original documents.
Recently, China CMDE.NMPA published registration technical review report of Implantable wireless pacemaker. Product name: Implantable wireless pacemaker Product category: Class III Applicant name: Abbott Medical Product structure and composition: This product consists of a pulse generator with built-in battery and electrodes and a loading tool. This product is used in conjunction with programmable controllers, delivery …
China CMDE.NMPA registration technical review report – Implantable wireless pacemaker Read More »
