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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.
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
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
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
The NMPA finalized the “2022 Medical Device Industry Standards Revisions Plan” on April 28, 2022, just two weeks after the draft version. The plan includes 23 mandatory and 93 recommended
The NMPA issued the “2022 Medical Device Industry Standards Revisions Plan” today, April 14, 2022, for public opinions. Comments need to be submitted by April 21. The plan includes 23
The NMPA released the Medical Devices Standards Annual Report on February 18, 2022. In the year of 2021, 35 national standards and 146 industry standards for medical devices were published.
The NMPA issued the “Optimizing Mandatory Standards for Medical Devices (Draft)” on January 5, 2022 for feedback. Feedbacks need to be submitted by February 10. The document lists 458 standards,
The NMPA released 19 industry standards on December 10, 2021, with indications ranging from cardiovascular, plastic surgery, oncology, clinical chemistry and immunology, etc. The standards revisions are to provide manufacturers
NMPA issued the final version of “2021 Medical Device Industry Standards Revisions Plan” on July 8, in which 77 medical devices and IVDs are affected. The Standards Revisions are aimed
NMPA issued the 2021 Medical Device Industry Standards Revisions Plan (draft) on May 26, in which 77 medical devices and IVDs are affected. The Standards Revisions are aimed to facilitate
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