Registration for Domestic Devices Domestically made devices, on the other hand, generally require

Registration for Domestic Devices

Domestically made devices, on the other hand, generally require product registration.

A dossier for new product registration for domestically made devices includes the following documents:

• License of operation with testimony of meeting hygiene, safety and quality standards or cosmetic good manufacture practice certificate;

• Business registration certificate or investment certificate of organization or individual to register the product;

• Certificate of mandate signed by the manufacturer if the organization or individual to register the product is not the manufacturer;

• Composition: A detailed listing all chemical ingredients in generic or International Nonproprietary Names together with their concentration or percentage; and

• Quality standards as well as methods of testing.

For domestically made products, the language of the dossier should be either Vietnamese and/or English. One dossier is used to apply for registration for each product family.