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Circular No. 46/2017/TT-BYT dated December 15, 2017 of the Ministry of Health on guidelines for the Government’s Decree No. 36/2016/ND-CP dated May 15, 2016 on management of medical equipment

Date: 12/15/2017

MINISTRY OF HEALTH
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SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness 
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No. 46/2017/TT-BYT
Hanoi, December 15, 2017
CIRCULAR
GUIDELINES FOR THE GOVERNMENT'S DECREE NO. 36/2016/ND-CP DATED MAY 15, 2016 ON MANAGEMENT OF MEDICAL EQUIPMENT
Pursuant to the Government's Decree No. dated June 20, 2017 defining functions, tasks, entitlements and organizational structure of the Ministry of Health;
Pursuant to the Government's Decree No. 36/2016/ND-CP dated May 15, 2016 on management of medical equipment;
At the request of Director of Medical Equipment and Work Department,
The Minister of Health promulgates a Circular to provide guidelines for the Government's Decree No. 36/2016/ND-CP dated May 15, 2016 on management of medical equipment (hereinafter referred to as “Decree No. 36/2016/ND-CP").
Article 1. Scope
This Circular provides for:
1. Cases in which submission of the clinical trial datasheet and clinical trial result is not required when applying for registration according to Clause 1k Article 26 of Decree No. 36/2016/ND-CP.
2. Cases in which submission of the certificate of inspection of vitro diagnostic devices is not required when applying for registration according to Point l Clause 1 Article 26 of Decree No. 36/2016/ND-CP.
3. List of Type B, C, D medical equipment that may be traded as if normal goods according to Clause 1 Article 39 of Decree No. 36/2016/ND-CP.
4. Presentation of technical manuals of domestic medical equipment according to Form No. 01 in Appendix VIII of Decree No. 36/2016/ND-CP.
5. Instructions on translation of the authorization letter in Appendix VI of Decree No. 36/2016/ND-CP.
Article 2. Cases in which submission of the clinical trial datasheet and clinical trial result is not required when applying for registration of medical equipment
1. Type C and Type D invasive equipment specified in Appendix I hereof.
2. Type C and Type D equipment that have been registered and have the certificate of free sale issued by any of the countries or organizations on the list in Appendix II hereof.
Article 3. Cases in which submission of the certificate of inspection of vitro diagnostic devices is not required when applying for registration
Type C and Type D equipment that have been registered and have the certificate of free sale issued by any of the countries or organizations on the list in Appendix II hereof.
Article 4. List of Type B, C, D medical devices that may be traded as if normal goods
1. List of Type B, C, D medical equipment that may be traded as if normal goods is provided in Appendix III hereof.
2. Traders of Type B, C, D medical equipment that may be traded as if normal goods are not required to make the declaration of eligibility to trade in medical equipment.
Article 5. Presentation of technical manuals
Contents of section 1.1 of the technical manual provided in Form No. 01 in Appendix VIII of Decree No. 36/2016/ND-CP:
1. Operation principles and specifications, international standards, Vietnam’s standards, national technical regulations and internal standards applied (these standards are the basis for inspection of effectiveness and safety of the medical equipment.
2. The internal standards used as the basis for inspection of effectiveness and safety of the medical equipment must satisfy the requirements specified in Circular No. 21/2007/TT-BKHCNon development and application of standards.
3. Sources of international standards (if any) must be specified.
Article 6. Translation of the authorization letter
Instructions on translation of the authorization letter in Appendix VI of Decree No. 36/2016/ND-CPin Appendix VI of Decree No. 36/2016/ND-CP are provided in Appendix IV hereof.
Article 7. Effect
This Circular comes into force from February 01, 2018.
Article 8. Transition
Technical manuals and authorization letters written in English language that are submitted together with the declaration of applied standards or application for registration and signed before the effective date of this Circular shall remain valid.
Article 9. Reference
In the cases where any of the documents referred to in this Circular is amended or replaced, the newer document shall apply.
Article 10. Implementation
Chief of the Ministry Office, Ministerial Chief Inspector, Directors of Departments affiliated to the Ministry of Health, Directors of Departments of Health, relevant organizations and individuals are responsible for the implementation of this Circular.
Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Health for consideration./.
 
 
PP MINISTER
DEPUTY MINISTER
(Signed and sealed)




Nguyen Viet Tien 
 
APPENDIX I
IMPORTED MEDICAL EQUIPMENT WHOSE CLINICAL TRIAL DATASHEETS AND CLINICAL TRIAL RESULTS ARE NOT REQUIRED WHEN APPLYING FOR REGISTRATION
1. Peritoneal dialysis catheter
2. Catheter
3. Catheter kit
4. Cannulae
5. Guidewire
6. Introducer
 
APPENDIX II
LIST OF COUNTRIES AND ORGANIZATIONS WHOSE MEDICAL EQUIPMENT IS EXEMPT FROM SUBMISSION OF CLINICAL TRIAL DATASHEETS, CLINICAL TRIAL RESULTS AND VIETNAM’S CERTIFICATE OF INSPECTION
1. European countries:
 
- Republic of Austria;
- Romania;
- Republic of Poland;
- Czech Republic;
- Portuguese Republic (Portugal);
- Republic of Cyprus;
- Republic of Bulgaria;
- Slovak Republic;
- Republic of Croatia;
- Republic of Slovenia;
- Republic of Estonia;
- Spain;
- Hungary;
- Italian Republic;
- Hellenic Republic (Greece);
- Grand Duchy of Luxembourg;
- The Republic of Ireland;
- Swiss Confederation (Switzerland);
- Republic of Latvia;
- Kingdom of England;
- Federal Republic of Germany;
- Kingdom of Belgium;
- Republic of Lithuania;
- Kingdom of Denmark;
- Republic of Malta;
- Kingdom of the Netherlands;
- The Republic of Finland;
- Kingdom of Sweden.
- French Republic;
 
2. FDA (USA).
 
3. Japan.
 
4. TGA (Australia).
 
5. Canada.
 
 
APPENDIX III
LIST OF TYPE B, C, D MEDICAL EQUIPMENT THAT MAY BE TRADED AS IF NORMAL GOODS WITHOUT SUBMISSION OF DECLARATION OF ELIGIBILITY TO TRADE IN MEDICAL EQUIPMENT
1. Type B home-use in vitro diagnostic devices
2. Personal blood pressure monitors
3. Electronic thermometers, infrared thermometers
4. Personal blood glucose monitoring devices: blood glucose monitors, lancing devices, test trips, lancets, control solutions
5. Nebulizers
6. Adhesive bandages
7. Artificial tears classified as medical equipment
8. Condoms
9. Vaginal contraceptive films (drug-free)
10. Vaginal lubricants
11. Electric heat bags
 
 (This translation is for reference only)



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