What is the composition of the first class of medical device record certificate?
The Class I medical device filing credentials include: "Class I Medical Device Filing Credentials" and "Class I Medical Device Production Filing Credentials"
The Class I Medical Device Filing Credentials is the product's proof of approval, equivalent to the product's ID card, with this credentials, the product will also have the legal qualifications for registration.
"Class I medical device production record voucher" is the product is allowed to produce proof of approval, equivalent to the production license of the enterprise, if there is no such voucher, the enterprise can not produce the product.
What is needed for the filing of Class II medical devices?
1. A copy of the business license and organization code certificate. (If the company is not yet registered on the company registration process, do a good company license and then do the Class II medical device business filing certificate can be)
2. Legal representative, the person in charge of the enterprise, the person in charge of the quality of the identity of the person in charge of a copy of the certificate of qualifications or professional title. (Conditions are not met, it's okay, looking for lean)
3. Organizational structure and departmental setup description. (If not, please contact us)
4. Description of business scope and mode of operation. (If not, please contact us)
5. Business premises, warehouse address geographic location map, floor plan, documents proving property rights or lease agreement (with documents proving property rights) copy. (If not, please contact us)
6. Business facilities, equipment catalog.
7. Catalog of business quality management system, work procedures and other documents.
8. Proof of authorization of the operator.
9. Other supporting materials.
How do the device package for the record of a class of medical devices?
It is not a class of medical devices can be written directly in the scope of business sales, a class does not need to be filed.
Class II filing, Class III license
Oral medical device product design and packaging need to be filed?
Product packaging design does not need to record. Product packaging design, the need for professional packaging design organizations to go for, do not have to carry out industrial and commercial record. Industry and commerce for the record is to handle market access to engage in business activities and legal documents. Product packaging design does not belong to the industrial and commercial matters for the record, is the company's own product design behavior, without industrial and commercial record.
A class of medical devices for the record process?
The first class of medical device products for the record, by the filing of the municipal people's government in charge of drug supervision and management of the location of the municipal people's government to submit the 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, 1 photocopy)
3. Product Technical Requirements (1 electronic copy, 1 copy)
4. Electronic 1, a copy of 1)
5. Clinical evaluation information (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 basis: "Regulations for the Supervision and Administration of Medical Devices"
Legal basis: "Medical Devices Supervision and Administration"
The first class of medical devices shall be implemented in accordance with Article 13 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, the safety and effectiveness of the responsibility according to law.