What conditions are required for a class of production license filing?
The first class of medical device product filing requirements and processes: first of all, the filer to the location of the municipal people's government food and drug supervision and management department to submit the filing information.
Which, the product inspection report can be the filer's self-inspection report; clinical evaluation information does not include clinical trial report, can be through the literature, the data obtained from the clinical use of similar products to prove that the medical device is safe and effective information.
Overseas manufacturers exporting Class I medical devices to China shall submit to the Food and Drug Administration under the State Council the filing information and the documents certifying that the competent authorities of the country (region) where the filer is located have authorized the marketing of the medical device by the representative organization established in China or by designating an enterprise legal person in China as the agent.
Certification for the sale of Class I medical devices?
There must be a business license to operate, the sale of a class of medical equipment commodities of individual businessmen need to apply to the local industrial and commercial bureau for a business license procedures to obtain a business license and then go to the local health bureau to apply for a health permit, in addition to the local tax bureau to apply for a tax registration certificate to the local public security organs to apply for the police station for the special industry license
Medical consumables three certificates? p>What are the three certificates for medical supplies?
The three medical device certificates refer to: medical device product registration certificate (including a class of production record certificate, two or three types of registration certificate), medical device production license and medical device business license (including two types of business record and three types of business license).
What is the validity period of a Class I filing information sheet?
The validity period of the Class I medical device registration certificate is the same as that of the medical device registration certificate, which is valid for 5 years.
The filing of Class I medical device refers to the handling of Class I medical device product certificates in accordance with the relevant requirements of the Regulations for the Supervision and Administration of Medical Devices, which is equivalent to the product's ID card for identifying the product's name, use, description, expiration date, etc., as well as the manufacturer, commissioned by the manufacturer, etc., to prove that the product has been filed by the drug supervision and management authorities and has the force of law.
Filing refers to the registrant to submit the product filing materials, make relevant commitments, and the filing of the authenticity of the materials, integrity and compliance is responsible for; market supervision and management department shall file the filing materials submitted by the filer to meet the requirements of the form of examination for the record.
One class of medical devices for the record charges?
A class of medical devices for the record does not charge. After the reform of the registration system, for a class of medical devices for the record, the record of the registration authority will no longer charge any fees, the state has canceled the registration of all kinds of administrative fees.
As long as a class of medical equipment operators to submit the record materials are complete, after the audit, the record authorities will be a class of medical devices for the record registration, no charge. Therefore, a class of medical devices for the record without charge.