Business Finland together with other Team Finland players, in collaboration with Cisema, is organizing a China Masterclass for Achieving Product Approvals of Medtech, Cosmetic and Health Food Products on Tuesday 18 April 2023 at 9:00 – 10:00 (EET) Finnish time / 14:00 – 16:00 (CST Beijing).
Cisema is a CRO (clinical research organization) and turnkey regulatory affairs solutions provider for the Mainland China and Hong Kong market. Its special focus is China product registration. In China, certain product groups require compulsory registration (e.g. NMPA, CCC, CEL, CML) before they can be imported, traded and used. Cisema is a one-stop service provider supporting companies register products for sale in China, conduct clinical trials and monitor post-registration compliance.
Participants will receive guidance on regulatory pathways for the key export areas of medtech, cosmetics (including cosmetic ingredients) and health food, so that you can better plan for and succeed in the China market.
- Representatives of Team Finland
- Hamish King (Cisema HK), CEO of Cisema
- Guo Ning (Cisema Beijing), General Manager of Beijing
- 14:00-14:05 Introduction and welcome speeches from Team Finland
- 14:05-14:35 Medtech
- 14:35-15:05 Health Food
- 15:05-15:35 Cosmetics & Cosmetic ingredients
- 15:35-15:45 General Overview of China Food Market Access by Team Finland
- 15:50-16:00 Q&A
Topics under each theme
- Regulatory framework for medtech and digital health products in China
- Local agent requirements (NMPA Legal Agent) and options for Finnish manufacturers
- Registration pathways for medtech products, including potential fast-track
- Risk classification in China and implications for timeline, documentation and costs
- Local in-China testing requirements for product approval applications
- Clinical evaluation reports for China – can you just use your CER from CE mark?
- Registration and filing processes with SAMR for functional health food and nutritional supplements, including cross border e-commerce options
- What happens if you’re health food or supplement is not on the specific accepted lists?
- “blue hat” status and what this means
- What health claims are permitted in China for health food and supplements?
- Timeline and costs
- Local representative agent requirements for applicants
Cosmetics & Cosmetic ingredients
- Filing and registration pathways for general and special cosmetics in China, including cross border e-commerce options
- How to avoid animal testing in China for cosmetics approvals
- Cosmetic ingredient submission code – what is it and why should cosmetics ingredients manufacturers consider filing
- New cosmetic ingredient registrations
- Recent key cosmetics regulations updates, especially relating to quality requirements and overseas factory inspections
- Chinese label requirements, local in China testing requirements, efficacy claim
- Local agent (Domestic Responsible Agent) requirements and 3 broad options available to Finnish companies
- Timelines and costs
Whos should attend
This event is aimed for Finnish manufacturer of medtech, cosmetics, cosmetic ingredients or health food which are trying to understand the complexities of registration.