Question 2: What is the meaning of the medical device business scope of 68 "Medical Device Business License" business scope
Ⅲ:
6804 Ophthalmic Surgical Instruments
6815 Injection and Puncture Instruments
6821 Medical Electronic Instruments
6822 Medical Optical Apparatus, Instruments and Endoscopic Devices
6823 Medical Ultrasonic Instruments and Related Devices
6824 Medical Laser Instruments and Equipment
6825 Medical High Frequency Instruments and equipment
6826 Physical therapy and rehabilitation equipment
6828 Magnetic **** vibration equipment for medical use
6830 X-ray equipment for medical use
6832 High-energy radiation equipment for medical use
6833 Nuclide equipment for medical use
6840 Clinical testing and analysis instruments
6845 Extracorporeal circulation and blood processing equipment
6846 Implantable materials and artificial organs
6854 Operating room, emergency room, diagnostic and treatment room equipment and appliances
6858 Medical cold therapy, cryogenic, refrigeration equipment and appliances
6863 Dental materials
6864 Medical hygiene materials and dressings
6865 Medical Suture Materials and Adhesives
6866 Medical Polymer Materials and Products
6870 Software
6877 Interventional Devices
Question 3: What is the meaning of the display on the medical device? Where are the diagrams?
Question 4: What is the meaning of the medical device quasi-number 1, "State Drug Permit" is a pharmaceutical production units in the production of new drugs before the State Food and Drug Administration strict approval, the production of drugs approved by the number, equivalent to the human identity card. Its format is: State Drug License + 1 letter + 8 digits, of which the chemical drugs use the letter "H", Chinese medicine use the letter "Z" and so on. Only by obtaining this approval number can a drug be produced and sold. For historical reasons, in the past, the provincial drug authorities had the right to approve drugs, and some drugs used local approval numbers, such as "Beijing Wei Drug Permit", "Shanghai Wei Drug Permit", etc. These drugs were approved by the provincial and municipal drug authorities. These drugs are approved according to the local drug standards of each province or municipality directly under the central government, which is not conducive to the unified management of drugs by the State. In order to ensure the safety of clinical use of medicines, after 1999, the State upgraded the local drug standards to national drug standards, cleaned up and reorganized the medicines in the format of "X (Provincial) Health Drug Quarantine", and issued approval numbers of "State Drug Quarantine" for medicines that conformed to the national standards, and issued approval numbers of "Shanghai Health Drug Quarantine" for medicines that conformed to the national standards. The approval number of "State Drug Approval Certificate" is issued for drugs that meet the national standard, and drugs that do not meet the national standard are eliminated, while the authority to approve new drugs is transferred to the State Food and Drug Administration. In the current "Drug Administration Law", it is stipulated that the production of drugs "needs to be approved by the State Council's drug supervision and administration department, and issued with a drug approval number". Therefore, now if we find in the market "X Wei Drug Permit" and other non-"State Drug Permit" approval number of drugs, because it has passed the expiration date specified by the State Food and Drug Administration, can be regarded as fake drugs. Hundreds of people in the purchase of drugs, must carefully watch the approval number. Do not buy drugs without an approval number, or with a questionable approval number, so as not to buy fake drugs. State Drug Approval Code: The format of the drug approval number is "State Drug Approval (test) word + letters + 8 digits". Which "drug" on behalf of the drug, which is the most basic nature (and health food and medical device difference), "quasi" word on behalf of the state approved the production of drugs, "test" on behalf of the state The word "quasi" stands for drugs approved by the state, and "trial" stands for drugs approved for trial production by the state. Letters include H, Z, S, B, T, F, J, representing different categories of drugs: H for chemical drugs, Z for proprietary Chinese medicines, S for biological products, B for health care drugs, T for in vitro chemical diagnostic reagents, F for pharmaceutical excipients, and J for imported sub-packaged drugs. The 1st and 2nd digits of the 8-digit number represent the source of the original approval number, where 10 represents drugs approved by the former Ministry of Health; 19 and 20 represent drugs approved by the State Drug Administration; 11 Beijing, 12 Tianjin, 13 Hebei, 14 Shanxi, 15 Inner Mongolia Autonomous Region, 21 Liaoning, 22 Jilin, 23 Heilongjiang, 31 Shanghai, 32 Jiangsu, 33 Zhejiang, 34 Anhui, 35 Fujian, 36 Jiangxi, 37 Shandong, 41 Henan, 42 Hubei, 43 Hunan, 44 Guangdong, 45 Guangxi Zhuang Autonomous Region, 46 Hainan, 50 Chongqing, 51 Sichuan, 52 Guizhou, 53 Yunnan, 54 *** Autonomous Region, 61 Shaanxi, 62 Gansu, 63 Qinghai, 64 Ningxia *** Autonomous Region, 65 Xinjiang ** *** Autonomous Region. Xinjiang *** Autonomous Region. The third and fourth digits represent the last two digits of the AD year number in the year when the approval number was exchanged, but the approval numbers originating from the Ministry of Health and the State Drug Regulatory Administration still use the last two digits of the original year number. The 5th, 6th, 7th and 8th digits are the sequential number of the approval number. From January 1, 2003 onwards, "drug health word" products have stopped production, will be unified to use the State Drug Administration of the drug approval, the specification of the expression is as follows: health care drugs for the "State Drug Administration of the word B", the other drugs were: chemical drugs for the approval number "State Drug License H", biopharmaceutical "State Drug License S", Chinese patent medicine "State Drug License Z".
医加一站式医疗器械采购平台|医+
Question 5: What is the meaning of medical device product specifications Consumables are generally divided into specifications, such as the size of the surgical gown, the capacity of the syringe, the thickness of the infusion line, etc., and equipment is generally divided into models.
Question six: implanted medical devices What does it mean Hello, to introduce you to: Medical Device Classification Rules (Bureau Decree No. 15) (E) implanted medical devices: any with the aid of surgery, all or part of the device into the human body or natural cavities; in the end of the surgical process to remain in the body for a long time, or part of these devices remain in the body for at least 30 days or more, these devices are considered to be implanted devices.
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Question 7: What is the meaning of medical device MA Such generally appears in the X-ray equipment represents the current of the X-ray tube appears in other equipment basically stands for the current
Question 8: What is the meaning of DR in medical devices 10 points Specifically, we have to look at in which document information appears. In most cases DR refers to the digital X-ray imaging system, in addition, DR also means Device R for cord (medical device batch record), the former is more common.
Question 9: I would like to know what medical device this is? Through the structure can be seen is for the facial organs, the specific use is not known
Question 10: What does the word medical device license mean? Medical device permit word should medical device business license.
The opening of the second class of medical equipment business enterprises, should be to the provinces, autonomous regions, municipalities directly under the Central People's *** drug supervision and management department for the record; the opening of the third class of 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 the "medical equipment business enterprise license".