Press release
Find the details of Revised Chinese Special Examination and Approval Procedures for Innovative Medical Devices
Facing a gigantic population and rapid population aging, 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 aging 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.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.
How to grasp the opportunity to speed up your innovative medical device product approval? The overseas and multinational medical device manufacturers must have a comprehensive knowledge of the Chinese special examination and approval procedures for innovative medical devices.The Chinese regulatory approach is unique.
“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.
The organizations of this guidebook are arranged as follows. 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.
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.
Reasons To Buy
The Chinese “National Medical Products Administration (NMPA)” issued the latest “Special Examination and Approval Procedures for Innovative Medical Devices” on November 2, 2018, and implemented on December 1, 2018. 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. How to grasp the opportunity to speed up your innovative medical device product approval? The overseas and multinational medical device manufacturers must have a comprehensive knowledge of the Chinese special examination and approval procedures for innovative medical devices. The Chinese regulatory approach is unique.
“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.
About Us:
Our aim is to collate unparalleled Market insights and notify our customers as and when it happens.
Valuates is curating premium Market Research Reports from the leading publishers around the globe. We will help you map your information needs to our report repository of Market research reports and guide you through your purchasing decision. We are based out of silicon valley of India (Bengaluru) and provide 24/7 online and offline support to all our customers and just a phone call away.
Inquire for Purchase:https://reports.valuates.com/request/inquiry/ACCE-Book-33/Latest_Guidebook_for_Chinese_Special_Examination_and_Approval_Procedures_for_Innovative_Medical_Devices
Inquire for Sample:https://reports.valuates.com/request/sample/ACCE-Book-33/Latest%20Guidebook%20for%20Chinese%20Special%20Examination%20and%20Approval%20Procedures%20for%20Innovative%20Medical%20Devices
Contact Us:
Phone:
U.S. (TOLL FREE) : +1 (425) 388-2538
India: +91 8040957137
Email Id:
Please reach us at sales@valuates.com
Address:
Valuates,
4th Floor,
Balaraj's Arcade,
Whitefield Main road,
Bangalore 560066,
To know more visit us on:
Website: reports.valuates.com
Linkedin: www.linkedin.com/company/valuatesreports
Facebook: www.facebook.com/valuatesreports
Twitter: twitter.com/valuatesreports
Instagram: www.instagram.com/reportsvaluates
Youtube: www.youtube.com/channel/UCH4wNXynaTZbiD5m92WQI4A
This release was published on openPR.
Permanent link to this press release:
Copy
Please set a link in the press area of your homepage to this press release on openPR. openPR disclaims liability for any content contained in this release.
You can edit or delete your press release Find the details of Revised Chinese Special Examination and Approval Procedures for Innovative Medical Devices here
News-ID: 1697658 • Views: …
More Releases from Valuates Reports
2-Oxazolidinone Market Revenue, Insights, Overview, Outlook, Analysis | Valuates …
2-Oxazolidinone Market Size
The global market for 2-Oxazolidinone was valued at US$ 732 million in the year 2024 and is projected to reach a revised size of US$ 916 million by 2031, growing at a CAGR of 3.3% during the forecast period.
Get Free Sample: https://reports.valuates.com/request/sample/QYRE-Auto-1I12558/Global_2_Oxazolidinone_Market?utm_source=Openpr&utm_medium=Referral
This report aims to provide a comprehensive presentation of the global market for 2-Oxazolidinone, with both quantitative and qualitative analysis, to help readers develop business/growth strategies, assess…
Strontium-88 Market Revenue, Insights, Overview, Outlook, Analysis | Valuates Re …
Strontium-88 Market Size
The global market for Strontium-88 was valued at US$ 89 million in the year 2024 and is projected to reach a revised size of US$ 126 million by 2031, growing at a CAGR of 5.2% during the forecast period.
Download Free Sample: https://reports.valuates.com/request/sample/QYRE-Auto-34T9158/Global_Strontium_Market?utm_source=Openpr&utm_medium=Referral
This report aims to provide a comprehensive presentation of the global market for Strontium-88, with both quantitative and qualitative analysis, to help readers develop business/growth strategies, assess…
Cobalt Sulfate Heptahydrate Market Revenue, Insights, Overview, Outlook, Analysi …
Cobalt Sulfate Heptahydrate Market Size
The global market for Cobalt Sulfate Heptahydrate was valued at US$ 449 million in the year 2024 and is projected to reach a revised size of US$ 729 million by 2031, growing at a CAGR of 6.9% during the forecast period.
