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Category: Guideline

nmpa guidelines for nanomaterials

NMPA: 27 Guidelines Issued in One Day

The NMPA published the 27 registration review guidelines on September 15, 2022, which involve a wide range of indications, from chemistry, hematology to dental and urology, etc. It is to

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nmpa guidelines for nanomaterials

Ten IVD Guidelines Issued in One Day

The NMPA published ten draft guidelines for IVDs on June 23, 2022, for feedback. They are proposed to direct manufacturers for local type testing and regulatory approval. IVD Guidelines NMPA

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nmpa guidelines for nanomaterials

NMPA Roundup April 2022

Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros issued in April 2022. These updates are presented by China Med Device, LLC, your partner

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nmpa guidelines for nanomaterials

NMPA Elaborating on Testing Report

According to the “Administrative Measures for Registration and Filing of Medical Devices” and “Administrative Measures for Registration and Filing of In Vitro Diagnostic Reagents”, the medical device testing report can

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nmpa guidelines for nanomaterials

34 NMPA Guidelines issued in December 2021

The NMPA published 34 guidelines in December 2021, involving provisions on clinical trials, same-variety comparison, and regulatory review for a wide range of indications. Significantly referred to many FDA guidance,

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