Công văn 1275/BYT-TB-CT

To: Representative offices, importers and traders in medical equipment
(referred to as concerned entities)

Pursuant to the Circular No. 30/2015/TT-BYT dated October 12, 2015 of the Ministry of Health providing for import of medical equipment.

Pursuant to the Decision No. 5007/QD-BYT dated November 23, 2015 of the Minister of Health applying ASEAN Single Window Mechanism and Vietnam National Single Window Mechanism to the execution of administrative procedures for issuance of permits for import of medical equipment.

As of November 30, 2015, the Ministry of Health has got the cooperation with the General Department of Vietnam Customs to develop the Vietnam National Single Window Mechanism for carrying out administrative procedures for issuance of permits for import of medical equipment, organize two conferences for disseminating the Circular No. 30/2015/TT-BYT and providing training for importers in applying the Vietnam National Single Window Website to execute administrative procedures for issuance of import permits in Hanoi City and Ho Chi Minh City, and promulgate written guidance on use of the Vietnam National Single Window Website (address: https://vnsw.gov.vn) including registering for accounts, applying procedures for issuance of import permits and registering for digital signatures.

By means of applying the single window customs software to execute administrative procedures for issuance of medical equipment, the importers have been facilitated and supported in carrying out the declaration and application for import permits such as: accessing information and updating application status in a prompt way, saving time and costs, etc. Especially, it’s more convenient for geographically remote importers such as those located in Ho Chi Minh City and southern Vietnam. Additionally, period for issuing import permits is shortened.

During the implementation of single window mechanism, many entities have carried out research, and strictly and sufficiently complied with guidance and regulations of the Ministry of Health. However, many entities still do not pay attention to research, updating and compliance with new regulations of the Circular No. 30/2015/TT-BYT and relevant regulations and guidance on application and use of software in the national single window website resulting in many difficulties in the application processing job and software efficiency.

For the purpose of assisting relevant entities in grasping and implementing disseminated regulations and guidance, the Ministry of Health (Department of Medical Equipment and Health Facilities) does announce and request as follows:

1. Importers are responsible for carrying out detailed research on regulations and requirements on the application and procedures for issuance of import permits as regulated in the Circular No. 30/2015/TT-BYT the Official Dispatch No. 9228/BYT-TB-CT dated November 25, 2015 and the Official Dispatch No. 102/BYT-TB-CT dated January 08, 2016 of the Ministry of Health providing for the execution of import procedures according to single window mechanism and the implementation of the Circular No. 30/2015/TT-BYT and guidance on account registration, guidance on applying procedures for issuance of import permits and registering for digital signatures which have been published on the Vietnam National Single Window Website for avoiding correction or supplementation of documents due to failure to carry out research on disseminated and trained regulations and guidelines.

2. As for the application for import permit: The importer shall bear responsibility for the sufficiency, validity, accuracy and legal requirements on such application as regulated in the Circular No. 30/2015/TT-BYT and also bear responsibility for retaining submitted application for the purpose of tracing their sources, origin and ensuring quality management of medical equipment as regulated by laws.

3. Importers must strictly comply with regulations and provide sufficient contents concerning technical documents describing models of imported medical equipment which must be certified by affixing the importers’ seals as regulated in the Annex No. IV of the Circular No. 30/2015/TT-BYT

4. For the purpose of avoiding the importers' correction and supplementation of documents due to errors in software-added declaration, the Ministry of Health promulgates under this Official Dispatch the guidelines and notes for using the software on the Vietnam National Single Window Website in order that relevant entities can grasp and implement relevant regulations (guidelines are attached herewith).

Relevant entities are requested to strictly implement the aforesaid contents. Difficulties that arise during the implementation of this Official Dispatch must be reported to the Ministry of Health (via Department of Medical Equipment and Health Facilities) at telephone number: 04.62732272 or email: [email protected].

GUIDELINES

(Attached to the Official Dispatch No.:………./BYT-TB-CT dated March……, 2016 of the Ministry of Health)

1. Account information:

The following information must be sufficiently and exactly specified: tax code, address, representative, enterprise's name in Vietnamese and abbreviated name (sufficiently specify in capital letters) in conformity with the contents stated in the enterprise’s business registration certificate/investment certificate.

