NORTH ANDOVER, Mass. – July 27, 2018 – China Med Device, LLC (CMD), a leader in helping medical technology companies enter the Chinese marketplace, received the contract to guide China Mobile’s Regulatory approval as well as QMS in China for its remote digital diagnostic internet system. CMD, a proven leader in providing regulatory and commercial services, has a team of seasoned bilingual and bicultural professionals to navigate the rapidly changing landscape of the National Medical Product Administration (NMPA), formerly China Food & Drug Administration (CFDA). CMD competed with 3 companies in the government project and won the final contract after three rounds of an intensive bidding process.
China internet has accelerated the adoption of mobile and digital wearable devices. There are over 800 million mobile phone users in China, and the China mobile health market reached $125.3 billion in 2017, according to Statista. The well-developed digital environment and the aging population makes China very attractive to many manufacturers in digital wearable devices that utilize the smartphones for digital data transmission, storage, and diagnostics with AI.
CMD not only provides the entire product registration approval with NMPA (formerly CFDA) as medical devices but also will help establish the quality management system in its manufacturing facility. Since NMPA has traditionally mandated registration holders must have their own manufacturing facilities to obtain NMPA certificates, CMD’s team of regulatory managers also have the extensive China QMS/GMP experience to help clients obtain GMP approval from NMPA. The recent separation of registration holder from the manufacturing entity has only been implemented in limited regions such as Shanghai, Tianjin, and Guangdong.
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For a market analysis for remote diagnostics & wearable device in China, please email info@ChinaMedDevice.com.
The research report conducted by Transparency Market Research indicates that the wearable devices market, or the remote patient monitoring devices market, is anticipated to reach US$47.7 billion by the end of 2020. This represents a cumulative annual growth rate of 14.2%. The explosive growth is driven by 4 key factors:
1. The requirement of diagnosis and treatment of chronic diseases such as cardiac arrhythmias, diabetes, arthritis, and osteoporosis
2. Increasing technological advancements and innovations
3. Increasing per-capita income in developing countries
4. Ease-of-use and interpretation of medical devices
Currently leading western companies in the field are Biotricity Inc., Abbott Laboratories, FitBit, Apple, Alphabet, IBM, Samsung, Philips Electronics, Lifesense, Fitbit, and Garmin. China Mobile, with revenue of $108.5 billion in 2017, can certainly become a dominant player. It is the largest mobile telecommunications corporation by market capitalization, and also the world’s largest mobile phone operator by total number of subscribers, with over 902 million subscribers as of June 2018.
The NMPA (formerly CFDA) approval process has become more complex since the introduction of Decree 650 by the China State Council in 2014, and the 650 Amendment this June. Sweeping changes added several hundred new requirements, updates, and guidelines. Navigating this process, especially for start-ups or medium-sized MedTech companies, requires the services of an experienced partner who is familiar with the intricacies of the Chinese market, understands the local culture and has a wealth of hands-on experience.
“MedTech companies need to be more strategic in how they enter the market,” says CMD’s Founder and CEO Grace Fu Palma. “Selecting the right type of registration and type testing and understanding the clinical requirements as well as the downstream impacts on reimbursements, and public tendering process, provide a pathway to ultimate success. The approach we take at China Med Device integrates regulatory, technical, clinical and other factors to give companies the most cost-effective and timely entry into the Chinese medical device market.”
In 2018, NMPA (formerly CFDA) has witnessed another major overhaul that goes well beyond premarket submission and affects a variety of business areas, including registration, type testing, clinical requirements, 2 invoicing systems, DRG and reimbursement reform, and heavy focus on QMS. CMD’s 10+ years of experience in NMPA regulatory services, coupled with a seasoned bilingual and bicultural staff, and broad market knowledge offers clients a complete turn-key solution.
About China Med Device, LLC
China Med Device, LLC (https://ChinaMedDevice.com) provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, RA, clinical evaluation, CRO, QA and post market compliance. We are experienced in handling innovation approvals and priority reviews. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have offices in Beijing, Suzhou and Boston. Our management team has 100+ years of combined experience in medical device and IVD and has been involved with 1,000+ CFDA certificates and 250+ companies’ success.