As of October 2018, China has issued a total of 1,599 standards for medical devices, which basically cover the technical fields including medical electrical equipment, surgical instruments, surgical implants and other medical device products. All standards are under the administration of the Measures for the Administration of the Standards for Medical Devices.
Based on the range of application of the standards (i.e. the level of standard), they are divided into national standards and industry standards for medical devices, with 219 national standards accounting for 14% and 1,380 industry standards accounting for 86%.
Based on the effectiveness of the standards, they are divided into mandatory standards for medical devices, recommended standards for medical devices and guiding technical documents. Of which, 449 are mandatory standards, 1,148 are recommended standards and 2 are guiding technical documents. Among them, there are 87 mandatory standards, 130 recommended standards and 2 guiding technical documents in the national standards, 362 mandatory standards and 1,018 recommended standards in the industry standards.
