-
NMPA Issues Announcement on Performing Consistency Evaluation of the Quality and Efficacy of Generic Chemical Injections
2020-05-14
NMPA released an Announcement on May 14, 2020, with decisions made to perform consistency evaluation of the quality and efficacy of generic chemical injections (hereinafter referred to as the consistency evaluation of injections), relevant issues are announced as follows.
-
NMPA Issues Guidance for On-Site Inspection of Independent Software Appended in Good Manufacturing Practice for Medical Devices
2020-06-04
NMPA organized to formulate and released on June 4, 2020 the Guidance for On-Site Inspection of Independent Software Appended in Good Manufacturing Practice for Medical Devices.
-
NMPA Issues 5 Technical Review Guidances for the Registration of Tendon and Ligament Fixation Systems and Others
2020-06-05
NMPA organized to formulate and released on June 5, 2020 the Technical Review Guidance for the Registration of Tendon and Ligament Fixation Systems, Technical Review Guidance for the Registration of 3D Printed Acetabular Cups, Technical Review Guidance for the Registration of 3D Printed Artificial Vertebral Body, Technical Review Guidance for the Registration of Facial Implant Prostheses for Plastic Surgery, and Technical Review Guidance for the Registration of Total Knee Prosthesis Systems.
-
NMPA Issues Three Guidances including the Guidance for Nomenclature for Generic Names of Medical Imaging Devices
2020-06-30
NMPA has organized to formulate the Guidance for Nomenclature for Generic Names of Medical Imaging Devices, Guidance for Nomenclature for Generic Names of Active Implanted Devices and Guidance for Nomenclature for Generic Names of Dental Instruments, which are issued on June 22, 2020.
-
NMPA Revises Package Insert of Docusate Sodium and Dantron Capsules
2020-05-22
On May 22, 2020, NMPA issued an Announcement with decisions made to revise the [adverse reactions], [precautions], etc. in the package insert of Docusate Sodium and Dantron Capsules.
-
NMPA Issues Guidance for the Preservation of Essential Documents for Drug Clinical Trials
2020-06-08
NMPA organized the formulation of the Guidance for the Preservation of Essential Documents for Drug Clinical Trials, which has been released on June 8, 2020 and shall come into effect as from July 1, 2020.
