Entering China’s Medical Device Market: Growth, Regulations & Strategic Insights

The webinar was successfully concluded on

May 7, 2025

What is it all about?

In a nutshell, during the webinar, our presenter – Summer Xia discussed the following topics:

Market Overview: China's Medical Device Industry
Market Entry Strategies
Risks, Challenges & How to Mitigate Them

As a continuous practice, Freyr organizes more webinar sessions related to Regulatory aspects in Life Sciences. We presume you would like to be a part of all those sessions. If yes, let us have an opportunity to inform you about our next session.

Yatharth, a dynamic business development leader with 4+ years of experience across Medical Devices, Pharmaceuticals, and Consumer Healthcare sectors, currently leads High growth initiatives at Freyr Solutions. He holds an MBA and brings deep expertise in regulatory consulting, client engagement, and market expansion.
Yatharth has successfully spearheaded high-impact projects for global clients, delivering solutions across product registration, market intelligence, and regulatory compliance. Known for his Account Ownership approach, he builds lasting partnerships, driving both client success and revenue growth.

With over 20 years of experience, including 15 years in medical device regulatory affairs, Summer has excelled in navigating both pre-market and post-market requirements. Her expertise has been instrumental in guiding numerous foreign and local manufacturing companies entering the Chinese market. Summer’s leadership has been demonstrated through her roles heading multinational Quality Assurance and Regulatory Affairs teams. She holds an MBA and is a certified Lead Auditor by BSI, enabling her to proficiently manage complex compliance landscapes.

Aspect	USA	EU	Australia	China	UAE
Regulatory Authority	FDA	EFSA & Member State Authorities	FSANZ	SAMR & NHC	ESMA & MOHAP
Major Regulation Governing Compliance	Federal Food, Drug, and Cosmetic Act (FFDCA); 21 CFR Part 110 (Current Good Manufacturing Practices)	Regulation (EC) No 178/2002 (General Food Law); Regulation (EU) No 1169/2011 on Food Information to Consumers	Food Standards Code (Australia New Zealand Food Standards Code)	Food Safety Law of the People's Republic of China (Revised 2015); GB Standards for Food Safety	UAE.S GSO 9:2017 (GCC General Requirements for Prepackaged Food)
Pre-market Approval Required?	No pre-market approval except for novel ingredients, color additives, or specific claims	No pre-market approval for general foods, but novel foods or health claims require EFSA approval.	No pre-market approval unless it's a novel food or makes health claims	Pre-market registration is required for novel foods, health foods, or products with new ingredients	Pre-market approval is required for certain foods, health products, and products with new ingredients
Processed Food Labeling Compliance /Labeling Requirements	Mandatory labeling as per FDA guidelines (Nutrition Facts, Ingredient Declaration, Allergens)	Must comply with EU Food Information Regulation (1169/2011); includes allergens, nutrition, and origin labeling.	Must follow FSANZ Food Standards Code for labeling; nutrition panels, allergens, and ingredient lists required	Must follow GB 7718-2011 (National Food Safety Standards) for labeling; mandatory nutrition facts, allergens, and shelf-life	Must follow GSO 9:2017 for pre-packaged food labeling; Arabic labeling, allergens, and nutrition facts required
Timeline for Registration	No fixed timeline: products can enter the market once compliant	No formal registration unless novel food; EFSA approval for health claims takes 12-18 months	No formal registration unless it's a novel food or makes health claims	Typically, 12-24 months for novel foods, shorter for regular processed foods	Approval may take 6-12 months for certain products. Regular processed foods can enter the market once label approval is obtained

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Medical Devices Regulatory Services

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Entering China’s Medical Device Market: Growth, Regulations & Strategic Insights

Entering China’s Medical Device Market: Growth, Regulations & Strategic Insights

What is it all about?

Host

Yatharth Sharma

Presenter

Summer Xia

How can we help you?

Please let us know your requirements, and we will contact you.