scholarly journals Marketing authorization of medical devices in China

2016 ◽  
Vol 22 (1) ◽  
Author(s):  
Weifan Zhang ◽  
Rebecca Liu ◽  
Chris Chatwin
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Marketing Authorization ◽  
Regulatory Environment ◽  
Doing Business ◽  
The Us ◽  
Research Gap ◽  
Business In China ◽  
China’S Economy

Medical device regulations across the globe have significant variations. The Chinese medical device market, like China’s economy, is developing rapidly. This article reviews the medical device regulations in China and illustrates the major changes that have been recently implemented according to the new medical device regulations that came into force on the 1st June, 2014. Most regulatory research has focused on the US and EU medical device regulations with little written about the Chinese medical device regulations. The purpose of this article is to bridge the research gap and to introduce the Chinese medical devices regulatory environment to investors or companies who are engaged in the medical device market or doing business in China

Regulating Medical Devices in the United States

2020 ◽  
Author(s):  
Patricia J. Zettler ◽  
Erika Lietzan
Keyword(s):  
United States ◽  
Medical Device ◽  
Medical Devices ◽  
Complete Information ◽  
The United States ◽  
Risk Level ◽  
Management Tools ◽  
Medical Technologies ◽  
The Us ◽  
Medical Device Regulation

This chapter assesses the regulation of medical devices in the United States. The goal of the US regulatory framework governing medical devices is the same as the goal of the framework governing medicines. US law aims to ensure that medical devices are safe and effective for their intended uses; that they become available for patients promptly; and that manufacturers provide truthful, non-misleading, and complete information about the products. US medical device law is different from US medicines law in many ways, however, perhaps most notably because most marketed devices do not require pre-market approval. The chapter explores how the US Food and Drug Administration (FDA) seeks to accomplish its mission with respect to medical devicecough its implementation of its medical device authorities. It starts by explaining what constitutes a medical device and how the FDA classifies medical devices by risk level. The chapter then discusses how medical devices reach the market, the FDA's risk management tools, and the rules and incentives for innovation and competition. It concludes by exploring case studies of innovative medical technologies that challenge the traditional US regulatory scheme to consider the future of medical device regulation.

The Crowd, the Cloud and Improving the Future of Medical Device Innovation

2014 ◽  
Vol 17 (1) ◽  
pp. 13-20
Author(s):  
Marco Huesch ◽  
Robert Szczerba
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Business Models ◽  
Regulatory Environment ◽  
New Approach ◽  
Current State ◽  
Development Processes ◽  
Reducing Costs ◽  
Innovation Practices ◽  
Start Ups

Abstract Barriers and delays to medical device innovation are often solely attributable to the regulatory environment instead of both the current state of innovation practices and product development processes in the industry. Increasing the pace of innovation while reducing costs requires the creation of a new approach that fits both established medical device corporations as well as entrepreneurial start-ups. In this commentary we advance the concept of innovation platforms to facilitate ideation in the medical device space. Such platforms could also allow the full health benefits from individual medical devices to be reaped, by overcoming interoperability concerns through simulation and credentialing. Given the dramatic benefits of medical device success, such non-traditional business models for development may be potential solutions for industry, users and regulators.

scholarly journals REGULATIONS OF REGISTRATION AND IMPORT OF MEDICAL DEVICE IN INDIA

2018 ◽  
Vol 6 (1) ◽  
pp. 8-12
Author(s):  
Vikaas Budhwaar ◽  
Yogesh Rohilla ◽  
Manjusha Choudhary ◽  
Prateek Kumar
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Marketing Authorization ◽  
Indian Agent ◽  
Registered Office ◽  
A Company ◽  
Do So

India is a huge market for medical devices and is increasing constantly for the last few years. The registration certificate and import license is mandatory for a manufacturer of India who wishes to import any medical device in India. If a company which wants to imports its medical devices in India does not have a registered office in India it needs Indian agent authorized by CDSCO, to do so. Duly filled form-10 is required to be submitted for import license, while form-44 duly filled is required to be submitted for marketing authorization of a new medical device or its re-registration. The review focuses on regulation concerned to the registration procedures import of a new medical device in India with latest amendments in the regulation concerned.

Trends in software as a medical device (Preprint)

2020 ◽  
Author(s):  
Aaron Ceross ◽  
Jeroen Bergmann
Keyword(s):  
Health Care ◽  
Data Analysis ◽  
High Risk ◽  
Adverse Events ◽  
Medical Device ◽  
Empirical Analysis ◽  
Medical Devices ◽  
Digital Revolution ◽  
The Us ◽  
Software Registration

UNSTRUCTURED Software-as-a-medical-device (SaMD) has gained popularity as a type of medical device. However, to date, empirical analysis of SaMD trends have been lacking. Using databases managed by the US medical device regulator (the Food and Drug Administration), we map the path SaMD takes towards classification and recorded adverse events. The findings show that while SaMD has been identified in literature as an area of development, the data analysis suggests that this growth has been modest. These devices are overwhelming classified as moderate to high risk and they take a very particular path to that classification. The digital revolution in health care is less pronounced when evidence is considered of SaMD. In general, the trend for software registration mimics that of medical devices.

