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Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in August 2023. These updates are presented by China Med Device, LLC, your partner
The NMPA released the “Medical Device Benefit-risk Assessment Guideline (2023 revised version)” on July 18, 2023. Through the benefit-risk judgment table in which standard review consideration factors are listed, the
The NMPA released the “Medical Device Benefit-risk Assessment Guideline (2023 revised version)” on July 18, 2023. Through the benefit-risk judgment table in which standard review consideration factors are listed, the
The NMPA published eight new guidelines in August 2023, to direct manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions. Full List For an English copy of any
The NMPA published eight new guidelines in August 2023, to direct manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions. Full List For an English copy of any
The NMPA summarized 76 Medical Electrical Standards, GB 9706 Series, which is equivalent to IEC60601. The standards have been effective since May 1, 2023. For active product manufacturers with existing
The NMPA summarized 76 Medical Electrical Standards, GB 9706 Series, which is equivalent to IEC60601. The standards have been effective since May 1, 2023. For active product manufacturers with existing
The NMPA reclassified certain neurosurgical, cardiac surgery, orthopedic, and hemodialysis, radiological equipment and devices and modified intended use for some with an announcement on August 21, 2023. Read the list
The NMPA reclassified certain neurosurgical, cardiac surgery, orthopedic, and hemodialysis, radiological equipment and devices and modified intended use for some with an announcement on August 21, 2023. Read the list
The NMPA renewed the list of raw material master files on August 14, 2023. Four foreign manufacturers became master file owners for their raw materials or key components in August:
The NMPA renewed the list of raw material master files on August 14, 2023. Four foreign manufacturers became master file owners for their raw materials or key components in August:
Here is our summary of our successful study with China GMP’s support. Guide a US manufacturer with 5 global sites to comply with China GMP Objectives Key Activities Recommended Areas