Legal analysis: to the enterprise's location in the provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management department or accept the entrusted municipal (food) drug supervision and management agencies to apply for the "Medical Device Business Enterprise License".
Legal basis: "People's Republic of China *** and the State Administrative Licensing Law"
Article 12 The following matters can be set administrative licensing: (a) directly related to national security, public *** security, economic macro-control, ecological environmental protection, as well as a direct relationship with the health of the person, the safety of life and property, and other specific activities, which need to be approved in accordance with the statutory conditions; (b) limited Natural resources development and utilization, allocation of public **** resources and direct relationship with the public **** interests of specific industries, market access, etc., need to give specific rights; (c) the provision of public services and direct relationship with the public **** interests of the occupation, industry, need to determine the qualifications, qualifications with special credibility, special conditions, or special skills, etc.; (d) direct relationship with public **** safety, personal health, life and property safety of important equipment, need to be approved in accordance with the statutory conditions; (i) the public health, life and property safety of important equipment, and the public health, life and property safety of the public health, life and property safety of the public health, life and property safety , life and property safety of important equipment, facilities, products, goods, in accordance with technical standards, technical specifications, through inspection, testing, quarantine and other means of validation of matters; (e) the establishment of enterprises or other organizations, the need to determine the qualifications of the main body of the matter; (f) laws and administrative regulations can be set up for administrative licensing of other matters.
Article 29 Citizens, legal persons or other organizations to engage in specific activities, in accordance with the law need to obtain administrative licenses, shall submit an application to the administrative organ. The application requires the use of format text, the administrative organ shall provide the applicant with a format text of the application for administrative licenses. Format text of the application shall not contain content that is not directly related to the application for administrative licensing matters. The applicant may appoint an agent to file an application for administrative licenses. However, in accordance with the law should be made by the applicant to the administrative organ's office to file an application for administrative licenses, except. Administrative license application can be made by letter, telegram, telex, fax, electronic data interchange and e-mail.
Seventy-one violation of the provisions of Article 17 of this Law set the administrative license, the relevant organ shall order the setting of the administrative licensing authority to make corrections, or be revoked according to law.