Developments in Rules of state registration of medical devices

2019 ◽  
Vol 2019 (3) ◽  
pp. 24-27
Author(s):  
Анфиса Миронова ◽  
Anfisa Mironova
Keyword(s):  
Medical Device ◽  
Russian Federation ◽  
Medical Devices ◽  
Regulatory Environment ◽  
The Russian Federation ◽  
State Registration

This article dedicated to analysis of the key developments in the legal and regulatory environment in a circulation of medical devices in the Russian Federation in regard to procedure of state registration of medical devices, as well as amending documents of the registration dossiers of the medical device, which have to be taken into account by the applicant in the process of submission of documents to Roszdravnadzor.

scholarly journals In-depth review on ‘innovation and regulatory challenges of the drug delivering medical devices’

2018 ◽  
Vol 15 (1) ◽  
pp. 18-28
Author(s):  
Patel Drashti ◽  
Charmy S Kothari ◽  
Singh Shantanu ◽  
Shah Manan
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
High Growth ◽  
Growth Potential ◽  
Guidance Document ◽  
The European Union ◽  
Profit Margins ◽  
The Us ◽  
High Growth Potential ◽  
Regulatory Challenges

The medical device market is generally seen as an area with high growth potential and provides greater profit margins including significant positive benefits to the patients. As the medical device regulations and the guidance document are becoming stringent in the US, manufacturers of these types of products are now facing these conundrums along with a need for clarification on matters related to various drug and device provisions. The European Union is making major changes to the Medical Device Directive which is its regulatory scheme for devices. Some parts are focused on the medical devices. The new changes in the regulations represent an important step forward in the growing philosophy of medical devices in Europe. Along with the regulatory challenges, there are various challenges faced during the innovation of such products. There are many factors that affect innovation including the patent aspects. In general, the key thing is that small firm face lots of difficulty compared to larger firm in bringing medical device in market. Thus, the proposed manuscript focuses on understanding the regulatory issues in various countries for ease of innovation and marketing authorization of medical devices.

An Assessment of the EU Approach to Medical Device Regulation against the Backdrop of the US System

2010 ◽  
Vol 1 (2) ◽  
pp. 137-149
Author(s):  
Bernhard Lobmayr
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Medical Condition ◽  
Regulatory Systems ◽  
Information Time ◽  
The Us ◽  
European System ◽  
Government Involvement ◽  
The Eu ◽  
Medical Device Regulation

A medical device is intended to alleviate a medical condition or to substitute a body function. The use of medical devices entails risks, first and foremost for patients who usually lack the necessary information, time and ability for informed decisions. Based on this, societies choose to regulate these products. Government involvement in medical device regulation seems to be more pronounced and centralised in the US than it is in the EU, where the system involves privatised elements. A consultation, initiated by the European Commission in 2008, proposed at its centre the introduction of a European medical device agency. By this the European system would follow the US benchmark. This research discusses some fundamental questions pertaining to the risk concept in medical devices, namely how risks are currently being addressed in the two most important regulatory systems of the US and the EU, and how the European system might be adjusted in the future.

scholarly journals Brief Talking about the Development of Medical Device Industry in China

2019 ◽  
Vol 2 (4) ◽  
pp. 24
Author(s):  
Yiling Bao
Keyword(s):  
Health Care ◽  
Medical Device ◽  
Medical Devices ◽  
Living Standards ◽  
Policy Support ◽  
Continuous Development ◽  
Medical Device Industry ◽  
Aging Society ◽  
China’S Economy ◽  
Device Industry

With the continuous development of China's economy and the improvement of Chinese’ living standards, people's awareness of health care has gradually increased, so the demand for medical devices products is also strengthen. In addition, China is gradually entering an aging society and policy support for the medical device industry. China's medical device industry is developing rapidly.

scholarly journals REGULATIONS OF REGISTRATION AND IMPORT OF MEDICAL DEVICE IN INDIA

2018 ◽  
Vol 6 (1) ◽  
pp. 8-12
Author(s):  
Vikaas Budhwaar ◽  
Yogesh Rohilla ◽  
Manjusha Choudhary ◽  
Prateek Kumar
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Marketing Authorization ◽  
Indian Agent ◽  
Registered Office ◽  
A Company ◽  
Do So

India is a huge market for medical devices and is increasing constantly for the last few years. The registration certificate and import license is mandatory for a manufacturer of India who wishes to import any medical device in India. If a company which wants to imports its medical devices in India does not have a registered office in India it needs Indian agent authorized by CDSCO, to do so. Duly filled form-10 is required to be submitted for import license, while form-44 duly filled is required to be submitted for marketing authorization of a new medical device or its re-registration. The review focuses on regulation concerned to the registration procedures import of a new medical device in India with latest amendments in the regulation concerned.

scholarly journals Classification and evaluation of medical devices

2003 ◽  
Vol 3 (2) ◽  
pp. 42-45
Author(s):  
Edina Vranić
Keyword(s):  
Health Care ◽  
Medical Care ◽  
Medical Device ◽  
Medical Devices ◽  
Public Interest ◽  
Response Times ◽  
Regulatory Environment ◽  
The Public ◽  
High Standards ◽  
Small Manufacturers

Medical devices and medical disposables contribute significantly to the quality and effectiveness of the health care system. It is necessary to commit scientifically sound regulatory environment that will provide consumers with the best medical care. This includes continued services to small manufacturers, readily available guidance on FDA requirements, predictable and reasonable response times on applications for marketing, and equitable enforcement. But in the public interest, this commitment to the industry must be coupled with a reciprocal commitment: that medical device firms will meet high standards in the design, manufacture, and evaluation of their products. The protections afforded our consumer, and the benefits provided the medical device industry, cannot be underestimated.

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