PROCEDURES FOR IMPORTING THE COVID TEST KIT
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Applying for a license to import a covid test kit or an import procedure for a covid test kit is a hot topic of interest in recent times when the epidemic situation is unpredictable.
ASC Logistics is a unit applying for an import license from the Ministry of Health, customs services, customs procedures specializing in imported medical equipment. We will guide the procedure to import the covid test kit in the article below.
The covid test kit is a kit that can test for the new strain of corona virus in samples from nasopharyngeal fluid, throat rinse, pleural fluid or blood samples. This test kit is especially important during the outbreak of the disease and is an effective tool to support testing, tracing and locating patients in our country and around the world.
Because of that importance, the test kit is rigorously tested in accordance with the law when granting an import license or carrying out procedures to import the covid test kit into Vietnam. And at the time of the outbreak of the epidemic, the state also gave full support, creating favorable conditions for businesses accompanying the government to import covid test kits to help contain the epidemic and control the epidemic quickly.
Procedures for importing a covid test kit include:
- Apply for an import license from the Ministry of Health (Department of Equipment and Works).
- Carrying out import customs procedures.
I, Apply for a license to import covid test kits from the Ministry of Health:
Documents to be provided when applying for a permit to import a covid test kit from the Ministry of Health:
- Speaker: Authorization letter from owner
- ISO 13485
- CFS: Consular legalization of the original (in case CFS has not yet legalized, report back for instructions from the Ministry of Health)
- Material Safety Data Sheet
- Capture the main label
- User manual in English, translated manual into Vietnamese: sensitivity, accuracy, stability must be clinically proven to be correct.
- COA - Certificate of Analysis
- Specification of final product
- Business registration and business lines.
Note: For normal import, you will need to prepare enough of the above documents to avoid taking time to add many times, but in fact this is an urgent procedure that needs to be resolved urgently during the epidemic period, so there will be Certain adjustments by the Ministry of Health also issued a lot of official documents guiding and adjusting procedures for applying for a license to import covid test kits.
According to Document 1592/BYT-TB-CT dated March 25, 2020 of the Ministry of Health, the fact that when businesses apply for a license to import covid test kits encounter the problem of CFS paper in the exporting country as follows: :
Many cases of covid test kits are licensed for use in emergency by the manufacturer country, so the CFS certificate of free sale has not met the provisions of Article 10 of Decree 69/2018/ND-CP dated 15 May 2018 of the Government and the legal documents in the dossier have not been consularly legalized according to regulations. To ensure that we can have quality products in time to meet the current demand for SARS-CoV-2 testing, the Ministry of Health recommends the following units:
In case CFS products show that the product is circulated in the country of manufacture or the country issuing the CFS, the company is allowed to import a number of samples for evaluation and testing at a quality inspection unit designated by the Ministry of Health . Based on the assessment results of the quality inspection unit and the unit's import application, the Ministry of Health will quickly issue an import license to the importer.
In case the legal documents in the import file have not been consularly legalized: it is requested that the unit with the official dispatch be responsible for the authenticity, commit to the time to provide the consular legalization copy and at the same time must provide provide a link to look up the license or contact the licensing agency to check the authenticity of the documents that have not been consularly legalized. All of the above test kits are checked by the quality control unit of the Ministry of Health before being used to screen, confirm…
According to Official Letter 5414/BYT-TB-CT dated July 8, 2021, the issuance of permits to import covid test kits is done as follows:
– For test kits used with medical equipment: comply with the provisions of Circular 30/2015/TT-BYT dated October 12, 2015 of the Ministry of Health on the import of medical equipment. Import procedures will be done on the national Single Window portal.
– For independent use test kits: the composition of the import dossier is specified in the Circular 47/2010/TT-BYT dated December 29, 2010 of the Ministry of Health guiding the export and import of drugs and drugs. packaging in direct contact with the drug, in vitro diagnostic biologicals. Import procedures are carried out online on the public service portal of the Ministry of Health.
Some notes and instructions in making an application for a license to import covid test kits are guided in the official dispatch No. 5650/BYT-TB-CT dated July 15, 2021, you should read as:
The granting of import permits for rapid tests for SARS-CoV-2 antigen tests complies with the provisions of Circular 47/2010/TT-BYT dated December 29, 2010 of the Ministry of Health guiding export and import activities. Import of drugs and packaging in direct contact with the drug.
- The composition of the import dossier is specified in Article 11.
- Legal documents in the dossier specified in Clause 11 Article 4.
- The making of orders, the language and form of the application as specified in Article 5.
Regulations on some profile components for import rapid test antigen SARS-CoV-2:
-The Certificate of Free Sale is stipulated in Law on Foreign Trade Management (Article 36) and Decree 69/2018/ND-CP dated 15/5/2018 stipulates details a number of Articles of the Law on Foreign Trade Management (Article 10).
- Label and instructions for use according to the provisions of Circular 06/2016/TT-BYT dated 08/3/2016 stipulating labelling of drugs part diagnostic products (Clause 2 Article 7 and Article 16).
Import procedures are done online on the Public Service Portal of the Ministry of Health (https://dichvucong.moh.gov.vn)
II, Customs procedures for importing covid test kits
Regarding customs procedures, just like import procedures for other medical equipment, you need an invoice, packing list, catalog, medical classification, import license, customs declaration, bill of lading, ...
For a normal covid test kit, the classification of medical equipment will be class C and an import license is required when doing customs procedures.
In fact, when we went through customs procedures to import the covid test kit, the customs officers also gave priority to this shipment. Your profile just needs to be correct, it will be cleared to pick up goods very quickly.
To find out more detailed information about the procedure to import covid test kits or need a service to apply for a license to import covid test kits from Korea, USA, France, Japan...
Do not hesitate to contact us via our phone number. Hotline: 0973.266.672 (Mr Thang) for advice.
See more:
- Service of applying for a license from the Ministry of Health
- Procedures for importing medical equipment
- Procedures for importing medical masks and masks