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 …
CMDE is starting the preparation of the “Guideline for Registration and Review of Human T Lymphocytic Leukemia Virus Antibody Detection Reagents” and “Guideline for Registration and Review of Human Leukocyte Antigen (HLA) Gene DNA Typing Detection Reagents”. Companies participating in the preparation work are now being solicited, and domestic and foreign production companies, scientific research …
CMDE is starting the preparation of the “Guideline for Registration Review of Human KRAS Mutation Gene Detection Reagents (PCR Method)”, “Guideline for Registration Review of Glucose-6-Phosphate Dehydrogenase Detection Reagents” and “Guideline for Registration Review of Enzyme Detection Reagents Traceability” . Companies participating in the preparation work are now being solicited, and domestic and foreign production …
To strengthen the supervision and regulation of the Medical Device Industry, NMPA Hubei Branch conducted 43 Unannounced Inspection in 2023. Thirty-seven (37) Domestic Manufacturing Facilities and six (6) OEM Manufacturer Facilities outside of Hubei were involved. Two of them were for-cause inspections related to Adverse Events. There were 268 Inspection Citations recorded, 32 of …
43 Unannounced Inspection was conducted by NMPA Hubei Branch in 2023 Read More »
CMDE publish a total of 106 product technical reviews reports in 2023. The following is the list of the reports:
Medical device registration fees in China Medical Device Class Initial Amendment Renewal(every five years) Clinical trial application fee(High-risk medical devices) Domestic class III RMB 153600 RMB 50400 RMB 40800 RMB 43200 Imported class II RMB 210900 RMB 42000 RMB 40800 — Imported class III RMB 308800 RMB 50400 RMB 40800 RMB 43200 For more information, …
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 …
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 …
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 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 …
