A Shortcut to FDA 21 CFR Part 11 Compliance
Many suppliers in China are confused by the FDA requirements. This has further added to the headaches when overseas sourcing professionals are trying to identify suppliers that are FDA compliance. In the FDA maze, FDA 21 CFR Part 11 -- Electronic Records; Electronic Signatures -- (Part 11) has generated quite a bit of press. For those who are unfamiliar with the requirement, I recommend a quick and brief review of the FDA guidance located in the public domain. In short, FDA has dictated the use of the Part 11 guidance in March, 1997. Under widespread scrutiny by the industries, stating that the original guidance may not be consistent with FDA's original intent in issuing the rules, and other factors...
Is Your Pharmaceutical Company GMP...
Nothing is more reassuring than a pharmaceutical company that is GMP manufacturing compliant. GMP, or Good Manufacturing Practice, is a system of checking the way the food and pharmaceutical companies manufacture their products from the time they are formulated until they are distributed to retail stores. Manufacturing companies, especially those that manufacture drugs, are expected to comply with this internationally recognized quality control system. This way, consumers are assured that the products that they are getting will be effective and safe for human consumption. As a quality assurance system that has been initiated and promulgated by the US Food and Drug Administration (FDA) under the...
With the aid of advanced technologies, innovative devices have been introduced in the medical field. These medical devices have been broadly classified as medical disposables, surgical equipment, diagnostic equipment, laboratory devices and diagnostics, dental equipment, and ophthalmic equipment. According to TechNavio, the market for Medical devices in China is forecast to reach $25,770.9 million by 2013 from $16,677.0 million in 2009, growing at a CAGR of 11.5 percent over the forecast period. Rapidly growing technology, increasing demand for innovative medical devices together withaging population and prevalence of chronic illness are very important growth drivers for the medical devices market...
For any business in the medical and pharmaceutical industry, it is an essential requirement to keep up-to-date with the latest regulations and comply with Good Manufacturing Practice guidelines or GMP compliance. GMP compliance is a means through which all companies in this industry are able to maintain quality whilst proving to be effective in the bigger business of saving people's lives through healthcare and quality treatments. Across the world, different government and official regulators enforce GMP compliance in different ways, but usually this is done using statutes in law. In the US, the Food and Drug Agency enforces GMP compliance as part of its official remit, whilst in the UK, the...
The medical devices patent wars are raging and competing against those of the pharmaceutical industry. The situation for the medical devices patenting fraternity gets worse with the distinguished importance gathering towards the design patents. The recent decision by the U.S. Court of Appeals for the Federal Circuit makes the design patents even more valuable than the process patents. That is to say, the complexity associated with the medical devices patent community in order to maintain the competitive edge for their respective companies is manifold. However, it is certainly a no brainer to visualize this scenario if perceived from the barriers to competition (regulatory approval, reimbursement...
The Basics of Medical Manufacturing Services...
Are you interested in medical manufacturing services or medical device development but have no idea what it is about or whether it can help you? Just learning the basics of how the process works can give you great insight as to what kinds of services these companies offer and whether they are an option worth looking into for yourself. Medical device development companies make it their job to turn a design concept into a physical and functional product. If an inventor has an idea for a new device, they often seek medical manufacturing services in order to receive professional guidance and assistance with making sure their medical device is successful once it is introduced into the market. First the...
August 1, the "drugs and Shenyang Medical Devices Supervision and management measures "into effect. This is the first nationwide local government introduced drugs and medical equipment to government regulations. 8 1st, Shenyang Food and Drug Administration held a "implementation of the" Shenyang Pharmaceutical and Medical Devices Regulations "to ensure Austrian Cup in Shenyang drugs and medical devices safe" activities. Shenyang Food and Drug Administration approval system interpretation of the relevant person in charge "approach." More than 20 food and medicine safety of the community hot spot "approach", have indicated that a more in-depth study "approach", and so carry out social supervision...
FDA Compliance Ensures Safety of Medical Devices
There are many kinds of medical devices that are used being used across the world in order to treat patients for a vast array of medical conditions. Medical devices are kept safe in the US by the imposition of FDA compliance - a set of regulations and standards designed to protect consumers and patients. FDA compliance is run by the Food and Drug Administration Agency of the US Federal Government and regulates a whole host of areas that affect many people daily. The products and areas they regulate are the safety and nutritional benefits of food substances and the labelling of dietary supplements, ensuring that the drugs industry provides proves that new medicines are safe and tested according to...
Semiconductor Technology in the Medical Devices...
ration of biological and medical electronic equipment, electronic technology has become an important disease prevention, clinical treatment, patient care and personal health care and medical aid, so that the semiconductor technology in medical electronics applications shine. Global population growth and population aging accelerates, rising health care costs, and rapid economic development and health awareness becomes stronger, also keep consumers to consider new medical electronic equipment needs to increase. Health care products to become the post-PC products and communication equipment semiconductor company effort to build another revolutionary technology applications. According to statistics, the...
Promote the use of cardiac pacemakers and...
China, Beijing Fu Wai Hospital in Medical Professor Zhang Shu recently held in Hangzhou, China electrophysiology and cardiac pacing on the Eighth Conference of sudden cardiac death in China published in the latest developments and treatment sounded to the public Alarm: China has more than 50 million people each year die of sudden cardiac death, that every day there are at least 1480 people died in China. Prevention and treatment of sudden cardiac death in an effective way is to install a pacemaker, however, sudden cardiac death because people do not understand, there is concern on the installation of implantable devices, so my pacemaker very limited number of actual installation. Experts believe...
It is understandable that the pharmaceutical industry is rigorously regulated as the products have the potential to cause harm. FDA compliance is something which will be increasingly difficult to achieve because the watchdog are becoming noticeably more stringent - which is leading most to seek out the expertise of pharmaceutical consultancy firms. FDA compliance is imperative in all walks of pharmaceutical manufacturing and, in order to achieve it, the vast majority will aim to utilise the services and expert knowledge base of pharmaceutical consultants - who invariably offer years of experience in the field of compliance and FDA auditing. With so many medical devices and supplements hitting the...