List of Required Qualifications for Export Manufacturing of Finished Health Products

Core Foundations: Basic Domestic Production and Export Qualifications

Regardless of the export destination, the OEM factory must first possess compliant production and legal export credentials within China.

• Food Production License (SC Certification): This is the bare minimum for domestic production. The factory's production license must cover the dosage form of the product you wish to manufacture (e.g., tablets, capsules, powders, soft capsules, etc.).
• Foreign Trade Operator Registration Form: The factory itself must possess import and export rights to legally handle export customs declarations for finished products.
• Customs Registration Certificate for Importers and Exporters: Ensures the factory is registered in the customs system and can properly complete customs clearance procedures.

II. Internationally Recognized Authoritative Certification Systems

Overseas buyers and local regulatory agencies typically recognize the following major internationally recognized standards when auditing suppliers. These are also key indicators of a contract manufacturer's manufacturing capabilities and quality control:

1. GMP Certification (Good Manufacturing Practices)

• GMP (Good Manufacturing Practices) is the standard requirement for health supplement contract manufacturing.
• Note: For exports to the US market, factories must pass GMP certification, which imposes stricter requirements on aseptic techniques, equipment, and process control than standard GMP.

2. ISO Series International Quality Management Systems

• ISO 22000 / FSSC 22000: Certification specifically for food safety management systems, highly recognized in European and Asian markets.
• ISO 9001: Basic quality management system certification, demonstrating the factory's ability to consistently provide qualified products.

3. HACCP Certification

• Hazard Analysis and Critical Control Points (HACCP): A preventative system for addressing food safety risks. Although many countries have incorporated it into ISO 22000, holding a separate HACCP certificate remains a very strong endorsement for customs clearance in North America and Australia.

III. Precise Regional Adaptation

1. Export to the US Market:

The US dietary supplement market is large, but regulations are extremely stringent, primarily focusing on the following two points:

• FDA Registration: Foreign manufacturers exporting food/dietary supplements to the US must register with the FDA (Facility Registration). Note that the FDA does not issue "certificates" to factories; contract manufacturers need to provide a compliant registration number and regular update records.
• FSVP (Foreign Supplier Verification Program) Compliance: Factories must be able to cooperate with US importers to provide risk analyses and compliance documentation that comply with FDA FSMA (Food Safety Modernization Act) requirements.

2. Export to Europe (EU Market):

Europe has extremely high restrictions on the ingredients and labeling requirements for food supplements.

• EU Standard Registration/Filing: Factories must meet EU regulations (such as Regulation (EC) No 852/2004) in their production practices.
• EFSA (European Food Safety Authority) Compliance Certification: Ensures that the raw materials and plant extracts (such as pine bark, white willow bark, AHCC, etc.) used by the contract manufacturer are on the EU's "Permitted Use List" or have passed "Novel Food" certification.

3. Specific Cultural and Religious Markets (Globally Recognized Bonus)

If your target audience includes specific cultural groups, the following qualifications will be key to your product's market success:

• Halal Certification: An essential passport for exporting to Southeast Asia (such as Malaysia and Indonesia) or the Middle East.
• Kosher Certification: Among the middle class and Jewish communities in Europe and America, the Kosher mark is synonymous with high quality and extreme cleanliness.
• Vegan / Non-GMO Certification: A must-see for brands that follow the overseas plant-based health trend and have special requirements for capsule shells and raw material sources.