Chapter 1 Registration Background

1.1 Eaa and Introduction

Health care products are generally regulated by the local health administration and supervision department or drug supervision and administration department, and may be regulated by other departments in some countries or regions according to the different efficacy claims and ingredients, combined with the classification requirements of local laws and regulations.

1.2 Supervision and regulation

Comply with local regulations。

1.3 Definition of health care products&sort

The Codex Alimentarius Commission (CAC) Guidelines on Vitamin and mineral food supplements: Vitamins and/or minerals from which they are contained in the form of concentrated nutrients, either alone or in combination, displayed or sold in the form of capsules, tablets, powders and solutions, etc., which should be taken in the indicated dose units and should not be consumed in the traditional way of food intake, intended to supplement the vitamins and/or minerals in the normal diet of food. Each country or region basically refers to the definition of this form.

Classification basis of health care productsFor health care productsClaims that, depending on differences in national or regional regulations, may be considered pharmaceuticals or other categories of products.

1.4 Entry requirement

Local representativePower of attorneyLOA（Refer to local regulations for specific requirements）。

Free sale certificateFSC（Refer to local regulations for specific requirements）

Manufacturer and local importer information。

GMPCompliance certificate（Refer to local regulations for specific requirements）。

Product formulation。

Manufacturing process document。

Raw material analysis report。

Finished product analysis report。

Label and packaging。

In addition, there are generally required product stability research reports and product quality inspection reports.

1.5 Registration language

 The common language is English, but different countries or regions may have local language requirements.

Chapter 2 Registration process, cycle & Government fee

2.1 Registration flow chart

Some countries and territories may require local testing.

2.2  Registration period and official fees

As required by local regulations.

Chapter 3 Information that may be required

3.1 Halal Certificate

The certification process for the procurement, storage, processing, packaging, transportation and other processes of products in the fields of food, medicine, cosmetics and other fields according to Halal standards and regulations is called halal certification. Products certified as Halal are suitable for use and consumption by Muslim consumers.

There is a growing global demand for Halal Certification products. The Halal market reaches 1.9 billion Muslims in 112 countries and is estimated to be worth trillions of dollars.

Currently, the two largest markets for Halal products are Southeast Asia and the Middle East. There are 400 million Muslim consumers in these regions. Halal Certification has greatly increased the sales of products in these regions.

3.2 BSE Free certificate

At present, the international attention to cattle source materials is relatively high, health products may involve related materials, some countries will require explanations such as the source of gelatin materials, or provide BSE certificate.