1. What kind of management system does my country implement for the production of medical device products?
my country implements a product manufacturing registration system for medical devices.
The production of Class I medical devices shall be examined and approved by the drug regulatory department of the people's government at the districted city level, and a product production registration certificate shall be issued.
The production of Class II medical devices shall be examined and approved by the drug regulatory department of the people's government of the province, autonomous region, and municipality directly under the Central Government, and a product production registration certificate shall be issued.
The production of Class III medical devices shall be examined and approved by the drug regulatory department of the State Council, and a product production registration certificate shall be issued.
2. What qualifications are required to operate medical device products?
The establishment of a first-class medical device business enterprise shall be filed with the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government. The establishment of Type II and Type III medical device operating enterprises shall be approved by the province, autonomous region,
The drug supervision and administration department of the people's government of the municipality directly under the Central Government reviewed and approved, and issued the "Medical Device Operating Enterprise License. Without the "Medical Device Operating Enterprise License", the administrative department for industry and commerce shall not issue a business license.
3. What requirements should medical device advertisements meet?
Medical device advertisements shall be reviewed and approved by the drug regulatory department of the people's government at or above the provincial level; without approval, they shall not be published, broadcast, distributed or posted.
The content of medical device advertisements shall be subject to the instructions for use approved by the drug regulatory authority of the State Council or the drug regulatory authority of the people's government of the province, autonomous region, or municipality directly under the Central Government.
4. Do medical devices need to go through clinical trials before they are marketed?
The clinical trials of medical devices are divided into clinical trials of medical devices and clinical verification of medical devices.
For medical devices that have not yet appeared on the market and whose safety and effectiveness have yet to be confirmed, clinical trials of medical devices need to be conducted before approval for marketing.
For medical devices of similar products that have been marketed and whose safety and effectiveness need to be further confirmed, clinical validation studies of medical devices shall be conducted before approval for marketing.
5. What are the contents of the medical device manual?
Medical device instructions should generally include the following content: product name, model, specification; manufacturer name, registered address, production address, contact information and after-sales service unit; "Medical Device Manufacturing Enterprise License" number (except for the first class of medical devices) , Medical device registration certificate number; product standard number; product performance, main structure, and scope of application; contraindications, precautions, and other warnings or reminders; explanations of graphics, symbols, abbreviations and other content used in medical device labels; Installation and use instructions or illustrations; product maintenance and maintenance methods, special storage conditions, methods; products used within a limited period of time should be marked with the expiration date; other content specified in the product standard that should be marked in the manual.
6. What content must not be included in the medical device manual?
The medical device instructions must not contain the following content: those containing assertions or guarantees of efficacy such as "best effect", "guaranteed cure", "inclusive cure", "radical cure", "immediate effect", "completely non-toxic and side effects"; Absolute language and expressions such as "the highest technology", "the most scientific", "the most advanced" and "the best"; indicate the cure rate or efficiency; compare with the efficacy and safety of other companies' products; contain " Commitment language such as "insurance company insurance", "invalid refund"; using the name or image of any unit or individual as a certification or recommendation; containing a medical device that makes people feel that they have a certain disease or misunderstands not to use the medical device Expressions that will suffer from a certain disease or aggravate the condition; other content prohibited by laws and regulations.
7. From a clinical point of view, how many types of medical equipment can be divided into equipment?
(1) Large-scale equipment, such as CT, MRI, PET/CT, DSA.
(2) Inspection and analysis equipment, such as: biochemical analyzer, blood cell counter, double-tube biological microscope, urine analyzer, microplate reader, plate washer, biological safety cabinet, ultra-clean workbench.
(3) Diagnostic equipment, such as: ultrasonic diagnostic equipment, various X-ray machines, and electrocardiographs.
(4) Critical emergency equipment, such as ventilators, anesthesia machines, and monitors.