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Category: Index

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

92 Standards Become Non-Binding

The NMPA issued the “Announcement on the transformation of 92 mandatory industry standards and research projects for medical devices into recommended industry standards and research projects” on September 9, 2022.

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nmpa guidelines for nanomaterials

Eighteen Industry Standards Issued in One Day

The NMPA published eighteen industry standards on August 22, 2022, to guide manufacturers for local type testing and regulatory approval: YY/T 0325-2022 Disposable sterile urinary catheter YY/T 0334-2022 General requirements

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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

Eighteen Standards Issued in One Day

The NMPA published eighteen industry recommended standards on July 6, 2022 to guide manufacturers for local type testing and regulatory approval: YY/T 0273-2022 Dentistry-Dental amalgam blender YY/T 0290.4-2022 Ophthalmic optics

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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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