Certification / Registration required for PPE Kits
PPE Kits means Personal Protection Equipments are protective types of equipment like clothes, helmets, goggles, or other garments or equipment designed to protect the equipment user from injury or infection.
Due to the urgency of the COVID-19 (corona virus) outbreak and WHO is providing technical information on appropriate available essential medical devices which are indispensable for treatment centers, community-based units, and other preventive activities, in affected and neighboring countries.
Personal Protective Equipment (PPE) is of vital importance in preventing the spread of the Coronavirus not only in treatment centers but also in other activities, such as sanitation, waste management, and safe burials, and outbreak-related community care.
License required for PPE Kit
➲ DRDO PEE Certification
➲ US FDA
Good Manufacturing Practice (GMP) Is a manufacturing and testing process that helps to ensure a product’s quality. GMP guidelines are not prescriptive instructions for how to manufacture goods. There is a set of general concepts that have to be followed during production. When a company develops its quality system and manufacturing methods, it can be able to satisfy GMP requirements in several ways. It is up to the company to determine the most efficient and effective quality process.
This certification begins with the first step to completing an application process. An authorized individual within the organization obtaining the certification may apply for GMP certification. When manufacturers get audited and conform to the criteria necessary to meet GMP certification requirements then GMP granted in the name of the unit which remains valid for 3 years for the date of certification.
Benefits of GMP certification
➲ Prove management skills of the association in item quality, wellbeing assurance
➲ Encourage members to grow great creation/tasks propensities
➲ Timely recognition of creation and management issues
➲ Better understanding and compliance with essential laws and guidelines
➲ Boost overall reputation and the public image
SITRA stands for South India Textile Research Association, established in 1956 is governed by a council administration consisting of a member representative of the industry, government, and scientists. It sponsored by the ministry of textile of the government of India. It is governed by a council of administration composed of twenty-five members, including representatives from reputed institutions from industry, central and state governments, and scientists.
For selling PPE kit like facemask, apron in the market the manufacturer needs to obtain Unique Certification Code (UCC) from SITRA for this:
The manufacturer needs to courier its sample kit to SITRA for testing along with its product detail and company detail and affidavit form duly stamped and notarized.
Once your product passes the SITRA testing then your company will get a UCC that need to be mentioned on the product while selling the market.
Benefits of SITRA certification
- ➲ The manufacturer can sell its product in markets easily
- ➲ Proof of quality products
- ➲ Proof of tested and qualified product
International Standards Organization (ISO) is an autonomous body setting guidelines for businesses in terms of product quality, health, and performance. An ISO registration improves your company or product reputation There are various forms of ISO certification, such as ISO 9001, ISO 14001, ISO 5001, etc.
Among all the ISO standards, the most common is the ISO 9000 series. ISO 9000 is a compilation of international quality control and assurance standards. The ISO 9000 family of standards such as ISO 9001:2015, ISO 19011:2018, ISO 9000:2015 help companies meet customer service and regulatory criteria and continuously improve. ISO 9000 lays the basis for maintaining a quality management system (QMS).
QMS is a formal system of strategy and implementation strategies, processes, and procedures in an organization's core business areas. ISO 9001:2015 represents the international QMS standard. It is known and embraced internationally and can be adopted by all small, medium and large companies to boost productivity, quality, and income. It also helps to reduce waste, and reduce costs.
Benefits of ISO certification:
➲ It gives an organization a platform where game changers and decision-makers recognize.
➲ Identification and resolution of ongoing problems save precious time and financial help.
➲ Processes are more effective and the system improves.
➲ They offer a firm a competitive advantage that is required during contract tenders
➲ The same resources lead to more profit and profitability.
➲ Customers 'understanding of the company increases tenfold and thus, loyalty increases.
➲ A growing number of companies are opting for ISO 9001 certification because they benefit from the standard by continuously enhancing their results and processes and because it is ab an important requirement for the acquisition of customers.
DRDO PEE certification
DRDO is the Ministry of Defense's R&D department, Govt of India, with a vision to empower India with state-of-the-art weapons systems and a mission to achieve self-reliance on critical defense technology and systems, while equipping our armed forces with state-of-the-art weapons systems and equipment in accordance with the requirements of the three Services.
Today, DRDO is a network of over 50 laboratories dedicated to the development of defense technology covering different disciplines such as aeronautics, armaments, electronics, fighting vehicles, computer systems, instrumentation, missiles, advanced computing and simulation, special materials, naval systems, life sciences, research, information systems, and agriculture.
While the Indian healthcare system is grappling with the increasing demand for personal protective equipment (PPE) in the country, the Union Ministry of Health is facing a major challenge in testing and accrediting a huge quantity of PPE manufactured and imported into the country by only two approved laboratories – South India Textile Research Association (SITRA), Coimbatore & Development Establishment (DRDE), Gwalior.
Personal Protective Equipment (PPEs) are protective devices designed to protect workers' safety by reducing biological agent exposure. Goggles, face-shield, mask, gloves, coverall/gowns (with or without aprons), head cover, and shoe cover are components of PPE.
Getting a certified product or a safe product is every customer's right and wish around the world. CE is a kind of certification mark on health, safety, and environment-related products. It originates in Europe. There is a regulating authority in Europe, called the EEA, that means the European Economic Area. The EEA authenticates the quality of their goods listed there. Items produced within the European Economic Area must receive CE labeling certification obligatorily. Importers need to verify, as well as the manufacturer of the products, that EC labeled products are up to standards. Items shipped to the EEA from other countries may also be labeled with the CE mark as the EEA requirements are a guarantee.
The CE labeling generally refers to products sold in the European Economic Region. It's also found on items sold outside of the EEA.