A: The operation of a class of medical devices do not need a license, as long as there is a business registration.
The operation of Class II medical devices need to be filed with the municipal bureau, issued for the record vouchers.
The operation of Class III medical devices need to be licensed by the municipal bureau, issued by the license.
From October 1, 2014, the Medical Device Business License must be declared online and passed after on-site examination.
From the Food and Drug Administration website home page, "online business" section of the "medical device production and operation license filing information system" click to enter.
After entering the landing page, there is a special operation manual and tutorial video download interface, the applicant enterprise can download and use.
When applying for a license to file matters, in addition to completing the online declaration in the system, paper materials should also be submitted to the corresponding approval and filing departments before processing.
Note: 1. The business license is not allowed to apply for a medical device business license if it is not an enterprise and is an individual business.
(Individual) business license can be upgraded to the Business and Industry Bureau for business. The specific steps are: first to the industrial and commercial bureau of the industrial and commercial registration, fill in the form, and then take the relevant materials to the government hall for business license upgrade, upgrade to the enterprise, and then apply for the organization program code certificate, and then to the online declaration.
2. "Medical Device Filing Application Form" need to submit electronic materials, which add * for the required items.
The electronic material upload only supports the upload of pictures and pdf format materials.
1. * photocopy of the business license and organization code certificate
2. * legal representative, the person in charge of the enterprise, the person in charge of the quality of the identity, education or title certificate replica
3. * organization and departmental setting description
4. * business scope, business mode description
5. * business premises, warehouse Address of the geographic location of the map, floor plan, housing property rights certification file or lease agreement (with housing property rights certification file) photocopy
6.* business facilities, installations directory
7.* business quality management system, work programs and other files directory
8. Computer information management system basic information and functional description
9.* operator Proof of authorization
10. * Signed and stamped scanned application form
3. The difference between licensing and filing is that the license must have the 8th: computer information management system basic information and functional description, and computer management system.
Class III medical device license The enterprise is hair oh to apply for a health license?Consult the local administrative approval center drug monitoring window, Food and Drug Administration Medical Devices Division.
Class III medical device license required information mainly includes:
1, written application, signature (seal)
2, fill out the "Medical Device Business License Application Form" in triplicate
3, photocopies of the original and copy of the industrial and commercial business license or industrial and commercial pre-certification of the name book
4, the enterprise's internal institutional organization of the block diagram. Warehouse. Rational layout of the business premises (plan schematic); business address (location schematic).
5, enterprise legal representative, responsible person, quality management personnel qualification certificate (college), academic certificate, photocopy of ID card. Legal person, responsible for from the resume.
6, the appointment of business managers
7, the roster of employees (name, gender, age, education, title, position)
8, direct contact with medical equipment within the enterprise's personnel physical examination certificate information.
9, lease agreements, warehouse address recognition application. (More than two years)
10, the enterprise business varieties directory (name, specifications, manufacturers, registration certificate number, etc.)
11, the enterprise business products of valid certification information (product registration certificate, production, operation of enterprise license). Photocopies should be stamped with a red seal.
12, the enterprise should be based on their own actual situation to develop the following management system:
(1) business operations quality management system
(2) the first time the quality of the operating varieties of the audit system
(3) the return of the product management system
(4) the management of substandard products system
(5) the user access system
(6) health management system
(7) after-sales training, maintenance, service system
(8) quality acceptance, out of stock review system
(9) expiration date of the medical device management system
(10) special management of medical devices and valuable varieties of the management system
(11) the operation of Class III medical devices should be Develop quality tracking and adverse reaction reporting system
13, the business enterprise sales of products, the source and destination of clearly verifiable written assurance.
14, the applicant to provide information on the authenticity of the self-assurance declaration
15, enterprise legal person, responsible person, business address, warehouse and business product changes, should be timely to the applicant to re-apply for the Bureau
Medical Device Manufacturing License Class II Ting period for the requirements of
"Medical Device Manufacturing License" validity of the expiration of the continuation of the medical device manufacturer should be since the expiration of six months prior to the expiration of the validity period of the medical device manufacturer. The validity of the expiration of six months before the original issuance of the license to the Department of the continuation of the Medical Device Manufacturing License application.
The original licensing department shall, in accordance with the relevant provisions of the continuation of the application for review, on-site verification, if necessary, in the "Medical Device Manufacturing License" before the expiration of the validity of the decision on whether to grant the continuation. Meet the prescribed conditions, the continuation is granted. Does not meet the prescribed conditions, ordered to rectify; rectification still does not meet the prescribed conditions, not to continue, and a written explanation of the reasons. Late decision is not made, deemed to be granted the continuation.
New policy how to apply for a medical device license, Class II only need to record the systemArticle IV In accordance with the degree of risk of medical devices, medical devices business implementation of classification management.
The operation of the first class of medical devices do not require licensing and filing, the operation of the second class of medical devices to implement the record management, the operation of the third class of medical devices to implement the license management.
How much money to register two or three types of medical device license
First, the registration of medical equipment license without money, to the local department to apply, pay about 10 fees can be; start the second, third class medical equipment business enterprises, should be by the provinces, autonomous regions, municipalities directly under the Central People's *** drug supervision and management department for examination and approval, and issued a "medical device business enterprise license".
Second, the details can be reviewed:
:tieba.baidu./p/4396825437
Medical Device License Class III can operate the second class of products with the same code
You mean you have the same coding class of the third class of the business license, and now you want to operate the same kind of coding of the second class of medical devices is correct, right. This is not possible, class III and class II are separate, want to sell the second class or to go for the second class business record certificate only.
Medical device manufacturing license address change and product registration need to handle how many procedures? (Class I, Class II, Class III medical devices) What are the requirements for a Class II medical device manufacturing license, site?
The site can be divided into production area, storage area, office area, inspection area.
The site qualifications are 1, there is a real estate license (industrial or property nature, non-residential nature).
The area is compatible with the scale of production.
The environment around the production without major sources of pollution.
Look for Auzeda Medical Device Services Group!
This depends on the scope of your production license, if the classification code is the same, you can apply for a production license to increase the special case. This does not require the Drug Administration to verify.