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Margesh Rai
| Updated: 14 Apr, 2020 | Category: CE Certification

Approvals Required to Meet the Requirement of Face Mask and PPE Kit License

Face Mask and PPE kit license

CE Certification has become an essential requirement for products to get sold in the EU. CE Marking states that the manufacturer has assessed the product properly, and there is an interpretation that CE marking meets the requirements of EU safety, health as well as environmental protection. Even if the manufacturing of products has taken place in any part of the world, it must need CE marking before getting available in the market for sale.

How to get CE Certified to meet Face Mask and PPE kit License Requirement?

The manufacturer of the products is the responsible person for assuring conformity with all the requirements. The face mask and PPE kit must meet the needs of applicable EU directives[1]. There is no need to get a license to affix the CE marking to products, however, before going for that, you should-

  • Have detailed knowledge about the EU requirement for your product
  • Ensure that products got manufactured in accordance with relevant EU-requirements
  • Assess whether the product requires testing by a notified body
  • Test your product
  • Analyze whether the product adhere to the technical requirements or not
  • Affix CE Marking and sign an EU declaration of conformity

What are the Prior Requirements of Affixing the CE Marking?

There are bodies like EU manufacturers, distributors of products, and importers who want to sell the product in the EU market are the responsible bodies behind CE marking. As the manufacturer proceeds for the conformity assessment themselves, they won’t be paying any fees from their end. As per the law, evaluation and preparation of the technical file and declaration signing belong to the manufacturer.

  • Before products get placed in the market, Following CE marking and EU directives is a mandatory point to consider.
  • Manufacturers are entitled to assess, which EU directives will be applicable in case of their products.
  • The placement of the products in the market depends upon its compliance with the provisions of all applicable guidelines and instructions, and if the process of conformity assessment has taken place in a secure way.
  • Then, the manufacturer went on signing an EU declaration of conformity EU standards.
  • It affixes the CE marking on the product.
  • In case of need in the directives or management, a notified body looks after the assessment process and also finds ways to set up a production-quality system.
  • The CE marking should be decipherable, noticeable and indelible.

Our keenly priced and practical strategy related to CE Marking of Personal Protective Equipment complying with the Directive meets the demands of small-scale and mid-scale manufacturing entities that export the products to the European Union.

By getting CE certification, commercialization of your medical products that are critical requirements nowadays due to the Coronavirus crisis ravaging the whole world. Those manufacturers who are involved in manufacturing legal, medical devices and kits must take responsibility for managing regulatory compliance and bringing their products under the roof of CE marking, regardless of whether you outsource one or few parts of the products or all the components. Our regulatory experts can help you in getting CE Certification for your face mask and PPE kit and start selling them anywhere in the world.

What is the Validity Period for the CE Certificate?

The validity of the CE certificate issued by notified bodies is limited for three years. For devices that are associated with high risks, the validity period is of one year. Nevertheless, the CE certification status depends on the maintenance of quality system certification.

GMP Certification concerning Face Masks and Medical Devices

The introduction of GMP certification is concerned with natural and pharmaceutical products manufacturing. GMP stands for Good manufacturing practices is a system and a set of guidelines ensuring that your products are safe and correct as their production has taken place as per the quality standards. GMP encompasses all the production aspects beginning from the initial materials, premises and equipment to the staff’s health and hygiene maintenance.

At each step in the process of manufacturing a product, things should be in such a systematic way that getting access to documented proof related to quality maintenance throughout the process becomes readily available. GMP also covers the defects and complaints related to products. In the year 1968, the fact of the adoption of first WHO draft text on GMP came into light. It was in the year 1969 when the World Health Assembly suggested the first version of the scheme of WHO certification on the standard and quality of pharmaceutical products circulating in the market of all the countries.

Around 100 countries have embodied the WHO provisions of GMP into their national medicine laws, and there are several countries who have adopted its regulations and approach in determining their domestic GMP demands. WHO certification scheme is based on the WHO GMP.

Read our article:What is CE Certification? -Know about it in detail

Fundamental Principles Related to GMP Guidelines and GMP Certification

Pharmaceutical and medical device manufacturers should maintain a clean and hygienic area where manufacturing process goes on.

  • Manufacturing processes should be clearly defined as well as controlled.
  • Any changes related to manufacturing processes must go under evaluation.
  • Procedures and instructions should be free from ambiguity and vagueness.
  • Operators have received the training in such a manner that they will be able to carry out and document procedures.

There will be a proper examination and thorough inspection of the complaints about marketed products. The investigation will be in the line of finding the causes of quality defects. The requirement will be of taking appropriate measures in relation to the flaws in products and averting recurrence at any cost.

As the need of the hour is to maintain cleanliness and proper hygienic environment, the GMP Certification is not only limited up to the manufacturing process of the actual product, but also it ensures that quality control of issues of administration like those of record maintaining, qualifications of personnel, sanitation as well as cleanliness along with validation of the process. Companies that hold the GMP certification can say that their manufactured supplements are high in terms of quality and match the standards at the world level.

Acquiring GMP Certification

This certification begins with the first step of completion of an application process. An authorized person has to make an application for GMP certification inside the company seeking the certification. If auditing of a facility gets over and if they are in accordance with the standards required to fulfil GMP certification requirements.

