CIRCULAR NO 422016TT BYT DATED NOVEMBER 15, 2016 REGULATION ON RECOGNITION OF MEDICAL DEVICE CLASSIFICATION RESULTS

MINISTRY OFHEALTH ---SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness CIRCULAR REGULATION ON RECOGNITION OF MEDICAL DEVICE CLASSIFICATION RESULTS THE MINISTER OF HEAL

MINISTRY OF

HEALTH

-SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness

CIRCULAR

REGULATION ON RECOGNITION OF MEDICAL DEVICE CLASSIFICATION RESULTS

THE MINISTER OF HEALTH

Pursuant to the Government's Decree No 63/2012/ND-CP dated August 31, 2012 defining the functions, rights, responsibilities 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;

Upon request of the Director of the Department of Medical Equipment and Construction –Ministry

of Health,

The Minister of Health hereby issues this Circular stipulating regulation on recognition of medical device classification,

Article 1 Lists of countries whose medical device classification results are recognized by Vietnam

The list of countries whose medical device classification results are recognized by Vietnam is presented in the Annex attached hereto

Article 2 Guidelines for comparison of recognized classification results

1 Guideline for comparing classes of medical devices other than in vitro diagnostic medical devices:

Classification of medical devices by Classificati

on of medical devices byClassific ation of medical devices byClassific ation of medical devices byClassific ation of medical

devices byClassific ation of medical devices byClassific ation of medical devices byVietnam ese equivalents

ASEAN countries Europeancountries Australia Canada Korea Japan U.S

E.g.: A class I medical device classified according to other country's classification system shall be recognized as equivalent to a class A medical device according to Vietnam’s classification system

2 Guideline for comparing classes of in vitro diagnostic medical devices:

Classification of medical devices by

Classificatio

n of medical devices byClassificat ion of medical devices byClassificat ion of medical devices byClassificat ion of medical devices byClassificat ion of medical devices byVietnames e Equivalents

ASEAN countries Australia Canada Korea Japan U.S

B 2 II 2 II B

Article 3 Guideline for use of documents certifying medical device classes

1 The classification table is not required when applying for declaration of applicable standards or registration of free sale of a medical device which is classified by one of countries specified in Article 1 hereof and its classification result is presented in one of the following documents:

a) The certificate of free sale;

b) The certificate of registration;

c) The export license;

d) Other documents issued by the foreign countries’ State management authorities, including the classification results published on the websites on foreign countries’ competent authorities

2 Requirements for documents certifying classification results stipulated in clause 1 of this Article: Consularized copies or certified true copies of consularized copies shall be submitted to the consul

In case any certifying document is made in a foreign language other than English, a Vietnamese translation is required The translation shall be authenticated in accordance with regulations of laws

In case the classification result is published on the website of a foreign country’s competent

authority, the organization under its name the application for declaration of applicable standards and free sale certificate is made, when declares the applicable standards or applies for the free sale certificate, shall submit a copy of the classification result printed out from the website which is sealed as a confirmation by the entity taking responsible for the content and shall provide sufficient sources of data to the application-receiving entity for examination of the validity of such

documents

Article 4 Effect

This Circular enters into force from January 01, 2017

Any issue arising from implementation of this Circular should be promptly reported to the

Department of medical Equipment and Construction- Ministry of Health /

PP MINISTER DEPUTY MINISTER

Nguyen Viet Tien

LIST OF COUNTRIES WHOSE RESULTS OF MEDICAL DEVICE CLASSIFICATION ARE

RECOGNIZED BY VIETNAM

(Enclosed with the Circular No.42/2016/TT-BYT dated November 15, 2016 by the Minister of

Health)

1 The list of countries in the Association of Southeast Asian Nations:

- The Republic of Indonesia;

- Lao People's Democratic Republic;

- The Republic of the Philippines;

- The Republic of Singapore;

- The Federation of Malaysia;

- The Republic of the Union of Myanmar;

- The Nation of Brunei;

- The Kingdom of Cambodia;

- The Kingdom of Thailand

2 The list of European countries:

- The Republic of Austria - The Republic of Romania;

- The Republic of Poland; - The Czech Republic;

- The Portuguese Republic; - The Republic of Cyprus;

- The Republic of Bulgaria; - The Slovak Republic;

- The Republic of Croatia; - The Republic of Slovenia;

- The Republic of Estonia - The Spanish Republish;

- The Republic of Hungary - The Republic of Italy;

- The Republic of Greece - The Grand Duchy of Luxembourg;

- The Republic of Ireland; - The Swiss Confederation;

- The Republic of Latvia; - The United Kingdom;

- The Federal Republic of Germany; - The Kingdom of Belgium;

- The Republic of Lithuania; - The Kingdom of Denmark;

- The Republic of Malta; - The Kingdom of Holland;

- The Republic of Finland; - The Kingdome of Sweden

- The French Republic;

3 The United States of America, Japan, Korea, the Commonwealth of Australia and Canada.

-This translation is made by L aw S oft and for reference purposes only Its copyright is owned by

L aw S oft and protected under Clause 2, Article 14 of the Law on Intellectual Property.Your

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