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2018-12-28

Biomedicine emerging as zone's pillar industry

After five years of development at the China-Singapore Suzhou Industrial Park, Innomed Medical Device plans to bring one of its guide wire products - widely used in cardiovascular operations - to major Chinese hospitals in the first quarter of next year. Innomed expects to mass produce the guide

2018-12-21

Chipmaker upbeat on tech talent

China's leading position in cutting-edge technology, like autonomous driving and 5G communications, will help groom the next generation of researchers, according to veteran industry experts at a major semiconductor company.

2018-12-17

3D Printing of Medical Devices

3D printing is a type of additive manufacturing. There are several types of additive manufacturing, but the terms 3D printing and additive manufacturing are often used interchangeably. Here we will refer to both as 3D printing for simplicity.

2018-12-17

Rühl Puromer opens first Chinese facility in Taicang

Rühl Puromer GmbH, a Germany-based supplier of polyurethane (PU) systems, announced the opening of its first Chinese facility in Taicang, Jiangsu province, on Dec 11.

2018-12-17

Doctors get a virtual helping hand

Smart medical solutions are emerging all over China in light of the national initiative to enhance health services using internet technologies.

2018-12-13

CHINA – Overview of medical device industry and healthcare statistics

Below you will find basic demographic and healthcare market data on China, plus specific information about the medical device and healthcare industries.

2018-12-12

This machine-learning system could help treat sepsis sooner

Massachusetts Institute of Technology researchers have developed a machine-learning system that could help clinicians decide when to treat patients for sepsis in the emergency room.

2018-12-11

The Digital Revolution in Medtech: Opportunities in Asia

Digital technology is revolutionizing the healthcare sector. The global digital health market was valued at approximately $122.66 billion in 2017. Investment in digital health startups reached $11.78 billion globally in 2017 alone, with 852 deals in total. Healthcare companies around the world are n

2018-12-09

The Rise Of Use Of Medical Devices Force FDA To Change The Rules

A disruptive market of $410 billion until 2023, changes dramatically with the entrance of small and medium size players, many of them rising up from the startup community. Software plays a big part in this shift as a differentiator in medical devices as well as the manufacturing of portable devices

2018-12-01

China NMPA Medical Device Regulations

Shown below are some important regulatory documents impacting medical device companies. Unfortunately, the NMPA only makes these available in Chinese.

2018-11-29

Chinese medical device manufacturers display core technologies in U.S.

CHICAGO, Nov. 26 (Xinhua) -- About 50 Chinese medical device manufacturers displayed their core technologies and latest achievements at a high-level meeting in the radiology industry that kicked off Sunday. The annual meeting of the Radiological Society of North America, an international society of

2018-11-20

WuXi AppTec launches medical device testing center in Suzhou

WuXi AppTec, a leading global pharmaceutical, biopharmaceutical and medical device company, has announced the launch of its Laboratory Testing Division's new medical device testing center in the city of Suzhou in China.

2018-08-12

China CFDA (now NMPA) Medical Device and Pharmaceutical Regulations

The China Food and Drug Administration (CFDA) (now NMPA) is the administrative body responsible for the regulation of medical devices and pharmaceuticals on the Chinese mainland. The CFDA is separated into various departments that are individually responsible for the registration, tracking, and mon

2018-08-09

Major Medical Device Changes In China Introduced by the 2018 Draft Amendment to the “Regulations on the Supervision and Administration of Medical Device”*

Following the issuance of the “Opinions on Deepening the Reform of Examination and Approval System and Encouraging Innovation in the Industries of Pharmaceuticals and Medical Devices” by the Central Office of the Communist Party of China and the Office of the State Council on October 1, 2017, the fo

2018-07-09

New AI wave coming for medical field

A large number of applications to get market approval for medical devices that employ deep learning, a subset of artificial intelligence, are expected to be filed next year, but full commercialization of the products is not necessarily within easy reach, China’s top medical device regulator said at

2018-03-21

AI could alleviate China’s doctor shortage

China is embarking on a big initiative to add AI to health care with tools like this one. In some ways the trend mirrors what is happening in the US and Europe. In China, however, restrictions on the use of data and new technologies are looser, and the need for automation is more pronounced. There a

2018-02-22

What to expect from the medical devices market in China

The Chinese government desires explosive growth in biomedical and high-end medical device manufacturing under the “Made in China 2025” plan. The plan identifies the goal of raising the domestic content of core components and materials to 40% by 2020 and 70% by 2025. The medical device industry is

2017-10-20

The 11 most innovative medical devices of 2017

The nominees for the best medical technology of 2017 were recently announced for the 11th Annual Prix Galien USA Awards.

2017-07-25

China - Medical Devices

This is a best prospect industry sector for this country. Includes a market overview and trade data.

2016-12-13

Be Very Careful in China’s Medical Device Market

Returning from a recent trip to China, I cannot overstate Chinese medtech companies’ desire to overtake the Western medical device business. Ten years ago, China made Class I and II commodity devices for export to the West. Many Western hospitals, clinics and nursing homes have become reliant on buy

2015-07-21

China's medical device adverse events rise 18.6%

BEIJING - China reported 41,018 medical device adverse events (MDAE) in 2014, up 18.6 percent from the previous year, according to China Food and Drug Administration (CFDA) Monday.

2015-01-13

Medical Device and IVD Registration in China

In China, Medical Devices (MDD) and In Vitro Diagnostic (IVD) reagents are regulated by following laws: The Regulations for the Supervision and Administration of Medical Devices (Decree No.650 2014)-main regulation Administrative Measures for Medical Device Registration(CFDA Order No. 4 2014) Adm

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DeviceDee Regulatory Affairs Department provides customized regulatory services for medical devices, based on domestic (CFDA) and international ( including CE、510k、CMDCAS、TGA、Thailand、Malaysia、 South Korea、IMMETRO etc.) regulatory. Our regulatory experts have years of experience with related authorities and are very familiar with regulatory requirements, they can provide you with feasible strategies and facilitate your communication with various regulatory agencies, both on technical and regulatory issues.We provide our clients with valuable advice and guidance, aiming to help reduce costs, save time, and improve the chances of successful registration of promising medical devices.

Our clinical trial operating team is comprised of domestic and overseas clinical experts, biostatistical scientists, and clinical research associates. By managing projects professionally and maintaining a good relationship with investigators, we always accomplish our projects as scheduled, hence help accelerate product launching and obtain high quality data.

GMP consulting is an important service we provide. Our services is to setup, improve and audit the GMP for medical device manufacturers. The aim is to help them achieve the standard which fulfills the authorities’ requirements. We provide our GMP consulting services based on different standard according to client’s requirements, such as CFDA GMP, ISO13485:2016, 21CFR820 or MDSAP.

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