Medical device registrant filer is

Medical device registrant, the filer is to hold this medical device product (Class II, Class III) of the enterprise or other organizations, the filer is to hold this product (Class I) of the enterprise or other organizations. This in the device product registration certificate or record certificate will have the corresponding registrant, filer information (or can be queried through the State Drug Administration database).

Having this device product of this enterprise or organization to sell this product, you can not need to apply for business license or Class II business record certificate. But to comply with the supervision and management of medical devices regulations and medical equipment business quality management standard requirements.

If there is with the scale of operation and business scope of the business premises and storage conditions, as well as with the operation of medical devices and quality management system and quality management organizations or personnel.

Legal basis:

Regulations on the Supervision and Administration of Medical Devices

Article 103

The meaning of the following terms of this regulation:

Medical devices, refers to instruments, equipment, appliances, in-vitro diagnostic reagents and calibrators, materials, and other similar or related items used directly or indirectly for the human body, including the required computer software; the utility of which is obtained primarily by physical and other means, not by pharmacological, immunological or metabolic means, or which, although these means are involved, play only an auxiliary role; and which is intended for:

(i) the diagnosis, prevention, monitoring, treatment, or alleviation of disease;

(ii) the diagnosis, monitoring, treatment, alleviation, or functional compensation of injury;

(iii) the testing, substitution, regulation, or support of physiological structures or processes;

(iv) the support or maintenance of life;

(v) the control of pregnancy;

(vi) the provision of information for medical or diagnostic purposes through the examination of samples from the human body.

Medical device registrant, filer, refers to the acquisition of a medical device registration certificate or for the record of medical devices for the enterprise or research and development organization.