The circular 42/2016/TT-BYT on recognition of medical device classification results

The circular 42/2016/TT-BYT on recognition of medical device classification results

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. List of countries which Vietnam acknowledges the classification results of medical equipment

List of countries which Vietnam acknowledges the classification results of medial equipment is implemented under the enclosed Appendix of this Circular.

Article 2. Conversion guidelines for the acknowledged results

1. Conversion guidelines for the classification results of medical equipment which is not in vitro diagnostics medical equipment:

Example: The classification result of the medial equipment in other countries under class I, shall be acknowledged in Vietnam to be the class A medical equipment.
2. Conversion guidelines for the classification results of the in vitro diagnostics medical equipment:

Article 3. Guidelines on using the probative documents of the classification results
1. In case the medical equipment is classified in one of the countries under Article 1 of this Circular and the classification result is presented in one of these following documents, it is not required to include the local classification of medical equipment in the declaration of specification or registration dossiers:
a) Certificate of Free Sale
b) Marketing Authorization
c) Export License
d) Other documents issued by the foreign competent authorities, including the classification results proclaimed in official websites of foreign competent authorities
2. Requirements for the probative documents of the classification results regulated in clause 1 of this Article:
Legalized documents or the notarized copies of the legalized documents are required.
In case the documents are not in English, it is required to enclose the Vietnamese translation copy. The translation copy is certified according to current laws and regulations.
In case the classification results are proclaimed in official websites of foreign competent authorities, when submitting the declaration of specification dossier or registration dossier for medical device, the applicant must submit the printed copies of classification results from the websites, certified with the applicant’s stamp and provide the authority with data source to look for the conformity of these documents.
Article 4. Implementation
This Circular takes effect from January 1st, 2017

During the implementation, any difficulty or query should be notified to the Ministry of Health (Department of Medical Equipment and Construction) to consider and solve.

Appendix

LIST OF COUNTRIES WHICH VIETNAM ACKNOWLEDGES THE CLASSIFICATION RESULTS OF THE MEDICAL EQUIPMENT

 (Enclosed with Circular No. 42/2016/TT/BYT on 15/11/2016 of Minister of Health)

1. List of the countries of the Association of Southeast Asian Nations:

• Republic of Indonesia;
• Lao People’s Democratic Republic;
• Republic of Philippines;
• Republic of Singapore;
• Federation of Malaysia
• Federation of Myanmar;
• Kingdom of Brunei;
• Kingdom of Cambodia;
• Kingdom of Thailand;

2. List of countries of European region:

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

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. List of countries which Vietnam acknowledges the classification results of medical equipment

List of countries which Vietnam acknowledges the classification results of medial equipment is implemented under the enclosed Appendix of this Circular.

Article 2. Conversion guidelines for the acknowledged results

1. Conversion guidelines for the classification results of medical equipment which is not in vitro diagnostics medical equipment:

Example: The classification result of the medial equipment in other countries under class I, shall be acknowledged in Vietnam to be the class A medical equipment.
2. Conversion guidelines for the classification results of the in vitro diagnostics medical equipment:

Article 3. Guidelines on using the probative documents of the classification results
1. In case the medical equipment is classified in one of the countries under Article 1 of this Circular and the classification result is presented in one of these following documents, it is not required to include the local classification of medical equipment in the declaration of specification or registration dossiers:
a) Certificate of Free Sale
b) Marketing Authorization
c) Export License
d) Other documents issued by the foreign competent authorities, including the classification results proclaimed in official websites of foreign competent authorities
2. Requirements for the probative documents of the classification results regulated in clause 1 of this Article:
Legalized documents or the notarized copies of the legalized documents are required.
In case the documents are not in English, it is required to enclose the Vietnamese translation copy. The translation copy is certified according to current laws and regulations.
In case the classification results are proclaimed in official websites of foreign competent authorities, when submitting the declaration of specification dossier or registration dossier for medical device, the applicant must submit the printed copies of classification results from the websites, certified with the applicant’s stamp and provide the authority with data source to look for the conformity of these documents.
Article 4. Implementation
This Circular takes effect from January 1st, 2017

During the implementation, any difficulty or query should be notified to the Ministry of Health (Department of Medical Equipment and Construction) to consider and solve.

Appendix

LIST OF COUNTRIES WHICH VIETNAM ACKNOWLEDGES THE CLASSIFICATION RESULTS OF THE MEDICAL EQUIPMENT

 (Enclosed with Circular No. 42/2016/TT/BYT on 15/11/2016 of Minister of Health)

1. List of the countries of the Association of Southeast Asian Nations:

• Republic of Indonesia;
• Lao People’s Democratic Republic;
• Republic of Philippines;
• Republic of Singapore;
• Federation of Malaysia
• Federation of Myanmar;
• Kingdom of Brunei;
• Kingdom of Cambodia;
• Kingdom of Thailand;

2. List of countries of European region:

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