Registration of in vitro diagnostic products

Medical device market is ranked second largest in the world. Population growth is growing at about 20 percent since 2009. It is expected to maintain this growth over the next few years. the predicted growth rate of the global market. By 2020, China will have 400 million people who are 60 years-old or older, and 100 million older than 80. By 2050, a third of the 1.4 billion Chinese will be at least 60.

Pharmaceutical Materials Association's Medical Device Branch, the market size reach RMB300 (over $ 48) billion by 2015. The driving factors include fast growing growth, the world's largest population, a growing population, and population growth. The government has invested heavily in the healthcare infrastructure and the provision of basic health insurance for all of its citizens. Currently, there are two types of foreign-sourced products, such as GE, Philips, and Siemens.

According to Shanghai FDA, by the end of 2013 there were a total of 17,800 domestic medical device manufacturers and 180,000 distributing companies. China's total sales volume was RMB 215 ($ 34.68) billion in 2013, representing a growth of 22% since the close of fiscal year 2012. The United States ranks # 1 in the medical market, followed by Germany and Japan. These three countries represent the majority share of China's imports. According to the China Chamber of Commerce for Import and Export of Medicines and Health Products (CCCMHPIE), China's import and export value of medical equipment reached $ 34.31 billion in 2013, an increase of 14% over 2012. 11 China has over 16,000 hospitals, 85% of which are publicly-owned. The Chinese hospitals consider US

At the same time, they are consolidating, upgrading quality, and beginning to compete in medium-sized technology niches. With the government policy to align and promote medical device innovations, some domestic manufacturers such as Shenzhen Mindray are growing stronger and are already competing with foreign suppliers.

Given the status of the Chinese medical device market, the company is interested in expanding the Chinese market. On the other hand, the new healthcare reform, qui started in 2009, is at the course of advancing the reform on public hospitals. An accumulated investment of over RMB 2.242 trillion ($ 359 trillion) has-been Invested by the government during the last five years to Improve the healthcare infrastructure. The reform will definitely impact future medical device sales opportunities in China. Companies interested in entering the marketplace. Recently, China's State Council announced changes in the Regulation for Supervision and Administration of Medical Devices (Order 650), slated for implementation on June 1, 2014. Order 650 is the revision of the old regulation Order 276 qui Was Implemented in 2000. As the regulator of medical devices, China Food and Drug Administration (CFDA) is expected to issue a number of technical documents on June 1st for this new regulation. Compared with the old regulation, noticeable changes include the validity of the registration certificate to five years; adopting a notification system to replace the registration system for all Class I products; Chinese language on the product manual, labels, and packaging labels; Required clinical trials inside China for the Class II and Class III medical devices that are not on the CFDA's exemption catalog. Additional issues and challenges that the US expects will face include pricing, and bar code systems that are delaying entry into the Chinese medical device market. Sub-Sector Best Prospects The best-selling prospects in the medical device sector include: • In vitro diagnostic equipment and reagents: Clinical and diagnostic analysis equipment, diagnostic reagents, medical test and basic equipment instruments, and point of care testing (POCT). • Implantable and speech materials and artificial organs: Interventional materials, implantable artificial organs, artificial organs touch, stent, implantable materials, and artificial organ Assisting equipment. medical test and basic equipment instruments, and point of care testing (POCT). Implantable and interventional materials and artificial organs: Interventional materials, implantable artificial organs, artificial contact organs, stent, implantable materials, and artificial organ assisting equipment. medical test and basic equipment instruments, and point of care testing (POCT). Implantable and interventional materials and artificial organs: Interventional materials, implantable artificial organs, artificial contact organs, stent, implantable materials, and artificial organ assisting equipment.

• Therapeutic products: Tri-dimensional ultrasound-focused therapeutic systems, body rotational Gamma knife, simulator, linear accelerator, laser diagnosis and surgical equipment, nuclide treatment equipment, physical and rehabilitation equipment. 12 • Medical diagnostic and imaging equipment: Black & white and supersonic diagnostic units, sleeping monitor, digital X-ray system, MRI, CT, DR, and ultrasound equipment. • Surgical and emergency appliances: Anesthesia ventilation systems and components: high frequency surgical equipment, high frequency and voltage generators. • Healthcare Information Technology related equipment and products: Medical software, computer aided diagnostic equipment, and hospital information systems (HIS, CIS, and HLT). • Medical equipment parts and accessories.

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Created on Sep 27th 2018 08:57. Viewed 377 times.

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