How to file a class I medical device license?
The first class of medical device products for the record, by the filer to the location of the municipal people's government in charge of drug supervision and management of the department responsible for filing information.
Processing materials in general:
1. "Class I Medical Device Filing Form" (the original original (collected) 1, 1 electronic copy)
2. safety risk analysis report (1 electronic copy, a copy of 1)
3. product technical requirements (1 electronic copy, a copy of 1)
4. product testing report ( Electronic 1, a copy of 1)
5. Clinical evaluation data (electronic 1, a copy of 1)
6. Product manuals and minimum sales unit labeling design samples (electronic 1, a copy of 1)
7. Manufacturing information (electronic 1, a copy of 1)
8. Supporting documents (copy of business license, copy of organization code certificate) Organization code certificate copy) (1 electronic, 1 copy)
9. Declaration of conformity (original original (collected) 1, 1 electronic)
10. Proof of authorization of the operator and the operator's original identity card and a copy of the original (original original (collected) 1, 1 electronic)
Legal authority: "Regulations for the Supervision and Administration of Medical Devices"
Legal authority: "Regulations for the Supervision and Administration of Medical Devices"
Lawful basis: "Medical Device Supervision and Administration"
The first class of medical devices shall be implemented in accordance with Article XIII of the Regulations. Article XIII of the first class of medical devices to implement the product record management, the second class, the third class of medical devices to implement product registration management.
Medical device registrants, filers should strengthen the quality management of medical devices throughout the life cycle, the development, production, operation, use of the whole process of medical devices, safety, effectiveness and bear responsibility according to law.
In Taobao for Class II medical device qualification record?
Two medical device qualification record, not the local business license.
Two different documents, the first business license is a must for business documents, and then because it is a medical device special industry needs to be registered for the record.
Engaged in the second class of medical equipment business, business enterprises should be located in the municipal food and drug supervision and management department for the record, fill out the second class of medical equipment business filing form, and submit the following information:
1. Business license and a copy of the organization code certificate.
2. Legal representative, the person in charge of the enterprise, the quality of the person in charge of the identity card, education or title certificate copy.
3. Organizational structure and departmental settings.
4. Description of the business scope and mode of operation.
5. Business premises, warehouse address of the geographic location map, floor plan, documents proving property rights or lease agreement (with documents proving property rights) copy.
6. Business facilities, equipment catalog.
7. Business quality management system, work procedures and other documents catalog.
8. Proof of authorization of the operator.
9. Other supporting materials.
References
The second class of medical devices for the record
. Class II medical device filingWhat do you need a diploma for medical device filing?
The need for a college degree certificate in the medical field.
Medical device filing refers to the medical device filing (hereinafter referred to as the filing) in accordance with the statutory procedures and requirements to the drug supervision and management department to submit the filing information, drug supervision and management department of the filing of information submitted for the record of the activities.
Materials required for the first filing of Class I medical device products;
1. Class I Medical Device Filing Form
2. Safety Risk Analysis Report
3. Product Technical Requirements
4. Product Inspection Report
5. Clinical Evaluation Information
6. Product Specifications and Minimum Sales Unit Label Design samples
7. Manufacturing information
8. Business license (Class A Limited Liability Company)
9. Declaration of Conformity (Declaration of Conformity should include: a) Declaration of compliance with the requirements for the record of medical devices; b) Declaration that the product complies with the contents of the catalog of Class I Medical Devices or in vitro diagnostic reagents classified subdirectories; c) Declaration that the product complies with the current national standards, industry standards and provide a list of compliant standards; d) Declaration of the authenticity of the submitted filing information.)
10. Catalog of application materials
11. Authorization letter
How to apply for medical device filing certificate?
1.
Online application. The applicant should be submitted online pre-approval of the application, the enterprise in the submission of paper application materials must be submitted at the same time the pre-acceptance number;
2.
Window acceptance. Enterprises to submit paper applications to the window, receiving and accepting personnel to verify the application materials, on the spot to make a decision on acceptance;
3.
On the spot review. Accepted, the reviewer to review the material, make a decision on the spot review;
4.
Collect the results. Applicants in the window on the spot to receive the "production of Class I medical devices for the record voucher" or "do not pass the decision".
How many types of medical device sales need to be registered?
Domestic sales of Class II medical devices need to be filed for registration, sales of Class III need a license, sales of Class I have no special requirements. First of all, you have to look at your business belongs to several categories, a class of medical devices only need to be mentioned in the business license, class II medical devices need to operate for the record, class III medical devices only need to operate the license, if it is a class II: the need for quality of the person in charge of after-sales personnel, class III: the scope of the business license with the sale of medical equipment, and also need to have a quality of the person in charge of the person in charge of after-sales, the implantation of the intervention plus a salesman. An inspector, 2 inspectors, and of course the personnel to survey the site. The category is different, the need is also different, do not understand if you can also communicate with each other