Conditions of business for some of the necessary medical equipment goods

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Conditions of business for some of the necessary medical equipment goods

Covid-19 disease had been happening for months now, big affected business activities in most of the countries. Whereby, the goods are soaring about consume that are: medical mask, medical gloves, breathing machine, hand wash… Thus, there were a lot of enterprises wishing business above mention goods. However, the legal issue relating to conditions of business those goods also were large difficult with them.

In business activities, there are some differences from conditions of product, import-export, distribution goods for enterprises. This article focuses to explain Conditions of distribution, import and export of four main goods, those are: (i) medical mask, (ii) medical gloves, (iii) breathing machine, (vi) hand wash.

1| Conditions so that goods being medical masks, medical gloves, breathing machine, medical hand wash are allowed to distribution business

According to regulations of law at Clause 1 Article 1 Decree 169/2018/NĐ-CP, above mention goods are medical equipment (a special case of hand washes are announced the product of cosmetic will be analyzed after in this article). However, specialized law doesn’t have individual conditions for enterprises implementing the contribution above mention goods. Whereby, medical masks, medical gloves, medical hand washes are medical equipment having a low level of potential risk associated with technical design and production of medical devices so they are usually classified as group A (accordance to Article 4 Decree 169/2018/NĐ-CP). Particularly for ventilator cases, depending on the technical design and manufacture of the machine, the ventilator may be classified to group A medical equipment or Group B, C, D. Thus, in the case of ventilator products that are classified into the group B, C, D medical equipment, please see more content in section 4 below of this article.

Therefore, in order to business medical equipment, enterprises need to fully implement registry business procedures for distribution activities of goods in order to distribution: medical masks, medical gloves, breathing machines (group A), medical hand washes.

Additionally, Enterprises need to sure that products of medical masks, medical gloves, ventilators (group A), medical hand sanitizers must comply with the following conditions:

  • Have been issued still valid circulation number;
  • Have a label or supplementary secondary label with all information required by law;
  • Have information on usage instructions in Vietnamese;
  • Have technical documents for repair and maintenance, and information about the warranty facility, business conditions and the warranty period for ventilators.

2| Import, export medical masks, medical gloves, breathing machines (group A), medical hand washes

For importing, exporting medical masks, medical gloves, breathing machines, medical hand washes, enterprises implementing the import-export have to meet conditions accordance to regulations of law on import and export. Moreover, enterprises also have to responsible for ensuring the quality of goods imported, exported.

In order to implement importing medical masks, medical gloves, breathing machines, medical hand washes, enterprises have to meet conditions, following:

  • Being the owner of the circulation number / or having a document of the authorization of the circulating number owner (The owner of the circulation number, when authorizing the enterprise to import medical equipment, must send a written authorization to the issuing authority and the customs office);
  • Having warehouses and means of transport meeting the requirements prescribed in Clause 2, Article 37 of Decree 169/2018 / ND-CP / or having contracts with establishments capable of preserving and transporting medical equipment.

The above mention goods items having circulation numbers in Vietnam are exported or imported according to demand, don’t have the limitation of quantities, and do not need approval by the Ministry of Health.

However, currently, in order to cope with Covid-19 disease, Vietnam had policies to particularly guide in distribution, import-export activities of those necessary goods.

For the goods being medical masks, the Government has just issued Resolution 20/NQ-CP dated 28th February 2020 on applying the regime of issuing import licenses for medical marks in the Covid-19 disease period. According to regulations of Government, at this time, the Ministry of Health will grant import licenses for medical marks. Moreover, enterprises are only allowed to export with the international assistance, support goals implemented by Government (maximum is 25% quantity allowed to export, and 75% quantity is used for coping with domestic Covid-19 disease). However, this regulation doesn’t include export activities of processing enterprises had been granted investment certificates or processing enterprises having machined for foreign businessman, having signed contract by 1st March 2020. That means enterprises have not granted investment certificates or signed contracts after the date according to regulations, aren’t allowed to export medical masks because of commerce goals. Particularly, the Ministry of Health has issued Decision 868 / QD-BYT stipulates the issuance of export licenses for medical masks in the stage of COVID-19 epidemic prevention and control. The Ministry of Health has set standards for export masks and guidelines for granting export permits for this item.

However, at the end of April, the epidemic situation in Vietnam began to be overcome. Therefore, the previous restrictive policies were gradually restored. Accordingly, on 29th April 2020, the Government has just issued Resolution No. 60 / NQ-CP on the export of medical masks in the stage of COVID-19 prevention and control. In this resolution, there is no need to continue applying the export license application regime for medical masks in the coming time.

