The old registration certificate format: the registration number is organized as follows: × (×) 1 (food) Drug Supervision and Measures (× 2) word ××××3 × 4 × 5 ××××6 No., which: × 1 for the registration and approval of the department of the location of the abbreviation: within the territory of the third class of medical devices, medical devices outside the country, as well as Taiwan, Hong Kong, Macao and the medical devices for the "country", "the word". The word "country".
Domestic Class II medical devices for the registration and approval department of the province, autonomous region, municipality directly under the Central Government for the abbreviation; domestic Class I medical devices for the registration and approval of the department of the province, autonomous region, municipality directly under the Central Government for the abbreviation of the municipal administrative region of the city where the abbreviation for × × 1 (without the corresponding municipal administrative region of the city, only for the abbreviation of the province, autonomous region, municipality directly under the Central Government).
×2 for the form of registration (quasi, into, allow): "quasi" word applies to the domestic medical devices; "into" word applies to foreign medical devices; "allow" word applies to Taiwan, Hong Kong, Macao and medical devices. The word "permit" applies to domestic medical devices; the word "import" applies to overseas medical devices; the word "permit" applies to Taiwan, Hong Kong and Macao medical devices; ××××3 is the year of approval for registration; ×4 is the product management category; ××5 is the product variety code; ××××6 is the registration number.
The certificate of registration of medical devices is accompanied by the "Registration Form for Medical Devices" (see Annex 1 of these measures), and the certificate of registration of medical devices used at the same time.
Expanded Information:
Medical devices are instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials, and other similar or related items used directly or indirectly in the human body, including the required computer software.
Utility is obtained primarily by physical and other means, not by pharmacological, immunological or metabolic means, or is involved but only in an ancillary manner.
Purposes are the diagnosis, prevention, monitoring, treatment, or alleviation of disease; the diagnosis, monitoring, treatment, alleviation, or functional compensation of injury; the examination, replacement, regulation, or support of physiological structures or processes; the support or maintenance of life; the control of pregnancy; and the provision of information for medical or diagnostic purposes through the examination of specimens from the human body.
Baidu Encyclopedia-Medical Devices