31 May 2020
Licenses Required for Face Mask and PPE Kit

    The outbreak of Novel coronavirus disease (now named COVID-19) was initially noticed from a seafood market in Wuhan city in Hubei Province of China in mid-December, 2019, has spread to more than 185 countries/territories worldwide including India. The causative agent for COVID-19, earlier termed provisionally as novel Coronavirus has been officially named as SARS-CoV-2.

    There is clear evidence of human-to-human transmission of SARS-CoV-2. It is thought to be transmitted mainly through respiratory droplets that get generated when people cough, sneeze, or exhale. Further, SARS-CoV-2 also gets transmitted by direct touch and through contaminated objects or surfaces and then touching their own mouth, nose, or possibly their eyes. The people most at risk of COVID-19 infection are those who are in close contact with a suspect/confirmed COVID-19 patient or who care for such patients i.e. healthcare workers.

    Right now, protective measures include use of protective gears - face mask and Personal Protective Equipments (PPEs) to safeguard the health of workers by minimizing the exposure to a biological agent. And to ensure their quality and protection capacity of PPE Kit and Face Masks following certifications have been made mandatory for manufacturing and supply in EU Market :

    1. CE Marking : CE is an abbreviation of "Conformité Européene" which literally means "European Conformity".

    2. GMP Certification : Good manufacturing practices are guidelines required to be compiled in manufacturing of pharmaceutical products, cosmetics and medical devices.

    3. FDA Certification : Food and Drug Administration is the regulatory body for face masks, respirators and other PPE kit which 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.

    4. ISO 9001 certification : It deals with management as it describes and reviews the procedure and systems for effective and efficient management.

    CE Marking

    CE marking indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area. 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 EU market for sale.

    How to get CE Certification for Face Mask and PPE Kit ?

    There is no need to get a license, however the face mask and PPE kit must fulfill the requirements of relevant European product directives, to affix the CE marking to products. These European product directive are as follows :

      The product must meets all the requirements of the relevant recognized European harmonized performance and safety standards

      Check whether the product needs testing by a notified body, if yes, Test your product

      Product must adhere to the technical requirements

    If above mentioned conditions are fulfilled one can affix CE Marking of his products (CE Marking must be noticeable, decipherable and indelible) and further needs to sign an EU declaration of conformity.

    Validity of CE Certificate

    CE certificate issued by notified bodies is valid for a period of three years. Whereas, in case of devices associated with a high risk certificate is valid for one year. Nevertheless, the status of CE certification majorly depends on the maintenance of quality of products.

    GMP Certification

    GMP (Good manufacturing Practices) is a complete system ensuring that manufacturing of Pharmaceutical products and medical devices are produced and controlled according to quality standards. GMP is designed with the aim to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

    The main risks are:

      Unexpected contamination of products making it unfit for consumption which may lead to health damage or death.

      Incorrect labels on containers and equipment, which could mean that patients receive the wrong medicine.

      Too much active ingredient or insufficient, resulting in ineffective treatment or adverse effects.

    GMP covers all aspects of production and is not limited to the actual product's manufacturing; from the starting materials, premises and equipment to the training and personal hygiene of staff through the quality management system. Companies holding GMP certification are deemed to ensure the highest quality of manufacturing processes and their products match the standards at the world level.

    Process of acquiring GMP Certification :

    An authorized person has to make an application with the basic information of the company for GMP certification. The application get reviewed by the WHO Team and thereafter audit is being conducted for evaluation of existing procedure and policies against the compliance requirement. After correcting issue, if any, the company is granted GMP Certification.

    Validity of GMP Certification :

    Validity of the GMP Certificate is 3 years. The certificate will showcase the certification scope along with the name and the address of the manufacturing place of the company.

    FDA Certification

    Food and Drug Administration, the regulating body in USA plays a critical role in protecting from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to make available timely guidance to support response efforts to this pandemic.

    FDA has issued guidelines to help the availability of general use face masks for the general public and particulate filtering face piece respirators (including N95 respirators) for healthcare personnel (HCP)1 for the duration of the COVID-19 public health emergency.

    Approval for Medical Devices from FDA :

    FDA is known for many set standards of measurement of quality of drug, food, cosmetic and medical devices. The testing requirements and standards vary from one product category to another. Generally class 1 and class 2 medical devices do not need approval by the FDA. Whereas, class 3 medical devices must have FDA approval for the marketing of products. Class 2 medical devices only need to get a marketing clearance from the FDA. However, FDA registration and device listing are mandatory for all medical device establishments.

    ISO 9001 : Quality Management System

    It deals with management as it describes and reviews the procedure and systems for effective and efficient management. This certificate is valid for Manufacturer, trader, importer/exporter of Medical and Non Medical safety masks, Non woven mask, 4 ply mask, 5 ply mask, N95 mask, 6 ply mask, Surgical mask, Healthcare products, Non woven garment, sanitary napkins, shoes cover, drapes and safety gown, gloves and covers, medical apparatus, sanitizers, personal protective equipments (PPE kit) and all related medical and non medical materials and equipments.

    Why LegalEase :

    With the rising possibilities for pharma companies in India brings increasing compliance. With the assistance of an expert by your side, facing and overcoming these compliance procedures will be less complicated. We at LegalEase not only submit and get approvals but also ensure that all the process gets easier and quick.

    Our experts can assist you in getting appropriate certifications and approvals for your PPE kit and facemasks, so that you can supply them anywhere in the world.