Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
ElendiLabs
Hong Kong
ElendiLabs specializes in medical device regulatory affairs in Hong Kong, providing comprehensive support for MDACS registration and compliance.
Qualtech Consulting Corporation
Taiwan, China, Japan, Singapore, Hong Kong, Malaysia, Philippines, Vietnam, Australia, Germany, Korea, Thailand, USA
A specialized medical device consulting firm offering a one-stop solution for complex global regulatory challenges. We offer real-time regulatory and clinical support, local representation, and QMS services across 13 markets, ensuring efficient market entry and compliance.
Registrar Corp
Hampton, Virginia (HQ), Shenzhen, China, London, United Kingdom, Paris, France, Madrid, Spain, Hyderabad, India, Kuala Lumpur, Malaysia, Tel Aviv, Israel, Guatemala City, Guatemala, Cape Town, South Africa
A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.
CMIC Holdings Co., Ltd.
Tokyo, Japan (HQ), Osaka, Japan, Beijing, China, Seoul, South Korea, Taipei, Taiwan, Singapore, New York, USA, London, UK, Frankfurt, Germany, Sydney, Australia
We operate globally, specializing in accelerating the development, manufacturing, and commercialization of drugs and medical devices. Their expertise spans Phase I to IV clinical trials, regulatory affairs, quality assurance, and manufacturing, with a strong focus on the Japanese and Asian markets. Key services include clinical operations (CRO), manufacturing (CDMO/CMO), site management (SMO), and comprehensive health analysis and solutions.
January 10, 2024
Approximately 5 minutes
China Launches 'Beijing Model' for Legal Cross-Border E-commerce Drug Imports
China Launches 'Beijing Model' for Legal Cross-Border E-commerce Drug Imports
In a significant regulatory shift, Beijing Customs, in coordination with the Beijing Municipal Drug Administration and other departments, has successfully executed the nation's first smooth clearance of a cross-border pharmaceutical e-commerce product on December 31, 2019. This event marks the first time China has established a legal, formal B2C import pathway for pharmaceutical products, effectively breaking the ice on a long-standing prohibition.
The Need for Formalized Channels
Previously, pharmaceutical products and medical devices were generally excluded from cross-border e-commerce due to stringent import approval procedures. However, consumer demand for overseas medical goods was extremely strong, with the 'Personal Care and Health' category ranking second in sales on platforms like Amazon China Overseas Purchase.
This high demand was largely met through informal channels such as personal overseas shopping (Haitao) and unauthorized purchasing agents (Daigou). These non-formal channels presented serious risks:
- Low Traceability: Difficulty in tracking product origin and movement.
- Quality Risks: Lack of professional certification for transport and warehousing, increasing the risk of damage.
- Consumer Protection Deficit: No controlled professional guidance for use and no unified system for seeking compensation or handling recalls.
The 'Beijing Model' Solution
Targeting these issues, Beijing developed the "Beijing Model" to legalize and manage the B2C import of certain pharmaceutical products and medical devices within the positive list framework of cross-border e-commerce.
Key Features of the Beijing Model:
- Pilot Entities: Only enterprises registered in Beijing with dual qualifications (cross-border e-commerce platform and medical device online trading platform) are eligible.
- Quality Control: Establish a comprehensive risk prevention, quality assurance, and after-sales service system.
- Traceability: Implementation of the "One Item, One Code, Code-Sync Traceability" principle to ensure full quality control and traceability management.
- Benefit: This model is expected to meet the strong consumer demand for high-quality, long-tail, and personalized overseas medical products while upholding public health safety.
Concurrent Breakthrough: E-commerce Export Returns
Simultaneously, China officially launched customs supervision for cross-border e-commerce export returns. This new mechanism addresses the long-standing problem of "difficult returns" for exported e-commerce goods, which previously forced businesses to liquidate unsold items abroad at a loss.
Key Features of Export Return Supervision:
- Scope: Applies to parcel exports, exports from special customs supervision areas, and goods from overseas warehouses.
- Policy: Allows original export goods to be returned to China within one year, either individually or in batches.
- Efficiency: For goods not returning to the domestic market, they can be warehoused in special customs supervision areas for consolidation, repair, re-labeling, and re-export under bond.
This move creates a complete closed-loop logistics for cross-border e-commerce, ensuring consumers can "buy with confidence" and merchants can "sell with peace of mind," boosting the competitiveness of China's emerging e-commerce export sector.
Related Articles
Approximately 5 minutes
The Regulatory Balancing Act: Cross-Border E-commerce for Unapproved Drugs in China
Cross-border retail import allows Chinese consumers to buy overseas drugs not yet approved domestically, primarily via the less-regulated **Direct Purchase Import** channel. While this improves drug **accessibility**, it poses significant **safety risks** (lack of quality assurance, no professional guidance, difficult consumer rights protection). Regulators are managing this risk through controlled **pilot programs** in cities like Beijing and Henan, aiming to shift sales towards the stricter **Bonded Warehouse Import** model.
Approximately 5 minutes
Expanding China's Cross-Border Pharmaceutical E-commerce: Challenges and Policy Recommendations
China's cross-border pharmaceutical e-commerce reached **RMB 11 billion** in 2023, but supply severely lags demand, particularly for eye, skin, and pediatric products. National People's Congress delegates propose **expanding the Positive List** of approved drugs and supporting the **Personal Postal Purchase** (**行郵**) model to meet consumer need, while strengthening platform accountability to ensure drug safety and reduce reliance on grey market channels.