Conditions and procedures for producing medical masks, antibacterial masks

In the context of the Covid19 epidemic under investigation on a global scale, the demand for masks especially medical masks antibacterial masks, protective mask cloth masks not only in the country but across the continents spike. Because of that, many individuals and business organizations are looking to learn to invest to produce these essential items.

Medical masks in particular and medical equipment in general are conditional manufacturing industries. It is necessary to meet the general standards and regulations of specific industries in order to conduct production and consumption. In the context of the current epidemic, human health issues need special attention. Implementing the production of medical masks, production facilities must meet the conditions on: Personnel, equipment, storage and certificates of goods products ....

The conditions for exporting this specific medical page, are guided in decree 36/ND-CP as follows:

Conditions for exporting medical masks for enterprises - 19006512

1. Conditions on personnel of medical equipment manufacturers

Conditions of the person in charge of expertise:

• Having a degree from technical college of medical equipment or higher or a degree from a university specialized in engineering or majoring in medicine or pharmacy or higher;
• Have direct time in medical equipment engineering at medical equipment facilities for 24 months or more
• Work full-time at the production facility. The appointment and appointment of professional in-charge of production establishments must be expressed in writing.
• There are staff who meet the production requirements for the type of medical equipment that the facility produces.

2. Conditions on facilities, equipment and quality management of medical equipment production establishments

• There are locations, area and factory in accordance with the requirements of the type of medical equipment that the facility produces.
• There are equipment and production processes, quality inspection in accordance with the requirements of the type of medical equipment that the facility produces. In case there is no quality inspection equipment, there must be a contract with a facility capable of quality inspection to check the quality of medical equipment produced by the manufacturer.

There are treasure trove of museums that meet the following minimum conditions:

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

There are means of transporting medical equipment from the production facility to the place of delivery in accordance with the type of medical equipment that the facility produces.

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

In case the facility does not have a warehouse and means of transporting medical equipment, it must have a contract with the facility to meet the requirements of warehouses and transport medical equipment as prescribed.

3. Product Certificates for production and circulation

4. Achieving textile and garment regulations certification for fabric masks according to QCVN 01: 2017/BTC

Mask products must be certified by units licensed by the Ministry of Commerce to evaluate and cate the regulations for masks and textiles or non-woven fabrics in accordance with national technical regulations QCVN 01: 2017/BCT

1. Announcing product regulations at the Department of Industry and Trade of provinces and cities

After receiving the Certificate of Compliance under QCVN 01: 2017/BCT, the production facility must submit the dossier at the local Department of Industry and Trade for local recognition procedures. Procedures and dossiers published at the Department of Industry and Trade are based on the law on quality of goods products in 2017 and Circular 28/2012/TT-BKHC

2. Attaching a valid label to a product label for circulation

3. Temporary features and techniques for cloth masks resistant to droplets, antibacterial

Cloth masks resistant to respiratory and antibacterial droplets should be counter-standard and technical as guided by the Ministry of Health in Decision No. 870/BYT on March 12, 2020.

The above are the regulations on procedures, production conditions and circulation of medical masks. Organizations and individuals need to study and thoroughly understand the regulations for this special object. If the information is unknown, it is best to go to the Licensing Agencies of the Ministry, Department of Health for advice and assistance. Avoid falling into the case, the product has been produced but has not been circulated, consumed in the market due to still not guaranteed or produced in accordance with the technical standards that the health agency requires.

For any questions about the law or conditions of production of medical masks, please contact the Legal Advice Switchboard 1900.6512 for the most specific advice from DFC's lawyers.

Thank you!
LS. Le Minh Cong