Get Free Sample: https://reports.valuates.com/request/sample/QYRE-Auto-19T19438/Global_Cobalt_Sulfate_Heptahydrate_Market?utm_source=Openpr&utm_medium=Referral
The 2025 U.S. tariff policies introduce profound uncertainty into the global economic landscape. This report critically examines the implications of recent tariff adjustments…
Ultrasonic Fabric Cutting and Sealing Machine Market Revenue, Insights, Overview …
Ultrasonic Fabric Cutting and Sealing Machine Market Size
The global market for Ultrasonic Fabric Cutting and Sealing Machine was valued at US$ 1200 million in the year 2024 and is projected to reach a revised size of US$ 2091 million by 2031, growing at a CAGR of 8.2% during the forecast period.
Get Free Sample: https://reports.valuates.com/request/sample/QYRE-Auto-12M18905/Global_Ultrasonic_Fabric_Cutting_and_Sealing_Machine_Market?utm_source=Openpr&utm_medium=Referral
This report aims to provide a comprehensive presentation of the global market for Ultrasonic Fabric Cutting and…
More Releases for Chinese
Gao Yuan at UN Chinese Language Day: Bridging Cultures Through Traditional Chine …
On April 20, 2025, CCTV host Gao Yuan participated in the UN Chinese Language Day celebrations at the United Nations Headquarters in New York, showcasing the profound heritage and innovative vitality of traditional Chinese arts to a global audience.
Image: https://www.globalnewslines.com/uploads/2025/04/556563a6bf5cb3de8982c8ef94cb6380.jpg
During the thematic forum "Civilizational Dialogue and Artistic Symbiosis," Gao Yuan moderated a cultural salon titled "Digital Technology Empowers Traditional Arts." She highlighted China's recent efforts to reinterpret calligraphy and ink…
The TV program "Chinese Practice with Chinese Wisdom" Officially Airs: The Endur …
Chinese Practice with Chinese Wisdom is a 10-episode TV program produced by Jiangsu Broadcasting Corporation, one of the most influential media groups in China. It gives a vivid presentation of traditional Chinese cultural elements such as poetry, calligraphy, seal-cutting, traditional Chinese operas, dance, and martial arts, aiming to enrich audiences with cultural enlightenment and aesthetic enjoyment. Through questions, disucssions, elaborations, feelings, and stories shared by guests from around the world,…
Chinese Fenjiu Shines at SCWC Conference, Bridging Chinese Liquor and Western Cu …
Fenjiu Debuts at the International Stage, Blending Tradition, Innovation, and Cultural Fusion, while Captivating Global Food and Beverage Experts.
Barcelona, Spain - November 22, 2024 - Fenjiu, a premier Chinese liquor brand, made a landmark appearance at the Science and Cooking World Congress (SCWC) in Barcelona, Spain. Renowned for its light-fragrance style and rich cultural heritage, Fenjiu captivated global food and beverage professionals as it showcased its unique blend of tradition,…
Online Chinese Language School
Taiwan Chinese Education Center is an online Chinese language school.
You can learn Chinese one-on-one from the best Chinese teachers in Taiwan.
We opened our school in Japan in 2010 and have over 12 years of rich experience in online Mandarin teaching.
In November 2022, we started Mandarin education service for people in Europe, America, and other countries.
Chinese is the world's No. 1 native language, spoken by about 15% of the world's population.
About…
Chinese Investors Look Abroad
Beijing, China July 30, 2012 – An Outbound Investment Seminar hosted by Chance & Bridge Partners drew a large audience of investors, Chinese SMEs, and international partner law firms.
Many Chinese investors and companies are looking to diversify their holdings and enter new markets. This has led to an increase in cross-border investment, banking, consulting, and legal services for the Chinese clients. Many of these areas were addressed during the…
Introducing A New Chinese Reader to Enable Chinese Language Students to Master C …
Capturing Chinese presents a new advanced Chinese reader helping students master the literature of China's best authors. Allowing students to put down their dictionaries and instead curl up with a book of Chinese literature, Capturing Chinese is a must have for intermediate and advanced Chinese language students.
The new book, titled Capturing Chinese Stories: Prose and Poems by Revolutionary Authors, features five of the most influential authors in recent Chinese history…