2, acceptance: the declaration of information submitted to the Food and Drug Administration Administration Hall. Upon review, the application belongs to the department's] scope of responsibility according to law, the declaration of information in line with the prescribed requirements, to be accepted, and issue a "Notice of Acceptance"
3, review and approval: the declaration of information for the first time, in accordance with the "Medical Devices Qualification Accreditation Rules for the Implementation of the Organization Acceptance"
4, publicity, certification, delivery: administrative license decision in the Food and Drug Administration website for publicity. Drug Administration website for publicity, while making and delivering the certificate to the applicant.
One, two types of medical devices manufacturing license process
1, application: the applicant with the declaration of information to the provincial, autonomous regions, municipalities directly under the Central People's Government of the People's Government of the drug supervision and management department to apply.
2, acceptance: the declaration of information submitted to the Food and Drug Administration administrative hall. Upon review, the application belongs to the department's] scope of responsibility, the declaration of information in line with the prescribed requirements, to be accepted, and issued a "Notice of Acceptance".
3, review and approval: the declaration of information for initial review, in accordance with the "Medical Device Business Qualification Accreditation Rules" organization acceptance.
4, publicity, certification, delivery: administrative licensing decisions in the Food and Drug Administration website for publicity, while making and delivering the certificate to the applicant.
Need to pay attention to the enterprise is to apply for a medical device license to the enterprise's operating place has certain requirements, the relevant departments] on the site requirements are very strict, and even the area of the site has certain requirements, the enterprise must be based on the requirements of the company to choose the appropriate registered address, otherwise the relevant department] to check the time to find that the enterprise address is unqualified, it is not possible to issue the enterprise medical equipment business license! The company has to choose the right address according to the requirements! The company will not be able to be trusted by its partners until it starts to operate its business after obtaining a medical device license.
Two, class medical device business filing certificate is valid
Valid for five years, the expiration of the validity of the need to renew the registration, should be in the validity of the expiration of six months before the renewal of registration to the original registration department to apply for renewal of registration.
According to the "supervision and management of the production of medical devices" in order to strengthen the supervision and management of the production of medical devices, standardize the production of medical devices, to ensure that medical devices are safe and effective. According to the "supervision and management of medical devices regulations" developed by the "supervision and management of medical device production measures" Article XIII "medical device production license" is valid for five years, set out the license number, enterprise name, legal representative, responsible person of the enterprise, residence, production address, scope of production, the issuance of licensing department, the date of issuance and validity of the period and other matters.
The process is likely to experience this department pushed to another department, if you do not understand the local situation, it is recommended to find a local consulting management company to handle, such as encountering unknown problems, feel free to consult the constant integrity.
Legal basis
"Supervision and Management of Medical Device Business"
Article 3 Engaged in the operation of medical devices, shall comply with laws, regulations, rules, mandatory standards and quality management standards for the operation of medical devices, and other requirements to ensure that the process of medical device business information is true, accurate, complete and traceable.
Medical device registrants, filers can sell their own, can also entrust the medical device business enterprises to sell their registered, filed medical devices.
Article IV in accordance with the degree of risk of medical devices, medical devices business implementation of classification management.
The operation of Class III medical devices license management, the operation of Class II medical devices for the record management, the operation of Class I medical devices do not require licensing and filing.