G/TBT/N/VNM/82  
 
23 May 2016  
(16-2778)  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): Rigid Endoscopic 
Equipment (ICS:11.040) 
5. Title, number of pages and language(s) of the notified document: National technical 
regulation on the basic safety of Rigid Endoscopic Equipment (11 pages, in Vietnamese)     
6. Description of content: This regulation applies to agencies, organizations and individuals 
that produce, export, import and use the endoscopic equipment for medical purposes in the territory of Vietnam. This regulation de fines safety requirements of the endoscopic 
equipment and the enclosed portion of endosco pic equipment used together or separately 
for a medical purpose. 
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 Decemb er 06, 2011, Ministry of Health promulgated 
Circular No. 44/2011/TT-BYT on the list of produc ts and goods likely to be unsafe subject 
to the management assigned to the ministry of health. In this Circular, rigid endoscopic 
equipment is in the group of goods likely to become unsafe. Currently, hard endoscopic equipment is being imported widely and used in medical facilities. Therefore, technical standards defining safety criteria for Rigid Endoscopic Equipment should be developed to 
help ensure the quality thereof duri ng the examination and treatment. G/TBT/N/VNM/82 
 
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  8. Relevant documents:  TCVN 7303-2-18:2006 (IEC 60601-2-18:1996) Medical electrical 
equipment - Part 2-2: Particular requirem ents safety Specification for endoscopic 
equipment. 
IEC 60601-2-18:2009 Medical Electrical Equipment – Part  2-18: Particular requirements 
for the basic safety and essential performance of endoscopic equipment 
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. 
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 [  ] 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%20c ho%20QCKT/QCKT/QCK T%20noi%20soi.rar