On September 26th, the European Commission adopted a package that included two legislative recommendations and one notification. The program covers medical instruments, including in vitro diagnostics and active implantable medical instruments. The proposal for the new case is intended to replace the current medical device legislation in the European Union, namely Council Directive 90/385/EEC for Active Implantable Medical Devices and Council 93/ for other types of medical devices. Directive 42/EEC. The above legislation regulates medical devices intended to be placed on the EU market.

The new case involves several types of medical devices exported from China to the European Union, such as electronic devices such as heart rate monitors, blood pressure monitors and thermometers, as well as products such as tapes and plastic syringes.

In addition, the proposed programme proposes to develop a new regulation covering only in vitro diagnostic medical devices, thereby expanding the scope of the existing legislation. Products classified in this category include instruments to ensure blood transfusion safety and instruments used for blood chemistry analysis.

New, for example, passed, and the current legal framework will undergo major changes. The medical device legislation will be implemented directly in all EU member states and does not need to be transposed into national legislation.

The proposed scheme aims to overcome the deficiencies of the existing legislation, substantially tighten the EU medical instrument regulations, and propose more detailed regulatory and enforcement requirements for the conformity assessment bodies and the EU member states.

Market surveillance measures include: increasing the number of surprise inspections by conformity assessment agencies and EU member states; establishing an EU website, producers or importers are required to report serious incidents and corrective actions to the website; establish a single registration database (Eudamed) to ensure supply chain Every aspect of the journey can be traced.

The bill on medical devices adds new elements to the current legislation. The main points include: First, the necessary information about implantable medical devices must be provided to patients. This means that producers and importers are responsible for providing such information. Examples of such instruments are implantable cardiac pacemakers, catheters, and implantable active monitors. Second, the source and destination of medical instruments will be easier to trace. The legislative approach ensures that medical device users can trace back to where and to whom the instrument is supplied when necessary. The third is the implementation of the Special Equipment Identification (UniqueDeviceIdentification) regulations, manufacturers, representatives or importers must register the information of their own medical instruments with the Central European database, and must disclose the instrument safety and performance information. Fifth, the new legislation emphasizes the importance of clinical evaluation. It is the responsibility of the manufacturer to ensure that the product has been clinically evaluated prior to its launch into the market and that the results of the evaluation must be made public and that the product must be followed up after it is launched into the market. Sixth, another new element introduced by the future legislation is “qualified persons”. The manufacturer must appoint a qualified person to ensure that the product complies with the regulations. The person must have medical instrument expertise to ensure that each batch of product has been evaluated before it is released to the market and that the technical documentation and conformity statement documents are properly maintained.

The bill also recommends that in the absence of harmonized standards, common technical specifications should be introduced. Under the current legislation, only the common technical specifications for in vitro diagnostic medical devices, the introduction of common technical specifications for manufacturers outside the in vitro diagnostic medical instrument industry will be a new measure.

Compared with the current legislation, the proposed medical device regulations are more widely regulated. The new case will cover a wide range of products that are not regulated by the current legislation, such as products made from nanomaterials ranging from 1 to 100 nanometers, replacement parts that can significantly change the characteristics of the instrument and are themselves instruments.

The proposed proposal must be submitted to the European Parliament and the Council of the European Union for consideration. The Parliament and the Council may propose to amend the bill, or it may take a year or two to reach a consensus. After the bill is passed, it will be published in the Official Gazette and will take effect three years later. Therefore, manufacturers will have some time to make adjustments to meet the new regulations.

