China medical device

How long does it take for the first registration period of Class II and Class III medical devices?

First registration period for Class II medical devices Project approval stage Plan, budget, 1 month. Document preparation before acceptance Considering that the average cost of testing is 6 months, it may vary depending on the product situation. Clinical trials cannot be performed in parallel with testing, and the clinical time should be calculated separately, and …

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medical device review

Guidelines for Clinical Evaluation and Registration Review of the Same Type of Medical X-ray Diagnostic Equipment (Class III)

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 …

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Medical deivce consulting company

Summary of medical device technical review work in July 2023

The CMDE implements the decisions and deployments of the Party Central Committee, the State Council and the bureau’s party group, and conducts technical review, pre-review of supplementary materials, medical device technical consultation, approval of some administrative approval items, registration certificate number and data circulation, etc. in accordance with functions and procedures. various tasks. Status of …

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Medical Devices Compliance Q&A

Question: How to choose the extraction solvent in the study of the extraction performance of contact lens products? Answer: It is recommended to choose the solvents recommended in Table 2 in GB/T11417.7 “Test Methods for Physical and Chemical Properties of Contact Lenses”. It is recommended to choose different types of solvents, which are mild extraction …

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Medical Device Production Management – Supervision and Inspection Requirements

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 …

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“Opinions on Further Strengthening the Supervision of Entrusted Production of Medical Device Registrants (Draft for Comment)”

In order to fully implement the main responsibility for the quality and safety of medical device registrants, prevent and control the hidden risks of medical device entrusted production, and strengthen the supervision of medical device entrusted production, the State Food and Drug Administration organized the drafting of “Opinions on Further Strengthening the Supervision of Medical …

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Interpretation of “Guiding Principles for Registration Review of Medical Device Animal Test Research”

The State Food and Drug Administration issued the “Guidelines for the Registration and Review of Animal Experimental Research on Medical Devices Part I: Decision-Making Principles (2021 Revision)” and “The Second Part of the Guidelines for the Registration Review of Medical Device Animal Experimental Research: Experimental Design and Implementation Quality Assurance” (Notice No. 75 of 2021) …

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