Thông tư 42/2016/TT-BYT

Circular No. 42/2016/TT-BYT dated November 15, 2016 regulation on recognition of medical device classification results

Nội dung toàn văn Circular 42/2016/TT-BYT regulation recognition medical device classification results


MINISTRY OF HEALTH
---------

SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
-------------

No: 42/2016/TT-BYT

Hanoi, November 15, 2016

 

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

Vietnamese equivalents

ASEAN countries

European countries

Australia

Canada

Korea

Japan

U.S

 

A

I

I

I

1

I

I

A

B

IIa

IIa

II

2

II

 

B

C

Ilb

Ilb

III

3

III

C

D

III

III

IV

4

IV

III

D

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

Vietnamese Equivalents

ASEAN countries

Australia

Canada

Korea

Japan

U.S

 

A

1

I

1

I

I

A

B

2

II

2

II

 

B

C

3

III

3

III

C

D

4

IV

4

IV

III

D

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

 

ANNEX

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.


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