Registration for Food & Dietary Supplement

Some countries require foods or dietary supplements to be registered with the relevant authorities before they can be distributed, while others may not have such registration requirements.

We provide local product registrations based on the regulations of the target market, covering countries around the world. It is essential to check the regulations of the target country, as products that are not registered may be denied customs clearance.

NOTE: If necessary, our specialists can assist with RP (Responsible Person) duties, reviewing required document, BMF (Batch Master File) documentation, product testing management, or any other services you may require.

Key Stage of Registration

Our team provides comprehensive registration services for manufacturing establishments and products according to the regulations of the target market, but this is not limited to these services. We assist in reviewing required documents, managing necessary laboratory testing, and offer timely updates on the registration process.

ㆍ   Document preparation: Prepare and review the required documents for registration in accordance with the regulations of the target market. Some reports may be necessary, such as distribution/sales history, intake history, safety assessments (including repeated-dose toxicity tests, research papers, and literature), and stability test reports, depending on the regulations and product classification of the target market. In such cases, expert assistance may be required. Engaging with our specialists can be more efficient in terms of both time and cost, ensuring that your registration process meets all regulatory requirements smoothly and effectively.

ㆍ   Establishment registration: Submit the necessary documents for establishment registration, including the factory business license, to the relevant authorities. There may be a requirement for a local corporation or RP (Responsible Person, U.S. Agent, and etc.) who can assume local responsibility depending on the target market.

ㆍ   Product registration: Submit the necessary documents for product registration, including the manufacturing flowchart, Certificate of Analysis (COA), labels, and Certificate of Origin (COO), to the relevant authorities. There may also be requirements for product technical file, which can include the Batch Master File (BMF) or other additional report depending on the regulations and product classification of the target market.

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> U.S. FDA compliance

> EU EFSA compliance

Our Service for Food & Dietary Supplement (Health Functional Food) Product      

	GAP Analysis		Ingredients and Label		Registration
	U.S. Agent		Facility Inspection		Food Safety
	Batch Master File		GRAS, NDI and Novel Food		Food Contact Substance

K-GMP supports international clients in safeguarding the quality, safety, and performance of their supply chain, ensuring full regulatory compliance from raw materials and ingredients through to packaging and final products.

K-GMP network offers a comprehensive range of 1:1 customized consultancy support for all types of food products. We are committed to staying up-to-date with the regulatory environment, trends and industry requirements.

For detailed information about each of the services above, contact directly our expert.

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