As issued in the name of a registered company, GMP certificate is valid for three years only. This certificate will showcase the certification scope along with the name and the address of the manufacturing place of the company.

FDA Certification

The Food and Drug Administration(FDA Certification) plays a vital role in shielding the U.S from threats such as rapidly spreading infectious diseases, also comprising the recently declared Pandemic, i.e. Coronavirus disease 2019(COVID-19). The Food and Drug Administration is setting its sights to provide time to time direction to give wings to the response efforts to this Pandemic. By issuing this guidance, the FDA is providing a policy to make the general use face masks available for the general public and N95 respirators for health care professionals till the time this Pandemic comes to an end.

This policy will continue to remain in effect only during the time of public health emergency related to COVID-19 as proclaimed by the Health and Human Services department (HHS Department). Also, fencing in any renewals from the secretary end in consonance with section 319(2) of the PHS Act.

Since FDA has ascertained that it’s inappropriate to have prior public participation for this guidance, the implementation of this guidance will happen without prior comment of the public. However, the guidance documentation implementation will come into the picture immediately.

Food and Drug Administration – The Regulatory Body

FDA is the regulatory body that regulates face masks and respirators. These face masks, respirators and other PPE kit must meet the definition of a device under section 201(h) of the FD& C Act, i.e. expanded as Federal Food, Drug, and Cosmetic Act. Usually, face masks come under the radar of this definition when they get intended for a medical need, including for health care professionals use. Those face masks that don’t get considered for medical purpose is not a part of medical devices. FDA regulated face masks, and respirators are as follows-

Device Types under Classification Regulation

21 CFR 878.4040

Mask, surgical under product code FXX

  • Pediatric/child facemask under product code OXZ
  • Accessory, surgical apparel (Face shield) under product code LYU
  • Surgical mask with antiviral/antimicrobial agent under product code OUK
  • Respirator, surgical under product code MSH
  • N95 Respirator with Antiviral/Antimicrobial agent under product code ONT

21 CFR 880.6260

  • N95 Respirator with Antiviral or Antimicrobial agent for general public use in public health medical emergencies under product code ORW

21 CFR 880.6260

  • N95, Respirator for the general public use in public health medical emergencies in product code NZJ

Recommendations by FDA

In the wake of a coronavirus outbreak, the FDA has analyzed and understood that the demand for personal protective equipment (PPE), such as surgical suites, surgical gowns, surgical masks, isolation gowns might surmount the availability of supply to healthcare centres across the world throughout the COVID-19 outbreak.

The conservation strategies for use by healthcare organizations are not limited to use for the patients’ infected with COVID-19 and also it does not enfold N95 respirators. The FDA’s recommendations won’t be replacing procedures and specific controls constructed by the healthcare organizations, CDC Healthcare Infection Control Practices Advisory Committee (HICPAC), the Centers for Disease Control and Prevention (CDC) to extend support in preventing infection and control. These recommendations have nothing to do with hiking up.

  • As per the local, state and federal needs, use FDA-cleared gowns and surgical masks.
  • In place of disposable single-use gowns, bring the use of reusable gowns into the attention.
  • Till the time surgical masks are available in limited numbers, healthcare providers should use the same surgical mask, and they need to remove gloves and gowns. In case of contamination of gowns, masks as well as gloves, they must get replaced.
  • Use only those surgical gowns and masks that match CDC recommendations and matching other set standards.
  • In the hours of reduced supply, look for counterfeit masks and gowns in the market.
  • In case there is no availability of surgical masks and gowns, have a look at the CDC’s considerations for opting guarding clothing used for protection against small organisms present in blood and body fluids.
  • If there is any concern related to visible tears in surgical masks, discard the product immediately.

FDA Approval for Medical Devices

FDA is known for regulating a wide array of products like a drug, food, cosmetics as well as medical devices. There are many set standards of FDA on which it measures the quality of products. The requirements vary from one product category to another. Very often, class 1 and class 2 medical devices do not need approval by the Food and Drug Administration. Class 3 medical devices must have FDA approval for the marketing of products. Class 2 medical devices demand a marketing clearance from the FDA side. FDA registration and device listing are mandatory for all medical device establishments.

Actions under the Wings of FDA

The FDA is joining hands with the surgical masks manufacturers to get access to better knowledge about the supply chain issues related to the COVID-19 outbreak and to ensure that there wouldn’t be any shortage of these products. If there will be new or extra information becomes available, the FDA will keep informing the public, healthcare providers as well as manufacturers.

In case of any suspected adverse events or adverse events, the Food and Drug Administration pushes healthcare providers to report for these events.

IMA Approval

Indian Medical Association is in touch with the National Medical Associations of different countries to share relevant information and create awareness about the best practices at Indian and International level.  Approval of the Indian Medical Association matters a lot, especially in the time of grave medical emergency. Their stamp of approval works for the products, and it’s a sign that the products are health-friendly since they got approved by IMA.

Conclusion

The requirement of PPE kit certification and face masks need to go through the certification of CE, GMP, FDA and approval of IMA. These medical products must follow the guidelines as it is prescribed under the certification and approval processes.

Read our article: How to Get CE Marking Certification in India?

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Margesh Rai

Being a poetry lover, and an avid reader, Margesh is fanatical about legal content writing. After completing graduation in B.Com(H), he decided to follow his passion. Writing impeccable in-depth content about legal and finance-related topics is his biggest forte.

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