Understand Chinese Overseas Innovative Medical Devices Regulations And Speed Up Entering Into China Market

USA - English

• India - English

BANGALORE, India, April 9, 2019 /PRNewswire/ -- Chinese special examination and approval procedures for innovative medical devices established a fast-track approval path and an interactive mechanism between the Chinese drug regulatory authorities and the applicant for innovative medical devices, which reduces risk from the review uncertainty and approval delays that avoid to exhaust applicant's time and energy.

This fast-track approval path and an interactive mechanism between the Chinese drug regulatory authorities and the applicant for innovative medical devices offer a huge business opportunity for the foreign medical device manufacturers to achieve a successful entry into Chinese healthcare market and smoothly operate their business in China

In order to speed up you should know the list of innovative medical devices that are applicable to Chinese special examination and approval procedures, Who are the Chinese regulatory authorities for approval?,  How many application dossiers for special examination, detailed practical guidance to smoothly navigate complex regulatory requirements, priority processing and acquire the needed qualifications significant suggestions for imported devices & full set of overseas bilingual forms with feedback from Chinese regulatory authority.

Facing a gigantic population and rapid population ageing, China's regulatory framework for medical devices is undergoing radical changes. In order to promote the implementation of a strategy of healthy China, transform the treating diseases as focal points into the people's health as centre, prevent and control the major diseases, actively respond to the ageing of the population and accelerate the development of aged healthcare service to give the populace with a full range and full-cycle health and medical services for lifetime,

The Chinese "National Medical Products Administration (NMPA)" issued the latest modified version of "Special Examination and Approval Procedures for Innovative Medical Devices" on November 2, 2018, and implemented on December 1, 2018. Its aim is to encourage research and innovation of medical devices, promote the popularization and application of new technologies for medical devices to finally meet the growing medical care needs.


The organizations of this guidebook are arranged as follows.

• Chapter 1: Executive Summary
• Chapter 2 introduces what innovative medical devices are applicable to Chinese special examination and approval procedures.
• Chapter 3 introduces who are the Chinese regulatory authorities for special examination and approval of overseas innovative medical devices.
• Chapter 4 elaborates the special regulations for overseas applicant.
• Chapter 5 introduces how many application dossiers for an oversea innovative medical device should be prepared.
• Chapter 6 provides the practical guidance for application of special examination and approval procedures of overseas innovative medical devices.
• Chapter 7 elaborates the benefits from special examination and approval procedures of innovative medical devices: priority processing and interactive mechanism.
• Chapter 8 conclusions give significant suggestions for overseas and multinational medical device manufacturers to acquire the qualifications of special examination and approval procedures for overseas innovative medical devices.
• Chapter 9 appendices provide a full set of the English and Chinese bilingual forms relating to the overseas applicant applying for special examination and approval procedures of overseas imported innovative medical device and information communication and exchange of overseas imported innovative medical device with the Chinese drug regulatory authorities, and the feedback letter from the Chinese drug regulatory authorities.

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The audiences of this guidebook are overseas medical device manufacturers wishing to enter into the Chinese medical device market, and multinational medical device companies have penetrated into the Chinese medical device market, and their senior executive officers engaging in regulatory affairs expecting to understand how to apply for registration of their medical device products in China and how to comply with the latest Chinese regulations for medical device registration.

After having skimmed through this guidebook, audiences can clearly acquire not only a comprehensive knowledge of the latest Chinese special examination and approval of overseas innovative medical devices but also the practical operation how to comply with the latest Chinese special examination and approval of overseas innovative medical devices. Access China Management Consulting Ltd hopes this guidebook, based on full and accurate regulations, can guide overseas and multinational medical device manufacturers and producers to achieve a successful entry into the Chinese medical device market and smoothly operate their products in China.

"Latest Guidebook for Chinese Special Examination and Approval Procedures for Innovative Medical Devices (2019 Edition): speed up overseas innovative medical devices entry into Chinese market" provided a comprehensive knowledge of the latest Chinese special examination and approval procedures for innovative medical devices to guide your practical operation how to comply with the Chinese regulations. It is an essential resource for overseas and multinational medical device manufacturers to speed up overseas innovative medical devices entry into Chinese market, which provides not only a comprehensive knowledge of the latest Chinese special examination and approval procedures for innovative medical devices but also the practical operation how comply with the latest Chinese regulations to smoothly navigate complex regulatory requirements.

Key Highlights

• What overseas imported innovative medical devices are applicable to Chinese special examination and approval procedures?
• Who are the Chinese regulatory authorities for special examination and approval of overseas imported innovative medical devices? 
• The Chinese special regulations for overseas applicant.
• How many application dossiers for special examination and approval procedures of an oversea imported innovative medical device should be prepared?
• The detailed practical guidance for application of special examination and approval procedures of overseas imported innovative medical devices to smoothly navigate complex regulatory requirements.
• What are the benefits from Special Examination and Approval of Innovative Medical Devices: Priority Processing and Interactive Mechanism.
• The significant suggestions for overseas and multinational medical device manufacturers to acquire the qualifications of special examination and approval procedures for overseas imported innovative medical devices.
• A full set of the English and Chinese bilingual forms relating to the overseas applicant applying for special examination and approval procedures of overseas imported innovative medical device and information communication and exchange of overseas imported innovative medical device with the Chinese drug regulatory authorities, and the feedback letter from the Chinese drug regulatory authorities.

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