G/TBT/N/VNM/81  
 
20 May 2016  
(16-2771)  Page: 1/2  
Committee on Technical Barriers to Trade  Original: English  
 
  NOTIFICATION 
The following notification is being circulated in accordance with Article 10.6 
 
1. Notifying Member: VIET NAM  
If applicable, name of local government involved (Article 3.2 and 7.2):    
2. Agency responsible:  
Ministry of Health 
Department of Medical Equipment and Facilities 
138A Giang Vo Str., Ba Dinh Dist., Ha Noi City, Viet Nam 
Tel (84-4) 62732273 
Fax: (84-4) 38464051 
Email: byt@moh.gov.vn  
Website: www.moh.gov.vn  
Name and address (including telephon e and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above :   
3. Notified under Article 2.9.2 [ X ], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other:  
4. Products covered (HS or CCCN where applic able, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable): Infant Incubator 
(ICS:11.040) 
5. Title, number of pages and language(s) of the notified document: National technical 
regulation on the basic safety of Infant Incubator (20 pages, in Vietnamese)     
6. Description of content: This regulation applies to agencies, organizations and individuals 
that produce, export, import and use Infant Incubators for medical purposes in the territory of Viet Nam. This regulation defines safety requirements and limits on the accuracy of some parameters of infant incubators used for medical purposes. This 
regulation does not apply to mobile incubator used to move  infants. 
7. Objective and rationale, including the nature of urgent problems where applicable: 
Medical devices have direct impact on the health of patients, therefore the most concerned 
issue is the safety of the device. On 6 December 2011, Ministry of Health promulgated Circular No.44/2011/TT-BYT on the list of products and goods likely to be unsafe subject to 
the management assigned to the ministry of health. In this Circular, infant incubator, 
which is now being imported widely and used in medical facilities, is in the list of potentially unsafe commodities. This device directly relates to the health of children because it provides environmental essential co nditions to ensure the health of children. 
Therefore, technical standards defining safety criteria for Infant Incubator should be 
developed to help ensure the quality thereof during manufacturing, importing and using. G/TBT/N/VNM/81 
 
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  8. Relevant documents:   
TCVN 7303-2-19:2006 (IEC 60601-2-19:1990) Medical electrical equipment - Part 2-19: 
Particular requirements for the safety of baby incubators. 
IEC 60601-2-19:2009 Medical Electrical Equipment – Part 2-19: Particular requirements for 
the basic safety and essential performance of infant incubators. 
TCVN 6196-1:2008 (ISO 15223-1:2007/Amd 1:2008) Medical Devices – Symbols to be 
used with medical device labels, labelling and information to be supplied – Part 1: General 
requirements. 
TCVN 7303-1:2009 (IEC 60601-1:2005) Medical Electrical Equipment - Part 1: General 
requirements for basic safety and essential performance.  
9. Proposed date of adoption: 20 July 2016   
Proposed date of entry into force: 5 September 2016    
10. Final date for comments: 60 days after the date of notification 
11. Texts available from: National enquiry point [ X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:   
Ministry of Health 
Department of Medical Equipment and Construction 
138A Giang Vo Str., Ba Dinh Dist., Ha Noi City, Viet Nam 
Tel (84-4) 62732273 
Fax: (84-4) 38464051 
Email: byt@moh.gov.vn    
Website: www.moh.gov.vn  
 
Or can be downloaded at: 
http://tbt.gov.vn/Ti%20liu%20upload% 20cho%20QCKT/QCKT/Q CKT%20Long%20ap%20tr
e.rar