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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 According to statistics, since 2016, nearly 300 products have been voluntarily withdrawn during the registration process.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

The State Administration held a press briefing on the Measures for the Supervision and Administration of Online Sales of Medical Devices.

On January 10, the State Administration for Market Regulation held a press briefing. A relevant official from the Medical Device Supervision Department of the Administration provided an interpretation and analysis of the key provisions of the newly promulgated Measures for the Supervision and Administration of Online Sales of Medical Devices (Order No. 38 of the Administration, hereinafter referred to as the “Measures”), as well as the regulatory landscape governing online medical device operations.

2018

01-11

Countries along the Belt and Road Initiative represent another major market for medical devices.

The Belt and Road Initiative underscores China’s new, all‑round approach to opening up its economy, while also sounding the call for a globally integrated allocation of resources. Chinese medical device companies have responded enthusiastically, eager to seize the opportunity. However, given the industry’s unique characteristics, enterprises face significant challenges along the path of the Health Silk Road, leaving them uncertain and struggling to move forward. So where exactly lie these pain points?

2018

01-29

Introduction to Jiangxi Hongda Pharmaceutical and Medical Device Technology Co., Ltd.

Jiangxi Hongda Medical Device Logistics Technology Co., Ltd. is a high-tech, information-driven enterprise that integrates medical device storage, transportation, and sales, with a focus on an all‑in‑one third‑party logistics platform for medical devices.

2018

03-01

Jiangxi Hongda Pharmaceutical and Medical Equipment Technology Co., Ltd. – WMS System

Jiangxi Hongda Pharmaceutical and Medical Equipment Technology Co., Ltd. – WMS System

2018

04-09

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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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