Personal Protective Equipment Licensing – Covid 19
These days the health and safety of citizens are absolute priorities, and it is vitally important that the population is prepared with equipment that is essential in preventing Coronavirus. A window of opportunity has therefore opened up for many companies to invest in the manufacture of products and equipment needed to combat the new reality. In this sense, it is important to comply with the legal obligations and requirements for placing products on the Portuguese market.
There is a transversal legal basis for all these products and equipment, however, there are some specific procedures and requirements that were exceptionally simplified during the COVID-19 pandemic and with the entry into force of the Decree-Law No. 14-E/2020, of April 13, for placing these products on the national market.
Considering the characteristics and variety of items that can be placed on the market, the following information should be taken into account:
Medical Devices or Personal Protective Equipment
CAE required for the activity:
- Manufacturing of surgical masks falls under subclass CAE-Rev.3 – 13920;
- Manufacturing of gowns, boot covers, bonnets falls under subclass CAERev.3 – 14120;
- Manufacture of protective eyewear falls under subclass CAE-Rev.3 – 32501;
- Manufacturing of full protective suits, scallops falls under subclass CAE-Rev.3 – 32994;
- The manufacture of gloves falls under subclasses CAE-Rev.3 – 14190 (for gloves of textile materials), 22192 (rubber gloves), 22292 (plastic gloves);
- Manufacturing of ventilators for medical use falls under subclass CAE-Rev.3 – 32502.
If you intend to manufacture any of the above-mentioned items, you must license your company to carry out manufacturing activity (industrial activity), regulated by the Responsible Industry System (SIR), and this request will result in obtaining the Industrial Licence.
In addition, you must comply with the safety and performance provisions established by INFARMED, I.P for medical devices or ASAE for personal protective equipment with specific procedures for each case.
After the date of notification, the manufacturer will have a maximum period of 6 months, to decide whether to place on the market and start the necessary procedures for the conformity assessment of products under the Union harmonisation legislation, Regulation (EU) 2016/425, in this case if it intends to have the CE certification.
Community masks or masks for social use
CAE required for the activity:
- Manufacturing of community masks falls under subclass CAE-Rev.3 – 13920.
Community masks or social masks are considered to be a textile article, single-use or reusable. These masks are not intended for health professionals or patients.
The manufacturing process is regulated by ASAE. Manufacturers must license their company for the exercise of manufacturing activity (industrial activity) previously, regulated by the Responsible Industry System (SIR).
After obtaining the Industrial License and before placing the product on the market, ASAE must be notified of the manufacturing activity by email.
Visors
Visors are not considered personal protective equipment, they provide protection against the projection of solid and liquid particles, but do not allow respiratory protection against biological agents. In this sense, they are useful in terms of preventing the risk of exposure.
The manufacturing process is regulated by ASAE. Prior to placing the product on the market, manufacturers must notify the ASAE about the manufacturing activity by email.
After the date of notification to ASAE, the manufacturer will have a maximum period of 6 months to decide whether to place on the market and must prove to ASAE that it has initiated the necessary procedures for assessing product conformity under the terms of the European Union harmonisation legislation, Regulation (EU) 2016/425.ro
Biocides
CAE required for the activity:
- Manufacturing of ethyl alcohol falls under subclass CAE-Rev.3 – 20143;
- Manufacturing of alcohol gel (considered disinfectants for human use), if considered pharmaceutical preparation falls under subclass CAE-Rev.3 – 21202, if not considered pharmaceutical preparation falls under subclass CAE-Rev.3- 20200.
Biocides type 1 are alcohol based preparations which may contain other ingredients as biocidal active substances and are developed to kill microorganisms.
Companies who have never placed products on the Portuguese market must first confirm the applicable procedure if the products contain Active Substances approved at European level or Active Substances not approved at European level.
In both cases they must send the notification and necessary documentation to the national competent authority, DGS or DGAV.
Notifications of biocidal products that comply with the requirements will be valid for a period of 180 days from the day following the submission of the notification to the DGS or after receipt of the electronic message from the DGAV.
Likewise, they are subject to the exercise of industrial activity regulated by the Responsible Industry System (SIR).
Non-compliance with legal obligations, namely the commencement of operation of a type 3 establishment that does not comply with all the legal requirements in force applicable to industrial activity, is punishable by a fine. In accordance with Decree-Law 169/2012 of 1 August, as amended by the Annex to Decree-Law 73/2015 of 11 May and Rectification Declaration 29/2015 of 15 June, this administrative offence is punishable by a fine of between € 2500 and € 44000.
Konceptness is available to clarify any doubts and support any project that you decide to undertake, following the licensing process at the different stages with all the responsible entities. The Future is now and Konceptness can help.