2. Information included in the application for import permit:

- Type of application: Select correct form of the application for import permit: new issuance, amendment or renewal.

- Headings of equipment: Based on medical equipment requiring import permit, select correct headings of such equipment according to the List of medical equipment stated in Annex I of Circular No. 30/2015/TT-BYT

- Name of equipment: Information concerning each type of imported medical equipment must be specified in Vietnamese letters in lower case according to the List of medical equipment stated in Annex I of the Circular No. 30/2015/TT-BYT It is not allowed to use an English name, trade name, brand’s name, or list code or model of product, or aggregate different names of imported medical equipment.

Examples:

Correct: “Máy Điện não”;

Wrong: “Máy Điện não EEG”, “Máy Điện não VIRGO-24”, “Máy Điện não (Electroencephalograph)”, “Máy Điện não và Máy Điện cơ”, “Máy Đo và phân tích Điện não”.

- Model It’s requested to provide sufficient information in conformity with the contents included in the certificate of free sale. Name of imported medical equipment shall not be specified in the description of equipment model. In case many models of the same type of imported medical equipment are stated in the certificate of free sale, information concerning such models must be sufficiently specified and separated from each other by a semicolon “;”.

Notes: Product models are put into attached annex in case the imported medical equipment includes product models or HS codes, or the imported medical equipment is a system that includes many parts which cannot be listed in the part of model-concerned information of the application for import permit.

- Manufacturer or country thereof: Information must be exactly and sufficiently specified according to the contents stated in certificate of quality; manufacturer and country thereof shall be separated by a comma “,”. Examples: Correct: Siemens, Germany; Wrong: “Siemens/ Germany” or “Siemens/ Nhật Bản, Japan”.

- Owner or country thereof: Information must be exactly and sufficiently specified according to the contents stated in certificate of free sale and certificate of quality; the manufacturer and thereof shall be separated by a comma “,”.

- Distributor or country thereof (if any): Is an entity in foreign country who is authorized by the owner (if any) to carry out the distribution of medical equipment. The importer must exactly and sufficiently declare information in conformity with the contents stated in certificate of free sale and the owner’s power of attorney; not specify information concerning distributors in Vietnam or may leave such part blank if there is no information of distributor.

Examples:

Correct: Gold Lite Pte Ltd, Singapore;

Wrong: “Công ty TM&DVKT LT, Việt Nam”.

- Duration of power of attorney: Duration of power of attorney must be correctly and exactly specified according to the duration stated in the power of attorney which is included in the application for import permit. In case the owner grants authorization through many different entities, the duration of power of attorney shall apply the latest duration of one of powers of attorney.

3. Attached files:

- Documents included in the application for import permit of medical equipment shall be scanned in color form after all requirements regulated in the Circular No. 30/2015/TT-BYT have been performed. In case of notarized document, all pages of such document must be scanned with the notary’s stamp affixed in each page or the notary’s seal affixed on adjoining edges of all pages.

- Names of attached files must show contents as stated the application for import permit. Examples: Giay chung nhan CFS_model A, Giay chung nhan CFS_model B, C, D, Giay chung nhan ISO 13485, Giay uy quyen, Giay dang ky DN.

- Certificate of free sale and power of attorney must be arranged in order and scanned and saved as one file only.

Note: Each attached file must contain the whole document (the document must be not divided into separate files.

Examples:

Correct: Power of attorney including 03 pages must be scanned and attached as one file only.

Wrong: Divided into 3 attached files.

- In case the owner grants many powers of attorney to the importer, such powers of attorney must be arranged in order, scanned and saved as one file, including the owner’s powers of attorney granted to distributors and importer.

- In case the certificate of free sale includes many pages and cannot be scanned in one file due to its large size or cannot be uploaded onto software, the importer may scan the certification page and the pages including information concerning models of imported equipment (which has been marked) and save them as one file, and the importer may be requested to provide the original for comparison as regulated by laws.

- In case the application must be carried according to attached annex, the importer shall download form of annex from the software and fill information according to regulated form, leave columns without information blank (examples: HS codes, packing specifications or calculation unit or distributor or country thereof). The completed form shall be saved in .pdf format and uploaded onto the software. Information other than that included in regulated form should be not specified.

- Do not download files that are inconsistent with required contents of the application for import permit or inconsistent with file contents stated in the software./.