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

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recognition of medical device classification results
The circular 42/2016/TT-BYT on recognition of medical device classification results
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The circular 42/2016/TT-BYT on recognition of 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. 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:
Classification of medical equipment in other countries Conversion result of the classification in Vietnam
The countries of ASEAN The countries of European region Australia Canada Korea Japan USA
A I I I 1 I I A
B IIa IIa II 2 II B
C IIb IIb III 3 III C
D III III IV 4 IV III D

 

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:

Classification of medical equipment in other countries Conversion result of the classification in Vietnam
The countries of ASEAN Australia Canada Korea Japan USA
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. 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.

Recipients

– Office of the Government (Official gazette department; Government Web Portal)

– Ministry of Justice (Agency of Examination of Legal Normative Documents, Agency of Administrative Procedure Control)

– Ministries, ministerial-level agencies, agencies attached to the Government;

– Deputy Ministers of Health;

– The People’s Committees of provinces, cities under Central Government;

– Service of Health of provinces, cities under Central Government

– Vietnam Association of medical equipment;

– Departments, Agencies, General Departments, Ministry Office, Ministry Inspectorate

– Web portal of Ministry of Health;

– Filing: Admin dept., Legal Affairs dept., DIMEC (03 copies)

 

PP. MINISTER

DEPUTY MINISTER

Nguyen Viet Tien

 

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;
  1. List of countries of European region:
–         Republic of Austria

–         Republic of Poland;

–         Republic of Portugal

–         Republic of Bulgaria;

–         Republic of Croatia;

–         Republic of Estonia;

–         Republic of Hungary;

–         Republic of Greece

–         Republic of Ireland;

–         Republic of Latvia;

–         Federal Republic of Germany

–         Republic of Lithuania;

–         Republic of Malta;

–         Republic of Finland

–         Republic of France;

–         Republic of Romania;

–         Republic of Czech;

–         Republic of Cyprus;

–         Republic of Slovakia;

–         Republic of Slovenia;

–         Republic of Spanish;

–         Republic of Italy;

–         Grand Duchy of Luxembourg;

–         Federation of Switzerland;

–         United Kingdom;

–         Kingdom of Belgium;

–         Kingdom of Denmark;

–         Kingdom of Holland;

–         Kingdom of Sweden.

 

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

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