3| Some notes for dry hand sanitizer

Department of Environmental Health Management – Ministry of Health has issued Official Letter No. 205 / MT-SKHC requesting “withdrawing the registration number for products belonging to the product group sterilizing hand that don’t use water, are used in houseware”. Previously, these preparations had been received dossiers of announcing the applicable standards of cosmetics or medical equipment by the Hanoi Health Department.

However, the Ministry of Health then issued a speeding document No. 747 / BYT-TB-CT to all Departments of Health of provinces and cities requesting “not to receive new dossiers and to revoke the cards to be announced later on for the ‘group sterilizing hand that don’t use water, use in households’ that has been announced a class A medical device”. Therefore, the dry hand wash that has been declared as a Class A medical device and been clearly instructed by the Ministry of Health, must be revoked. This has caused businesses to circulate, distribute, import-export dry hand wash and even state agencies have many problems that need to be guided.

According to the Agreement on ASEAN Harmonized System in Cosmetic Management of which Vietnam is a member, Article 2 of the ASEAN Cosmetic Decree has a very clear definition of cosmetics: “A “Cosmetic product” is any substance or preparation used in contact with parts of the outside body such as hair, nails, feet, lips and external genitalia or contact with teeth and mouth, for the sole purpose or primarily of cleaning …”. Additionally, in Clause 1, Article 2 of Circular 06/2011 / TT also defines the cosmetic product as follows: “Cosmetic product is a substance or a preparation used to contact the parts of outside the human body like nails, toenails, lips … that the main purpose is to clean.” Moreover, the Drug Administration of Vietnam has issued Official Letter 1609 / QLD-MP, which also instructs products that are intended to be used for disinfection, disinfection, and antibacterial purposes, which are only acceptable that is suitable with the cosmetic product features if that function is announced as the second function of the product. Therefore, dry hand wash has the main purpose of cleaning hands, and the second use is antibacterial, so it can be considered a cosmetic product.

Accordingly, antibacterial dry hand wash is granted as cosmetics, until the present time, the Ministry of Health has not provided any guidance opinions, so it does not only make embarrassing for businesses, but also the Department of Health of provinces and cities being afraid to grant or revoke this item.

The business of hand wash of enterprises, in case of license revoked, faces many difficulties. Whether or not these products are subject to recall and are lawful when the business continues to sell the item. Dry hand wash is an essential item for people, the Ministry of Health needs specific instructions for businesses as well as provincial Health Departments in order to implement and avoid bewildering in this item business.

4| Notes on breathing apparatus are classified B, C, D

Based on the technical design and production of the ventilator, the business needs to conduct a classification of medical devices to determine the type of medical device. The classification of medical equipment is carried out by organizations that have the function of classification of medical equipment.

Regarding breathing machines, which are classified in groups B, C, and D for distribution, import-export, enterprises should pay attention to a number of following regulations in addition to the regulations on business lines. and the marketing authorization of the product as stated above.

Firstly, the conditions of medical equipment trading establishments are in categories B, C and D

  • Having a qualified technical staff to carry out the installation and use instruction in accordance with the type of medical equipment purchased and sold by the facility, including at least 01 qualified technical staff college degree in engineering or medicine, pharmacy or technical college in medical equipment or higher or higher degree in which the major is trained in accordance with the type of medical equipment. buying and selling facility.
  • Having a warehouse and transportation to meet the requirements as prescribed. In case there is no storage warehouse or means of transportation, there must be a contract with a competent establishment to preserve and transport the medical equipment.

Secondly, when meeting the above conditions, enterprises must carry out the procedures for announcing the eligibility for purchase and sale of medical equipment of categories B, C and D. The order of announcement is as follows:

  • Step 1: The head of the establishment shall send the dossier of announcement of eligibility for sale and purchase to the Department of Health where the sale and purchase office is located (By post or in person at the Department of Health or online submission via network), including:
  • Written announcement of eligibility to buy and sell medical equipment;
  • Human resource declaration;
  • Documents about storage facilities of medical equipment with certification of establishments announcing eligibility for sale
  • Documents about vehicles transporting medical equipment certified by establishments announcing eligibility for sale
  • Step 2: The Department of Health issues the basis for announcing the Receipt of application for announcement of eligibility for sale upon receipt of a complete, valid application or if the application is invalid, a written response will be issued.
  • Step 3: Department of Health publishes the following information on the web portal:
  • Name and address of the facility trading in medical equipment;
  • Dossier of announcement of eligibility for purchase of medical equipment.
  • Processing time: After 03 working days from the date of receipt of complete and valid file.

However, during the operation process, the trading establishment must re-implement the procedure for announcing the eligibility to purchase and sell if there is a change in personnel, storage, and means of transportation of medical equipment.

If you have any questions or require any additional information, please contact Apolat Legal – An International Law Firm in Viet Nam.

This article is for general information only and is not a substitute for legal advice.