Thông tư 42/2016/TT-BYT về thừa nhận kết quả phân loại trang thiết bị y tế

THE MINISTRY OF HEALTH 

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

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 Appendix 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:

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:

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 takes effect on January 01, 2017.

Any issue arising in the course of implementation of this Circular should be promptly reported to the Department of medical Equipment and Construction- Ministry of Health. /.

For the Minister

The Deputy Minister

Nguyen Viet Tien

APPENDIX

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:

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