Application information required: 1. Manufacturer of medical equipment issued by the reasons for the replacement of the certificate and the situation. Which should include the original certificate of conformity of the manufacturer's statement of the loss of the published notice: the original newspaper and stamped copies (published in the newspaper should be more than the provincial level for the public circulation of the newspaper).
2. Producer qualification documents: business license and a copy of the manufacturer's license.
3. Within the validity period of the medical equipment certificate of conformity and a copy of the annex or the original certificate of conformity of the certificate number.
4. A copy of the identity card of the person in charge of the production enterprise (when the person in charge of the production enterprise); or the production enterprise issued by the enterprise registration application for a letter of authorization to deal with the affairs of the person and a copy of the identity card of the person who dealt with the application (non-producer for the person in charge of the production enterprise).
5. Production enterprises to submit information on the authenticity of the self-assurance statement: including the list of information submitted and the commitment of the manufacturer to assume legal responsibility.
Medical equipment refers to the use of the human body alone or in combination of instruments, equipment, appliances, materials or other items, including the required software. Medical equipment is the most basic elements of medical care, scientific research, teaching, institutions, clinical disciplines work, that is, including professional medical equipment, but also includes home medical equipment.