CMDE has announced the following schedule for Pre-Submission Communication: Date CMDE Department March 1, 2024 Dept 1/2 of Technical Review Dept 1 of Clinical and Biostatistics March 8, 2024 Dept 3/4 /5 of Technical Review March 15, 2024 Dept 6 of Technical Review Dept 2 of Clinical and Biostatistics General Operation Dept March 22, …
The following is the summary of medical device technical review in January 2024: Submissions Overview In Process of Technical Review:1311 Technical Review Completed:1331 Submissions Accepted Document Review:1576 Submissions Accepted:2113 Filing Modification :933 Import Class I Device Filing:187 RFEs and Responses to RFEs RFE released: 643 RFE Response Accepted: 540 Advisory Meetings Meeting initiated: 5 Meeting …
Summary of medical device technical review in January 2024 Read More »
As of January 31, 2024，the medical device registration and licensing information in China provinces is as follows: No. Provinces Domestic medical device products Medical Device Manufacturing Medical device Distribution On-Line Sales Filing Third-Party Platform for Medical Device Sales Registration Registration License（pcs） Filing（pcs） Permit（pcs） Filing（pcs） Permit （pcs） Filing（pcs） 1 Beijing 8124 4087 770 671 2883 43808 …
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Recently, China CMDE.NMPA published registration technical review report of composite plate system. Product name: Composite Plate System Product category: Class III Applicant name: CarboFix Orthopedics Ltd. Product structure and composition: This product consists of bone plates and bone screws. The bone plate is made of carbon fiber polyetheretherketone composite material. The material grade is PEEKPEEK-OPTIMA …
China CMDE.NMPA registration technical review report – Composite Plate System Read More »
On February 7, 2024, China NMPA released 20 Medical Device Industry Standards including YY 1001-2024 “All Glass Syringe”. The following is the detail information: No. Standard No. Title Status Scope of application Effective Date 1 YY 1001—2024 All glass syringes Revised This document specifies the structural type, materials, requirements, marking, packaging, transportation and storage of …
On February 7, 2024, China CMDE.NMPA issued the draft guidance “Guideline for registration review of estrogen receptor and progesterone receptor antibody reagents and detection kits (2023 revised version)”. CMDE called for the public comments on the draft guideline before February 29, 2024.
On February 6, 2024, China CMDE.NMPA issued the draft Guidance “Guideline for Registration and Review — Clinical Evaluation of IVD Reagents for Colorectal Cancer Screening” (Draft). CMDE called for the public comments on the draft guideline before March 4, 2024.
On February 8, 2024, China CMDE.NMPA issued the draft guidance “Guidelines for Substantial Equivalence Review — Clinical Evaluation of RF/Microwave Ablation Equipment”. CMDE called for the public comments on the draft guideline before March 8, 2024.
On February 5, 2024, CMDE released the Technical Review Guidance for Laser Equipment for Myopia and Amblyopia (2024 No. 6). Login for original document.
On February 5, 2024, China CMDE released 4 guidance documents for ME Equipment submission and review as the following: Login for more information.
