On February 8, 2024, China CMDE.NMPA issued the draft guidance “Guidelines for Substantial Equivalence Review — Clinical Evaluation of RF/Microwave Ablation Equipment”.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, China CMDE released 4 guidance documents for ME Equipment submission and review as the following: Login for more information.
In the year 2023, China CMDE issued 67 guidance documents to help technical review and application submission preparation. The following is a list of the guidance documents: No. Guidance 1 Guidance for Registration Review of Novel Coronavirus (2019-nCoV) Antigen Detection Reagent (2023 No. 2) (2023-03-02) 2 Guidance for Registration Review of Novel Coronavirus (2019-nCoV) Antibody …
Total 67 Guidance Documents Were Issued by CMDE in the year 2023 Read More »
On January 23, 2024, CMDE publicly sought opinions on the “Guideline for the Technical Review of the Registration of Phacoemulsification and Vitrectomy Devices and Accessories in Ophthalmology (Revised 2023).” This guideline aims to assist registration applicants in standardizing the preparation and writing of registration application materials for ophthalmic phacoemulsification and vitrectomy devices and accessories. It …
China CMDE Releases Draft of Guideline for Comments Read More »
Date Issued: January 18, 2024 This guideline outlines the essential criteria for monkeypox virus nucleic acid detection reagents. Applicants must assess the applicability based on the specific characteristics of their product. If the guideline is not applicable, it is imperative to provide rationale and the corresponding scientific basis. Additionally, applicants should enhance and refine the …
Document Number：No. 3, 2024 Date Issued: January 15, 2024 To further guide the standardized development of real-world research on medical devices, CMDE has formulated this guideline. It serves as a guiding document for registration applicants and technical reviewers. This guideline applies to real-world research on medical devices but is not applicable to real-world research on IVD( in vitro diagnostics）. …
The guidance document was released on July 26, 2023. It’s the NMPA current thinking about the clinical evaluation of the Powered Laser Surgical Instrument. This guideline applies to powered laser surgical instruments intended to reduce human hair and wrinkles, treat hyperpigmented skin diseases and skin vascular diseases, and treat scars (Product Code 09-03-01, Class III). …
Guidelines – Clinical Evaluation of the Powered Laser Surgical Instrument Read More »
In order to further standardize the management of medical X-ray diagnostic equipment (Class III), the Center for Device Evaluation of the State Food and Drug Administration organized the formulation and release of the “Guidelines for Clinical Evaluation and Registration Review of the Same Type of Medical X-ray Diagnostic Equipment (Class III)”. Scope of application This …
There are three scenarios for the key inspection contents when medical device manufacturers carry out supervision and inspection: For medical device registrants and filers who produce by themselves: 1. The implementation of laws and regulations, medical device production quality management regulations by medical device registrants and record holders; 2. Organize production in accordance with mandatory …
Medical Device Production Management – Supervision and Inspection Requirements Read More »
In order to further standardize the management of medical devices such as blood melting equipment, the Center for Device Evaluation of the State Food and Drug Administration organized and issued 14 guidelines for the registration and review of medical device products including the “Guidelines for the Registration and Review of Blood Melting Devices”: 1. Guidelines …
14 Medical Device Product Registration Review Guidelines Released Read More »
