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NMPA Releases 48 New Guidelines for Medical Device Registration Review

28 05 2024

On May 27, 2024, the Center for Medical Device Evaluation (CMDE) of the National Medical Products Administration (NMPA) released 48 new guidelines for the registration review of various medical devices, including electric photography beds. The guidelines cover a wide range of medical device categories, such as diagnostic equipment, therapeutic devices, auxiliary equipment, rehabilitation tools, and in vitro diagnostic reagents. These guidelines aim to standardize the registration process, enhance industry standards, and ensure the safety and effectiveness of medical devices. Detailed guidelines for specific devices, including medical gas alarm systems, air-oxygen blenders, radiotherapy laser positioning devices, and various testing reagents, are provided to support manufacturers in meeting regulatory standards. The full texts of these guidelines are available on the NMPA's official CMDE website.

On May 27, 2024, to further standardize the management of medical devices such as electric photography beds, the Center for Medical Device Evaluation (CMDE) of the National Medical Products Administration (NMPA) has organized the formulation and revision of 48 guidelines for the registration review of various medical devices, including the "Guidelines for the Registration Review of Electric Photography Beds," now officially released.

The 48 newly published guidelines encompass a wide range of medical device fields, including diagnostic equipment, therapeutic devices, auxiliary equipment, rehabilitation equipment, and in vitro diagnostic reagents. These guidelines aim to provide clear standards and guidance for manufacturers in the registration process, enhancing the standardization of the medical device industry and ensuring product safety and effectiveness.

Here is the detailed list of the 48 medical device registration review guidelines released:

  • Guidelines for the Registration Review of Electric Photography Beds
  • Guidelines for the Registration Review of Medical Gas Alarm Systems
  • Guidelines for the Registration Review of Air-Oxygen Blenders
  • Guidelines for the Registration Review of Radiotherapy Laser Positioning Devices
  • Guidelines for the Registration Review of Intrabody Electrodes for Nerve and Muscle Stimulators
  • Guidelines for the Registration Review of Rehabilitation Training Beds
  • Guidelines for the Registration Review of Electroencephalograph Machines
  • Guidelines for the Registration Review of Medical Gynecological Gels
  • Guidelines for the Registration Review of Disposable Oxygen Masks
  • Guidelines for the Registration Review of Nebulizer Masks
  • Guidelines for the Registration Review of Bronchial Blockers
  • Guidelines for the Registration Review of Medical Catheter Fixation Devices
  • Guidelines for the Registration Review of Respiratory Masks
  • Guidelines for the Registration Review of Micro-manipulation Pipettes for Assisted Reproduction
  • Guidelines for the Registration Review of Electrolyte Analyzers
  • Guidelines for the Registration Review of Glucose Testing Reagents
  • Guidelines for the Registration Review of Gram-negative Bacteria Identification Reagents
  • Guidelines for the Registration Review of Pyruvate Testing Reagents
  • Guidelines for the Registration Review of α-Amylase Testing Reagents
  • Guidelines for the Registration Review of α-Hydroxybutyrate Dehydrogenase Testing Reagents
  • Guidelines for the Registration Review of Magnesium Testing Reagents
  • Guidelines for the Registration Review of Semi-automatic Chemiluminescence Immunoassay Analyzers (2024 Revision)
  • Guidelines for the Registration Review of Flow Cytometry Testing Reagents (Class I and II) (2024 Revision)
  • Guidelines for the Registration Review of X-ray Photography Machines (2024 Revision)
  • Guidelines for the Registration Review of Dental Treatment Units (2024 Revision)
  • Guidelines for the Registration Review of Medical Nebulizers (2024 Revision)
  • Guidelines for the Registration Review of Hearing Aids (2024 Revision)
  • Guidelines for the Registration Review of Magnetic Therapy Products (2024 Revision)
  • Guidelines for the Registration Review of Creatine Kinase Testing Reagents (2024 Revision)
  • Guidelines for the Registration Review of Coagulation Analyzers (2024 Revision)
  • Guidelines for the Registration Review of Medical Endoscope Light Sources (2024 Revision)
  • Guidelines for the Registration Review of Positive Pressure Ventilators (2024 Revision)
  • Guidelines for the Registration Review of β2-Microglobulin Testing Reagents (2024 Revision)
  • Guidelines for the Registration Review of Thyroid Stimulating Hormone Testing Reagents (2024 Revision)
  • Guidelines for the Registration Review of Ischemia-modified Albumin Testing Reagents Kit (2024 Revision)
  • Guidelines for the Registration Review of Lactate Dehydrogenase Testing Reagents Kit (2024 Revision)
  • Guidelines for the Registration Review of Glycated Hemoglobin Testing Reagents Kit (Enzymatic) (2024 Revision)
  • Guidelines for the Registration Review of Sialic Acid Testing Reagents Kit (Enzymatic) (2024 Revision)
  • Guidelines for the Registration Review of C-reactive Protein Testing Reagents Kit (2024 Revision)
  • Guidelines for the Registration Review of Peritoneal Dialysis Equipment (2024 Revision)
  • Guidelines for the Registration Review of Urine Analyzers (2024 Revision)
  • Guidelines for the Registration Review of Medical Image Storage and Transmission Software (PACS) (2024 Revision)
  • Guidelines for the Registration Review of Vibrating Percussive Devices for Sputum Clearance (2024 Revision)
  • Guidelines for the Registration Review of Large-scale Pressure Steam Sterilizers (2024 Revision)
  • Guidelines for the Registration Review of Triglyceride Testing Reagents (2024 Revision)
  • Guidelines for the Registration Review of Alkaline Phosphatase Testing Reagents (2024 Revision)
  • Guidelines for the Registration Review of Urine Sediment Analyzers (2024 Revision)
  • Guidelines for the Registration Review of Water Treatment Equipment for Hemodialysis (2024 Revision)

Enterprises and related departments can download the full text of the relevant guidelines through the official website of the CMDE of NMPA. These newly released guidelines will help enhance the overall quality standards of the medical device industry and ensure that patients have access to safe and effective medical device products.


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