NMPA published 45 standards on September 7, 2023, to guide manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions. It includes 6 mandatory standards and 39 recommended standards.

Industry mandatory standards are legally enforced. Decree 739 Regulation on Supervision and Management of Medical Devices, the highest law governing medical device industry in China, mandates that “medical device shall meet the national mandatory standards; if there are no national mandatory standards, they shall comply with the industry mandatory standards”.

The industry recommended standards are not legally binding but recommended by regulatory authorities.

For English version of any standards below, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.

Mandatory Standards

• YY 0304-2023 Plasma sprayed hydroxyapatite coating titanium based dental implants
• YY 0306-2023 General technical requirements for thermal radiation treatment equipment
• YY 0451-2023 Disposable non-electrically driven portable infusion pump
• YY 0717-2023 Dentistry Root canal sealing materials
• YY 0852-2023 Disposable sterile surgical membrane
• YY 0875-2023 Surgical instruments linear staplers and components

Recommended Standards

• YY 1277-2023 Biosafety performance requirements for pressure steam sterilizers
• YY/T 0290.5-2023 Ophthalmic optics Intraocular lens Part 5: Biocompatibility
• YY/T 0466.1-2023 Medical devices Symbols used for information provided by manufacturers Part 1: General requirements
• YY/T 0675-2023 Ophthalmic instruments synopsis machine
• YY/T 0698.5-2023 Packaging materials for terminally sterilized medical devices Part 5: Sealable combination bags and rolls composed of breathable materials and plastic films Requirements and test methods
• YY/T 0767-2023 General technical requirements for color ultrasound imaging equipment
• YY/T 0773-2023 General technical conditions for ophthalmic B-mode ultrasonic diagnostic instruments
• YY/T 0841-2023 Medical electrical equipment Periodic testing and post-repair testing of medical electrical equipment
• YY/T 0851-2023 Medical anti-thrombotic socks
• YY/T 0905-2023 Dentistry central compressed air source equipment
• YY/T 0977-2023 Anesthesia and respiratory equipment oropharyngeal airway
• YY/T 1021.2-2023 Dentistry Tooth Extraction Forceps Part 2: Labeling
• YY/T 1021.3-2023 Dentistry Tooth Extraction Forceps Part 3: Design
• YY/T 1028-2023 Medical endoscope fiber endoscope
• YY/T 1622.2-2023 Dentistry Periodontal probe Part 2: Labeling
• YY/T 1833.4-2023 Artificial intelligence medical devices quality requirements and evaluation Part 4: traceability
• YY/T 1889-2023 Ophthalmic optics contact lens care products methods for assessing bacterial and fungal challenges of contact lens care products and contact lenses
• YY/T 1890-2023 Hepatitis B virus surface antigen detection kit (immunochromatographic method)
• YY/T 1893-2023 Y chromosome microdeletion detection kit
• YY/T 1895-2023 Intravascular optical coherence tomography imaging equipment
• YY/T 1900-2023 Dentistry corrosion resistance of dental amalgam
• YY/T 1901-2023 Requirements and test methods for orthopedic surgical navigation equipment using robotic technology
• YY/T 1905-2023 Dose calculation accuracy requirements for light ion beam radiotherapy plans
• YY/T 1906-2023 Disposable sterile closure clip
• YY/T 1907-2023 Artificial Intelligence Medical Devices Coronary CT Image Processing Software Algorithm Performance Test Method
• YY/T 1908-2023 Nucleic acid extraction instrument
• YY/T 1909-2023 Medical additive manufacturing metal powder bed electron beam melting process control and validation requirements
• YY/T 1910-2023 Medical beta-tricalcium phosphate powder for additive manufacturing
• YY/T 1911-2023 Coagulation test method for medical devices
• YY/T 1912-2023 Biological evaluation and testing of medical devices for soft tissue regeneration
• YY/T 1913-2023 Method for determination of 2,2-bis(4-hydroxyphenyl)propane (bisphenol A) residue in medical polycarbonate materials
• YY/T 1914-2023 General Requirements for Medical Devices and Devices for Human Assisted Reproductive Technology
• YY/T 1915-2023 General rules for laboratory testing of immunochromatographic kits
• YY/T 1916-2023 Interleukin 6 (IL-6) determination kit (labeled immunoassay method)
• YY/T 1917-2023 Anti-Xa determination kit (chromogenic substrate method)
• YY/T 1918-2023 Digital polymerase chain reaction analysis system
• YY/T 1919-2023 Ultrasound contrast imaging imaging performance test method
• YY/T 1920-2023 Dialyzer hemocompatibility test
• YY/T 1921-2023 Closed-loop copper-containing intrauterine device

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• Source: https://chinameddevice.com/nmpa-standards/