Amoxicillin Injection

Antibiotics. Amoxicillin has strong bactericidal effect and strong ability to penetrate cell wall. It is one of the widely used oral penicillins. Its preparations include capsules, tablets, granules, dispersible tablets and so on. Penicillin allergy and penicillin skin test positive patients are prohibited.
pharmacological action
Amoxicillin is a semi synthetic broad-spectrum penicillin. Its antibacterial spectrum and antibacterial activity are basically the same as ampicillin, but its acid resistance is stronger than ampicillin, and its bactericidal effect is stronger and faster than ampicillin, but it can not be used in the treatment of meningitis. The half-life is about 61.3 minutes. Amoxicillin is stable under acidic conditions, and the gastrointestinal absorption rate is up to 90%, which is more rapid and complete than ampicillin. Except that the effect on Shigella is worse than ampicillin, the other effects are similar.
Amoxicillin has strong bactericidal effect and strong ability to penetrate cell wall. After oral administration, the lactam group in the drug molecule immediately hydrolyzes to form peptide bonds, which quickly combines with transpeptidase in the bacteria to inactivate it, cutting off the only way for the bacteria to synthesize glycopeptides by transpeptidase to build the cell wall, making the bacterial cells quickly become spherical and break and dissolve, and the bacteria eventually burst and die due to the loss of cell wall and continuous penetration of water. It has strong bacteriostatic and bactericidal effects on most pathogenic G + bacteria and G-bacteria (including cocci and bacilli). Among them, there is no production of aerobic Gram-positive cocci such as Streptococcus pneumoniae and hemolytic streptococcus, Staphylococcus without penicillinase and Enterococcus faecalis, and aerobic gram-negative bacteria such as Escherichia coli, Proteus mirabilis, Salmonella, Haemophilus influenzae and Neisseria gonorrhoeae β Lactamase strains and Helicobacter pylori have good antibacterial activity. Hemodialysis can remove some drugs, but peritoneal dialysis has no effect on removing this product.
Sensitive bacteria: Streptococcus A, B, C, F, G and non grouping, Listeria monocytogenes, diphtheria, Neisseria meningitidis, pertussis, Clostridium perfringens, Propionibacterium, digestive Streptococcus, Streptococcus bovis, Salmonella, eubacteria, actinomycetes, leptospira and Treponema pallidum.
Unstable sensitive bacteria: penicillin sensitive or drug-resistant pneumococci, Enterococcus faecalis, Escherichia coli, Proteus mirabilis, Shigella, Vibrio cholerae, Haemophilus influenzae, Neisseria gonorrhoeae and Clostridium.
Drug resistant bacteria: Staphylococcus, catarrhal bacteria, Klebsiella acidogenes, Klebsiella pneumoniae, Proteus vulgaris, Pseudomonas, Acinetobacter, Campylobacter, veronicus, mycoplasma, Rickettsia, Legionella, Bifidobacterium and fragile bacteria.
Toxicology: unclear [4].
indication
Amoxicillin can be used to treat typhoid, other Salmonella infections and typhoid carriers. Treatment sensitive bacteria do not produce β The urinary tract infection caused by lactamase strains also obtained good curative effect. For patients with lower urinary tract infection and enzyme-free Neisseria gonorrhoeae urethritis and cervicitis, a single oral dose of 3G can obtain satisfactory curative effect. Streptococcus pneumoniae, penicillinase producing Staphylococcus aureus, hemolytic streptococcus and penicillinase producing Staphylococcus aureus β Ear, nose and throat infections, respiratory tract infections and skin and soft tissue infections caused by Haemophilus influenzae with lactamase are indications. Amoxicillin can also be used for leptospirosis. This product can also be used for urogenital infection caused by sensitive Escherichia coli, Proteus mirabilis and Enterococcus faecalis. This product has good curative effect on Helicobacter pylori infection in combination with clarithromycin and lansoprazole.
Amoxicillin is suitable for sensitive bacteria (not producing β- The following infections caused by lactamase strains):
(1) Upper respiratory tract infections such as otitis media, sinusitis, pharyngitis and tonsillitis caused by Streptococcus haemolyticus, Streptococcus pneumoniae, Staphylococcus or Haemophilus influenzae;
(2) Urogenital tract infection caused by Escherichia coli, Proteus mirabilis or Enterococcus faecalis;
(3) Skin and soft tissue infection caused by hemolytic streptococcus, Staphylococcus or Escherichia coli;
(4) Acute bronchitis, pneumonia and other lower respiratory tract infections caused by Streptococcus haemolyticus, Streptococcus pneumoniae, Staphylococcus or Haemophilus influenzae;
(5) Acute simple gonorrhea;
(6) It can be used to treat typhoid, other Salmonella infections, typhoid carriers and leptospirosis; Amoxicillin can also be combined with clarithromycin and lansoprazole to eradicate Helicobacter pylori in stomach and duodenum and reduce the recurrence rate of gastrointestinal ulcer.

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