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Medical Devices: Domestic Manufacturers Oust Imports—These Four Key Sectors Show Promise!

Medical devices: Rapid growth is expected, with substantial room for import substitution. From an industry perspective, China’s medical device market has surpassed RMB 300 billion, making it the second-largest globally. However, medical device spending accounts for only 17% of the overall pharmaceutical market—just 40% of the level in developed countries. With population aging and rising health‑insurance reimbursement levels, the market is projected to expand by at least another 5 percentage points over the next five years, translating into additional market growth exceeding RMB 300 billion.

2017

10-27

Jointly Exploring the Path of Reform and Innovation in the Medical Device Industry

If the issuance of the “Opinions on Reforming the Review and Approval System for Drugs and Medical Devices” marked the beginning of reforms in this area, then the recently released “Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation in Drugs and Medical Devices,” issued by the Two Offices, will further advance structural adjustments and technological innovation within the pharmaceutical and medical device industries.

2017

11-18

Medical device and pharmaceutical reform has expanded from review and approval to a transformation of the regulatory system.

Recently, the General Office of the CPC Central Committee and the General Office of the State Council jointly issued the “Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation in Pharmaceuticals and Medical Devices” (hereinafter referred to as the “Opinions”). Following the August 2015 “Opinions of the State Council on Reforming the Review and Approval System for Pharmaceuticals and Medical Devices,” this document represents another landmark policy paper aimed at further advancing reforms of the review and approval system for pharmaceuticals and medical devices. It can be seen as a comprehensive summary and deepening of the two-year experience gained in reforming this system, as well as a concentrated embodiment of the strategic decisions and arrangements made by the CPC Central Committee and the State Council regarding the regulation of food and drugs.

2017

11-19

Xi Jinping: Implement the National Big Data Strategy and Accelerate the Development of Digital China.

On the afternoon of December 8, the Political Bureau of the CPC Central Committee held its second collective study session on implementing the National Big Data Strategy. While presiding over the session, General Secretary Xi Jinping emphasized that big data is advancing at a rapid pace, and that we must assess the situation, plan carefully, make forward‑looking arrangements, and strive to take the initiative. He called for a deep understanding of the current state and trends of big data development and its impact on economic and social progress, an analysis of both the achievements and the challenges facing China’s big data sector, and vigorous efforts to implement the National Big Data Strategy—accelerating the improvement of digital infrastructure, promoting the integration and open sharing of data resources, ensuring data security, and speeding up the building of a Digital China to better serve the country’s economic and social development and enhance the well‑being of the people.

2017

12-09

Why is it so difficult to pass medical device registration inspections? Only by establishing a robust quality management system can you successfully clear the final hurdle before market launch.

With the introduction of the concept of full‑life‑cycle management for medical devices, China’s medical device regulatory framework has continued to become more standardized, and evidence‑based regulatory measures are being systematically implemented and refined. According to statistics, since 2016, nearly 300 products have been voluntarily withdrawn during the registration process. “The primary reasons are deficiencies or shortcomings in areas such as R&D compliance, risk management, clinical trial integrity, and manufacturing practices,” explained Jiang Haihong, Director of the Medical Device Regulation Program at Shanghai Health Medical College.

2017

12-15

2018: Eight Major Trends in the Medical Device Market

1. High-value consumables are bidding farewell to their high gross margins. Following the National Development and Reform Commission’s 2017 negotiations for three categories of high-value consumables, prices plummeted. And these three are by no means the only ones; additional national-level price‑negotiation rounds for more high-value consumables are expected in 2018, using price reductions to secure larger market volumes—something that may well be beneficial for companies, as survival remains the top priority at this stage.

2017

12-22

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30 Years of Cultivation and Development

The “Hongda” brand products manufactured by the Group encompass eight major categories of medical devices, including syringes, infusion (and blood) sets, puncture instruments, auxiliary diagnostic equipment, anesthesia supplies, catheters, comprehensive solutions for blood purification, and multimodal smart healthcare information management systems.

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