G/TBT/N/VNM/80  
 
20 May 2016  
(16-2769)  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 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  
 
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): High Frequency 
Surgical Equipment (ICS: 11.040) 
5. Title, number of pages and language(s) of the notified document: National technical 
regulation on the basic safety of high frequency surgical equipment (12 pages, in Vietnamese) 
6. Description of content: This regulation applies to agencies, organizations and individuals 
that manufacture, export, import and use the High Frequency Surgical Equipment for 
medical purposes in the territory of Vietnam. The regulation defines safety requirement of 
high frequency surgical equipment in medical purpose. It does not apply to equipment which have rated output power less than 50W. 
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 Decemb er 2011, the 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, high frequency surgical equipment is listed in products and goods Group No. 2 Equipment of direct 
intervention on the patient. In addition, high frequency surgical equipment are now being 
imported into Vietnam and more widely used in the medical facilities. Therefore, technical standards defining safety criteria for high frequency surgical equipment should be 
developed to ensure the quality thereof during manufacturing, importing and use. G/TBT/N/VNM/80 
 
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  8. Relevant documents:   
TCVN 7303-2-2:2006 (IEC 60601-2-2:1998) Medical Electrical Equipment - Part 2-2: 
Particular requirements for the basic safety and essential performance of high frequency 
surgical equipment. 
IEC 60601-2-2:2009 Medical Electrical Equipment – Part 2-2: Particular requirements for 
the basic safety and essential performance of high frequency surgical equipment and high 
frequency surgical accessories. 
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: 2 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: http://www.moh.gov.vn   
Or can be downloaded at:  
 
http://tbt.gov.vn/Ti%20liu%20upload%20c ho%20QCKT/QCKT/QCK T%20dao%20mo%20die
n.rar