Circular No. 42/2016/TT-BYT on recognizing the classification results of medical devices

CIRCULAR

REGULATIONS ON THE RECOGNITION OF CLASSIFICATION RESULTS FOR MEDICAL DEVICES

THE MINISTER OF HEALTH

Pursuant to DecreeNo. 63/2012/NĐ-CP August 31, 2012 of the Government on the functions, tasks, powers, and organizational structure of the Ministry of Health;ình |government on medical devices;

Pursuant to Decree No.36/2016/NĐ-CP May 15, 2016 of the Government on the management of medical devices;ình |ủ về quản lý |ýof medical devices;

At the request of the Director of the Department of Medical Equipment and Works, Ministry of Health,Re4. The Ministers, Heads of ministerial-level agencies, Heads of government-affiliated agencies, the People's Committee of Haiphong City, the People's Committee of Can Tho City, the People's Committee of Nghe An Province, the People's Committee of Thanh Hoa Province, and the Heads of related units are responsible for implementing this Decision.ế, |

The Minister of Health issues this Circular to regulate the recognition of classification results for medical devices,

Article 1. List of countries whose classification results for medical devices are recognized by Vietnam

The list of countries whose classification results for medical devices are recognized by Vietnam shall be implemented according to the provisions set out in the Appendix attached hereto.

Article 2. Guidelines for converting recognition results

1. Guidelines for converting classification results for medical devices that are not in vitro diagnostic medical devices:

Example: For medical devices classified as Class I in these countries, the classification result recognized in Vietnam will be Class A.

2. Guidelines for converting classification results for in vitro diagnostic medical devices:

Article 3. Guidelines for using documents proving classification results

1. In cases where medical devices have been classified in one of the countries specified in Article 1 of this Circular and the classification result is reflected in one of the following documents, there is no need to submit the classification document for medical devices when submitting the standard application announcement or registration circulation file:

a) Free Circulation Certificate;

b) Registration Certificate;

c) Export Permit;

d) Other documents issued by foreign competent authorities, including classification results published on the website of the foreign competent authority.

2. Requirements for documents proving classification results as stipulated in Clause 1 of this Article:

Submit a legalized copy or a certified true copy of the legalized original.

If the proof document is not in English, it must be accompanied by a Vietnamese translation. The translation must be certified in accordance with the law.

If the classification result is published on the website of the foreign competent authority, when submitting the standard application announcement or the application for circulation number, the entity named in the standard application announcement or the application for circulation number must submit a printed version of the classification result from the website with the stamp of confirmation from the unit responsible for the content and data source so that the receiving unit can verify the validity of these documents.

Article 4. Effective date

This Circular takes effect from January 1, 2017. During the implementation process, if there are difficulties or obstacles, please report them to the Ministry of Health (Department of Medical Equipment and Works) for consideration and resolution./.