Draft Guiding on Implement Some Articles of Decree on Medical Devices No. 36/2016/NĐ-CP dated May 15, 2016

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Draft Guiding on Implement Some Articles of Decree 36
Draft Guiding on Implement Some Articles of Decree 36
Draft Guiding on Implement Some Articles of Decree on Medical Devices No. 36/2016/NĐ-CP dated May 15, 2016
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Draft Guiding on Implement Some Articles of Decree on Medical Devices No. 36/2016/NĐ-CP dated May 15, 2016

THE MINISTRY OF HEALTH

 

No.:         /2016/TT-BYT

THE SOCIALIST REPULBIC OF VIETNAM

Independence – Freedom – Happiness

Hanoi, August       , 2016

CIRCULAR

Guiding on Implement Some Articles of Decree on Medical Devices No. 36/2016/NĐ-CP dated May 15, 2016

Pursuant to Decree No. 63/2012/ND-CP dated 31/08/2012 of the Government defining functions, duties, powers and organizational structure of the Ministry of Health;

Pursuant to Decree No. 36/2016/ND-CP dated May 15, 2016 of the Government on medical devices management (called Decree 36/2016/NĐ-CP)

At the proposal set forth by the Medical equipment and construction Department – Minister of Health;

The Minister of Health issues the Circular providing for guiding on implement some articles of the Decree 36/2016/NĐ-CP, as follow:

Article 1: Guiding on announce the list of countries that Vietnam recognizes the results of classification of medical devices, specified in Article 10, number 2 of the decree 36/2016/NĐ-CP

Promulgated together with this circular is the list of countries that Vietnam recognizes the results of classification of medical devices, specified in Appendix I.

Article 2: Guiding on Class C and D invasive medical devices but do not request the summary of clinical trial data together with clinical trial research results, specified in article 26, number 1.k of the decree 36/2016/NĐ-CP

Promulgated together with this circular is the list of Class C and D invasive medical devices but do not request the summary of clinical trial data together with clinical trial research results, specified in Appendix II.

Article 3: Guiding on Class C or D vitro diagnostic medical devices that require local type testing, specified in article 26, number 1.a of the decree 36/2016/NĐ-CP

Promulgated together with this circular is the list of Class C or D vitro diagnostic medical devices that require local type testing, specified in Appendix III.

Article 4: Guiding on Class B, C, D medical devices included in the list of medical devices may be traded as normal goods, specified in article 39 of the decree 36/2016/NĐ-CP

Promulgated together with this circular is the list of Class B, C, D medical devices may be traded as normal goods, specified in appendix IV.

Article 5: Implementation

This Circular takes effect from….. 2016.

Any problem arising in the course of implementation of this Circular should be reported to the Ministry of Health (Department of Medical Equipment and Health Facilities) for review and settlement./.

Recipients:

– Government Office (Official Gazetter, Government e-portal)

– Government website

– Ministry of Justice (Dept. of legal document checking)

– Ministries, ministerial-level agencies, government agencies

– Vice Ministers of Ministry of Health

– People’s Committees of centrally-administered cities and provinces

– Health Department of provinces and central affiliated cities

– Medical devices Association

– Website of Ministry of Health

– Filed at: Records Management, legal department, MED (03 copies)

 

MINISTRER

Nguyen Thi Kim Tien

 

Annex I

LIST OF COUNTRIES VIETNAM RECOGNIZES THE RESULTS OF CLASSIFICATION OF MEDICAL DEVICES

(Promulgated together with circular No.:   / 201 / TT – BYT dated …. of Minister of Health )

Risk level Classification

in Vietnam

Classifications recognized by Vietnam
The member countries of the Association of Southeast Asian Nations1 The member countries of European Union2 Australia Canada Japan US
Low risk A A I I I General I
Low-moderate risk B B IIa IIa II Controlled  
Moderate-high risk C C IIb IIb III  
High risk D D III III IV III


1
List of member countries of the Association of Southeast Asian Nations: Brunei, Cambodia, Indonesia, the Lao People’s Democratic Republic, Malaysia, Myanmar, Philippines, Singapore, Thailand

2List of member countries of the European Union: Austria, Belgium, the Republic of Bulgaria, the Republic of Croatia, the Czech Republic, the Republic of Cyprus, the Kingdom of Denmark, the Republic of Estonia, the Republic of Finland, the French Republic, the federal Republic of Germany, the Republic of Greece, the Republic of Hungary, the Republic of Ireland, the Republic of Italy, the Republic of Latvia, the Republic of Lithuania, the Grand Duchy of Luxembourg, the Republic of Malta, the Netherlands, Republic of Poland, the Republic of Portugal, the Republic of Romania, the Republic of Slovakia, the Republic of Slovenia, the Republic of Spain, the Kingdom of Sweden.

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Appendix II

LIST OF INVASIVE MEDICAL DEVICES CLASSES C, D DO NOT REQUIRE TO SUBMIT SUMMARY OF CLINICAL TRIAL DATA AND CLINICAL STUDY RESULTS

(Issued together with Circular No.:       /2016/TT-BYT dated    month    year 2016 of Minister of Health)

———————————————————————————————–

Appendix III

LIST OF IN-VITRO DIAGNOSTIC MEDICAL DEVICES CLASSES C, D IS REQUIRED LOCAL TYPE TESTING

(Issued together with Circular No.:       /2016/TT-BYT dated    month    year 2016 of Minister of Health)

———————————————————————————————–

Appendix IV

LIST OF MEDICAL DEVICES BELONG TO CLASSES B, C, D IN LIST OF MEDICAL DEVICES ALLOWED TO PURCHASE, SELL AS COMMON GOODS

(Issued together with Circular No.:       /2016/TT-BYT dated    month    year 2016 of Minister of Health)

  1. Medical devices used in household.
  2. Equipment, tools for supporting and rehabilitation
  3. The equipment and hospital furniture
  4. Condoms
  5. Ambulance stretcher

Draft Guiding on Implement Some Articles of Decree 36

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