Topic:
Keep up with the Trend of Medical Devices Localization in China:
Background, Policy, Regulation, and Case Study
Schedule:
Country | US & Canada | Europe | China |
Schedule | Wed, November 2 7:00am-8:00am PDT, 10:00am – 11:00am EDT | Wed, November 2 4:00pm-5:00pm CET | Wed, November 2 10:00pm-11:00pm Beijing Time |
Description:
Since the release of “Made in China 2025” by the State Council of China in 2015, the localization of domestic medical devices is becoming a general trend. In recent years, the state has continuously introduced policies to encourage and support domestic substitution of medical devices.
In April 2022, the Anhui province issued the Circular on Regulation Government Procurement of Imported Products by Public Medical Institutions, which prohibits all public medical institutions from purchasing imported products without approval. Since 2021, Zhejiang, Guangdong, Sichuan, and Shanxi Provinces have successively released the latest “Imported Medical Device Procurement List” to tighten the product type and quantity of imported medical devices. From encouraging to prioritizing domestic production, and now purchasing domestic medical devices, these policies have provided a more favorable competitive environment for domestic products.
For a long time, imported medical devices have occupied a leading position in the Chinese market, especially for high-end products. However, in most low-end markets, price and patient affordability remain decisive. International companies still face price-based simple competition, especially under the preference and protection of domestic production. To better develop the economical market, some companies decided to switch to local production.
As a leading consulting company for China’s medical device market entry, BradyKnows Medical has helped many international companies to develop China’s localization strategies to ensure their regulatory compliance with the local authorities. In this webinar, the agenda includes:
Agenda:
- Introduction of China localization of medical devices
- Key policies supporting medical device localization in China
- Multiple solutions to achieve China localization
- NMPA registration of domestic medical devices
Registration Link:
https://us06web.zoom.us/webinar/register/WN_8EkP-_8pQTiC7-WaZ0yiMQ
Speakers:
Tracy Yu
General Manager & Senior Project Manager, BradyKnows Medical
Tracy Yu is a versatile regulatory and clinical research professional with nearly a decade of expertise. Her responsibilities include the development of regulatory and clinical strategies and management of pre-market approval projects from planning to completion, covering type testing, clinical trials/CER, consultation meeting with China NMPA reviewer, and post-market inspection and China localization projects.