Công văn 3593/BYT-TB-CT của Bộ Y tế về việc phối hợp hướng dẫn thực hiện quy định tại Nghị định 36/2016/NĐ-CP ngày 15/05/2016 của Chính phủ về quản lý trang thiết bị y tế

THE MINISTRY OF HEALTH

Official Dispatch No.3593/BYT-TB-CT dated June 23, 2017 of the Ministry of Health on guidelines for the Government’s Decree No.36/2016/ND-CP dated May 15, 2016 on medical device management.

To:General Department of Vietnam Customs

On May 15, 2016, the Prime Minister signs the Decree No. 36/2016/ND-CP on medical device management (hereafter referred to as Decree No. 36/2016/ND-CP),which comes into force from July 01, 2016. According to the Decree, there are some important changes inmedical device management. In particular:

Firstly, all medical devices shall be classified to be used as the basic for the declaration on applied standards or issuance of registration number.

According to Article 4 of Decree No. 36/2016/ND-CP, medical devices shall be classified into 2 groups and 4 types as follows:

-Group 1 includes Type A medical devices.

-Group 2 includes Type B, Type C and Type D medical devices.

Medical devices shall be classified by a qualified organization according to the instruction on classification of medical devices prescribed in the Circular No. 39/2016/TT-BYT dated October 28, 2016 on guidelines for classification of medical devices, except for the classification of medical devices is recognized according to the Circular No. 42/2016/TT-BYT dated November 15, 2016 on recognition of medical device classification results.

Secondly, the medical device management is based on the registration number

According to Article 20 of Decree No. 36/2016/ND-CP, registration number of a medical device includes:

-The number of the confirmation of submission of the application for the declaration of applied standards of Type A medical devices using the specimen 03 prescribed in Appendix IV issued together with the Decree No. 36/2016/ND-CP or

-The number of the certificate of registration of Type B, C or D medical devices using the specimen 09 prescribed in Appendix IV issued together with the Decree No. 36/2016/ND-CP.

Medical devices that have obtained registration number in Vietnam may be exported and imported without limits and are not required to be approved by the Ministry of Health.

In order to provide assistance to the importer in identification and customs clearance of imported medical devices in the beginning of the implementation of Decree No. 36/2016/ND-CP, the Department of Medical Equipment and Health Works (DMEHW), which is affiliated to the Ministry of Health, requests the General Department of Vietnam Customs to cooperate with, direct and notify Departments of Customs of provinces and central-affiliated cities of the following contents:

With regard to the import of medical devices:

1.From 0:00 on July 01, 2017 to 24:00 on December 31, 2017:

a) A Type A medical device shall only be imported if there is confirmation of submission of the application for declaration on applied standards issued by the Department of Health of the province or city. Apart from customs documents, the importer of medical devices shall provide the following documents:

-A written classification of medical devices using the specimen in Appendix V issued together with the Decree No. 36/2016/ND-CP or document proving the result of classification of medical devices as prescribed in the Circular No 42/2016/TT-BYT dated November 15, 2016 on recognition of medical device classification results.

-An authorization document of the holder of registration number if the importer and the holder of registration number are not the same.

b) A Type B, C or D medical device that is included in the list  of medical devices issued together with the Circular of the Ministry of Health No.30/2015/TT-BYT dated October 12, 2015 on import of medical devices shall only be imported if it obtains the following documents:

-An import license issued by the Ministry of Health in accordance with the Circular No. 30/2015/TT-BYT;

-A written classification of medical devices using the specimen in Appendix V issued together with the Decree No. 36/2016/ND-CP or document proving the result of classification of medical devices as prescribed in the Circular No 42/2016/TT-BYT dated November 15, 2016 on recognition of medical device classification results.

c) If a Type B, C or D medical device is not included in the list  of medical devices issued together with the Circular of the Ministry of Health No. 30/2015/TT-BYT, the importer will provide a written classification of medical devices using the specimen in Appendix V issued together with the Decree No. 36/2016/ND-CP or document proving the result of classification of medical devices as prescribed in the Circular No 42/2016/TT-BYT dated November 15, 2016 on recognition of medical device classification results.

2.From 0:00 on January 01, 2018

a) The import of Type A medical devices shall comply with regulations specified in I.1.a of this Official Dispatch.

b) A Type B, C or D medical device shall only be imported after the importer is issued with the certificate of registration by the Ministry of Health. The importer that is not the holder of registration number shall provide the authorization document of the holder of the registration number.

3.In vitro diagnostic medical devices that are issued with registration number before December 31, 2017 may be imported until the license expires.

4.Departments of Customs of provinces and central-affiliated city shall search information about registration numbers of medical devices and import licenses on the website Vietnam National Single Window to carry out procedures for customs clearance applied to importers of medical devices, avoid the request for written confirmations of the Ministry of Health, congestion and arising of administrative procedures and sub-licenses and reduce the time for getting permission for the import and export of medical devices.

The Ministry of Health requests the General Department of Vietnam Customs to cooperate and direct in order to provide assistance to importer in the customs clearance. Any problem arising from the implementation of this Official Dispatch shall be reported to the DMEHW via the phone number: 04.62732272 or email: vuttbctyt@gmail.com for cooperation.

Thanks for the cooperation of General Department of Vietnam Customs.

For the Minister

The Director of the Department of Medical Equipment and Health Works

Nguyen Minh Tuan