Release date: 2009-08-10
A few days ago, the official website of the European Union announced that the EU will introduce a new Medical Device Directive to improve the safety of medical devices. The new legislation puts basic requirements on the safety performance of medical devices in the following aspects.
1. To clarify the scope of “renovation and reuse of medical devices†and to define the definition and label of the term “one-time use†within the EU.
2. Manufacturers should try to avoid the use of substances that cause cancer, genetic mutations or harmful to reproduction (CMR) in medical devices. For example, manufacturers should identify the devices that may release phthalates; they should try their best to develop alternative substances or low-risk products.
3. According to the development of new technologies, specialized medical software will also be included in the new Medical Device Directive. The directive clearly states that software designed to diagnose or treat a patient can be viewed as a medical device, such as software used to help patients with cerebral hemorrhage; and general-purpose software for medical care is not a medical device. .
4. The problem of medical devices combined with human cells and tissues, the so-called "composite product" problem, is not a solution to this regulation. This issue will be addressed by other planned legislation, such as advanced therapeutic medicinal product regulations.
5. Due to the design of patient safety considerations, manufacturers should pay special attention to the working environment of product use and minimize the incidence of potential accidents. In the field of healthcare, medical devices are becoming more and more important, and the impact on health and health care costs is increasing.
Medical devices include more than 10,000 products, ranging from simple bandages and eyeglasses to life-sustaining implants to the most sophisticated diagnostic imaging equipment and minimally invasive surgical instruments, so the public is hoping that these medical devices will meet the highest safety standards. Performance standards.
The new directive has been updated based on the development of new technologies. The vote of the European Parliament was based on a compromise with the Council, which is expected to adopt some decisions immediately. Shanghai Medical Device Industry Association
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Dasatinib Intermediates
Dasatinib Api,Dasatinib Intermediates,Cas 302962-49-8
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