Class I medical device filing process?
The first class of medical device products for the record, by the filer to the location of the municipal people's government responsible for drug supervision and management of the department 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 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 of the development, production, operation, use of the whole process of medical devices, safety, effectiveness and bear responsibility according to law.
Medical device health care record management?
The state supervision of medical devices and health products is very strict. Medical devices and health care products, you must go to the provincial market supervision administration for the record.
And Zhejiang Province since September 1, 2020 onwards, no longer handle foreign drugs, medical devices, health food advertising to Zhejiang Province before the release of the record.
Medical equipment business query entrance?
In the State Drug Administration website query, open the "medical device" section: (/ylqx/index.html)
Tap the link to enter the site, you will see the right side of the page there is a medical device query portal. Don't be in a hurry to click on which to enter, you should first determine their own query of medical equipment products are imported or domestic, if domestic on the point of "domestic devices", if imported, click on the "imported devices". You can check the record information.
How do I file a Class I medical device for a device kit?
A class of medical devices is not directly written in the business scope of sales, a class does not need to record.
Class II filing, Class III approval license
Class I, Class II, Class III device filing and licensing instructions?
One class: no medical device license
The first class of medical devices is a low degree of risk, the implementation of routine management can ensure the safety and effectiveness of medical devices, such as scalpels, surgical scissors, manual beds, medical ice packs, cooling patches, and so on, the products and production activities by the location of the municipal food and drug regulatory authorities to implement the management of the record. Business activities are all liberalized, neither permit nor record, only need to obtain a business license issued by the business sector.
Class II: Municipal Food and Drug Administration for medical equipment business preparedness
Class II medical devices is a medium risk, need to strictly control the management to ensure its safety and effectiveness of medical devices, such as band-aids, condoms, thermometers, blood pressure monitors, oxygen concentrators, nebulizers, etc., common in our daily lives, its products and production activities by the provincial food and drug regulatory departments to implement licensing management, respectively, issued the "Medical Device Registration Certificate", "Medical Device Registration Certificate", "Medical Device Registration Certificate", "Medical Device Registration Certificate", "Medical Device Registration Certificate" and "Medical Device Registration Certificate". Issued respectively to the "Medical Device Registration Certificate" and "Medical Device Manufacturing License". Business activities by the municipal food and drug regulatory authorities to implement record management.
Requirements for Class II Medical Devices
1, 45 square feet of storage, including 15 square feet of office space
2, a medical professional as the person in charge of the enterprise
3, the product business directory
Note: In line with the above 3 points, basically can be processed for the record of the second class of medical devices.
Class III: State Drug Administration for medical device license
Class III medical device refers to the implantation of the human body, used to support, maintain life, potentially dangerous to the human body, its safety, effectiveness must be strictly controlled medical devices. Therefore, the state control in this area is very strict, then for a class, class II, a class due to the low degree of risk, only need to apply for an ordinary company on the line, class II has a medium risk, so it is also necessary to do a filing.
The third class of medical devices is a higher risk, need to take special measures to strictly control the management to ensure its safety and effectiveness of medical devices, such as common infusion sets, syringes, intravenous needles, cardiac stents, respiratory machines, CT, nuclear magnetic **** vibration, etc., its products and production and operation activities, respectively, by the State General Administration of the food and drug regulatory departments at the provincial level and the municipal food and drug regulatory department of the district The implementation of licensing management, respectively, issued by the "Medical Device Registration Certificate", "Medical Device Manufacturing License", "Medical Device Business License".
For three types of medical device license requirements:
1. Address requirements: general class: office area of not less than 100 square feet, warehouse area of not less than 60 square feet;
2. disposable sterile: office area of not less than 60 square feet, warehouse area of not less than 80;
3. in vitro diagnostic reagents: office area of not less than 60 square feet, warehouse area of Not less than 100 square feet, cold room area of not less than 40 cubic
4. Personnel requirements: three bachelor's degree related medical industry.
For three types of medical equipment license notes:
1, office address needs to be commercial nature, the area of the building area on the real estate license shall prevail;
2, in vitro diagnostic reagents must have a cold room, and 40 cubic meters, medical freezers are useless, it must be a cold room; as it relates to the follow-up teacher to the site survey;
3, three personnel Must be undergraduate medical industry, follow-up for the three types of medical device license, the teacher over there to interview, so this personnel is very important, can not rely on, the annual inspection also involves these three personnel, so the most important for the three types of medical device license is the personnel, the address does not have our XunLing enterprise services can provide, but the personnel can not provide.
4, the company's business license on the registered address needs to be consistent with the actual office address, such as the business license address is the park address, then you need to migrate to the actual office address, or the address we provide, because not every park address can increase the scope of business related to the three types of medical devices, without the scope of this business will not be able to apply for a license for the three types of medical devices;
5, There must be its sales of three types of medical equipment product registration certificate, there is this certificate, in order to determine the three types of medical equipment is qualified regular, subsequent application for three types of medical equipment license,, submit materials, this product registration certificate is one of the most important materials.