| THE MINISTRY OF HEALTH ------- | SOCIALIST REPUBLIC OF VIET NAM Independence - Freedom - Happiness ---------- |
| No. 13/2010/TT-BYT | Hanoi, May 12, 2010 |
CIRCULAR
GUIDING THE MANAGEMENT OF QUICK FOOD TEST KITS
THE MINISTRY OF HEALTH
Pursuant to the July 26, 2003 Ordinance on Food Hygiene and Safety;
Pursuant to the Government's Decree No. I63/2004/ND-CP of September 7, 2004, detailing a number of articles of the Ordinance on Food Hygiene and Safety;
Pursuant to the Government's Decree No. 188/2007/ND-CP of December 27, 2007, defining the functions, tasks, powers and organizational structure of the Ministry of Health;
The Ministry of Health guides the management of quick food test kits as follows:
1. GENERAL PROVISIONS
Article 1. Scope of regulation
1. This Circular stipulates the assay, circulation registration, advertisement, labeling and use of quick food test kits.
2. Before circulation in Vietnam, all quick food test kits, produced at home and produced overseas and imported into Vietnam (excluding those temporarily imported for re-export), must be granted circulation registration certificates and numbers by the Ministry of Health for testing food hygiene and safety assessment indicators.
Article 2. Subjects of application
This Circular applies to enterprises producing, trading in, importing or distributing testing chemicals and instruments (below referred to as enterprises) when they request circulation registration of quick food test kits in Vietnam.
Article 3. Interpretation of terms
In this Circular, the terms below are construed as follows:
1. A quick food test kit consists of tools, chemicals or culturing media which are ready-made and complete for testing one or several given food hygiene and safety indicators and giving a result within a shorter time compared to standard testing methods.
2. Circulation registration means a process of carrying out prescribed procedures for appraising the scientificity, practicality and preciseness of a quick test kit and the lawfulness of the dossier of request for registration in order to permit circulation by issuing a circulation registration certificate and number.
