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VietTakara is a manufacturer of masks and equipment to produce masks with the best price and quality in Vietnam.

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 Conditions and Procedures for the Production of Medical Masks

Conditions and Procedures for the Production of Medical Masks

In the context of the Covid-19 epidemic is taking place on a global scale, the demand for masks, especially medical masks, antibacterial masks, protective cloth masks, not only in the country but also across the continents has increased dramatically. Because of that, many individuals, organizations and businesses are looking to invest in the production of these essential items.

Medical masks in particular and medical supplies and equipment in general are conditional production lines. Therefore, it is necessary to meet the general standards and regulations of the specific industry to proceed with production and consumption. In the context of the current epidemic, human health issues need special attention. Deploying the production of medical masks, production facilities must meet the following conditions: personnel, equipment, storage and preservation, and certificates of products and goods....

NS production conditions for medical masks This particular case is guided by the specific provisions of Decree 36/ND-CP as follows:

Conditions for the production of medical masks for businesses

1. Conditions on personnel of the medical equipment manufacturing facility

Conditions of professional person in charge:

  • Having a college degree in medical equipment engineering or higher or a university degree in engineering or medicine or pharmacy or higher;
  • Having worked directly in technical medical equipment at medical equipment establishments from 24 months or more
  • Work full-time in a manufacturing facility. The assignment and appointment of the person in charge of the expertise of the production facility must be made in writing.
  • Having a team of employees who can meet the production requirements for the type of medical equipment that the facility produces.

2. Conditions on facilities, equipment and quality control of medical equipment manufacturing establishments

  • Having a location, area and production workshop suitable to the requirements of the type of medical equipment that the facility produces.
  • Having equipment and processes for production and quality control in accordance with the requirements of the type of medical equipment that the facility manufactures. In case quality inspection equipment is not available, a contract must be signed with a qualified quality inspection facility to check the quality of the medical equipment that the facility manufactures.

Having a preserved warehouse meeting the following minimum conditions:

  • Having an area suitable to the type and quantity of preserved medical equipment;
  • Ensure ventilation, dry, clean, not near sources of pollution;
  • Meet other storage requirements of the medical device according to the instructions for use.

Having a means of transporting medical equipment from the production facility to the place of delivery suitable to the type of medical equipment that the establishment manufactures.

Apply the quality management system as prescribed in Clause 1, Article 68 of Decree 36/ND-CP.

 In case the establishment does not have a warehouse and means of transporting medical equipment, it must have a contract with the establishment meeting the requirements for storing and transporting medical equipment as prescribed.

3.Product certificates for production and circulation

4. Obtained the certificate of conformity for textiles and garments for cloth masks according to QCVN 01: 2017/BTC

Mask products must be certified by units licensed by the Ministry of Trade to assess and certify conformity for masks and woven or non-woven fabrics according to National Technical Regulation QCVN 01: 2017/BCT

  1. Announcement of product conformity at the Department of Industry and Trade of the province or city

After obtaining the Certificate of conformity according to QCVN 01: 2017/BCT, the production facility must submit a dossier to the local Department of Industry and Trade for local recognition procedures. Procedures and dossiers announced at the Department of Industry and Trade are based on the provisions of the Law on Product Quality in 2017 and Circular 28/2012/TT-BKHC

    2. Affix the conformity mark on product labels for circulation

    3. Temporary features and techniques for anti-droplet, antibacterial cloth masks

Anti-respiratory, antibacterial cloth masks need to meet the standards and techniques according to the instructions of the Ministry of Health in Decision No. 870/BYT dated March 12, 2020.

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