NMPA issued the “list of mandatory standards applicable to medicals” on November 11, 2022, directing manufacturers for type testing and regulatory submission. Over 400 mandatory national and industry standards are included.
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”.
For an English version of the standards list, please email [email protected]. We charge nominal fees for the translation.
The Device List
The list is categorized by devices referring to the NMPA Medical Device Classification Catalog. Oftentimes, multiple mandatory national and industry standards may apply to each device.
The devices include but not limited to the following:
- Laser surgery equipment
- High-frequency surgical equipment
- Radio frequency ablation equipment
- Argon protects coagulation equipment
- Electrodes and catheters for high frequency/radio frequency
- Perfusion pumps for RF ablation equipment
- Microwave surgical equipment
- Electric stapler
- scalpel
- Stapler (with nails)
- Stapler (without nails)
- Absorbable sutures
- Non-absorbable sutures
- Contrast catheter
- Guide tube
- Central venous catheter
- Perfusion catheters
- Balloon dilation catheter
- Thrombus suction catheter
- Trocar peripheral catheter
- Guide sleeve
- Catheter sheath
- Dilator
- Guidewire
- Microcatheters
- Medical electron accelerator
- Medical light ion therapy system
- Medical X-ray treatment equipment
- Gamma beam teletherapy machine
- Close-up rear treatment equipment
- Radioactive seeds implanted into the treatment system
- Radiation therapy simulation system
- X-ray image guidance system for radiation therapy
- Radiation Therapy Stereotactic System
- Collimation confinement device blood vessels
- Contrast X-ray machine
- … …
General Standards
Sixteen general mandatory standards with wider applications are also published
- Safety requirements for electrical equipment for measurement, control and laboratory use Part 4: Special requirements for sterilizers and washer-disinfectors for handling medical materials
- Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Parallel standard: electromagnetic compatibility Requirements and tests
- Medical Electrical Equipment Part 1-8: General Requirements for Basic Safety and Basic Performance Parallel Standards: General Requirements, Testing and Guidelines for Medical Electrical Equipment and Alarm Systems in Medical Electrical Systems
- Medical Electrical Equipment Part 1-11: General Requirements for Basic Safety and Essential Performance Tied Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in Home Care Environments
- Medical Electrical Equipment Part 1-12: General Requirements for Basic Safety and Basic Performance Tied Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Expected to Be Used in Emergency Medical Services Settings
- Medical electrical equipment Part 1-3: General requirements for basic safety and basic performance Parallel standard: radiation protection for diagnostic X-ray equipment
- Surgical implants Metal Materials Part 1: Forged stainless steel
- Surgical implants Metal Materials Part 4: Casting cobalt-chromium-molybdenum alloys
- Surgical implants Metal materials Ti-6Al-7Nb alloy processing materials
- Surgical implants Metal Materials Part 9: Forged high nitrogen stainless steel
- Surgical implants Metallic materials Part 12: Forged cobalt-chromium-molybdenum alloys
- Surgical implants Hydroxyapatite Part 1: Hydroxyapatite ceramics
- Surgical implants Hydroxyapatite Part 2: Hydroxyapatite coatings
- Passive surgical implants Bone joint and spinal implants Part 1: Special requirements for bone joint implants
- Passive surgical implants Bone joints and spinal implants Part 2: Special requirements for spinal implants
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- Source: https://chinameddevice.com/nmpa-mandatory-standards/