The COVID-19 pandemic highlighted the potential of the Indian medical devices manufacturing sector. During the pandemic, India manufactured and globally distributed medical devices, such as PPE kits, PCR kits, thermometers, and N-95 masks. India’s transformation in domestic PPE manufacturing capacity from pre COVID-19 to post COVID-19 era needs special mention. From not manufacturing personal protective equipment, India went onto to manufacture approximately 4 lakh PPE products per day. India is a self-sufficient manufacturer as well as exporter of PPE. Owing to easy access to raw materials and low production costs, manufacturing PPE in India has become a flourishing industry. PPE products in India are considered medical devices. Hence, CDSCO registration for PPE will be required. Manufacturers planning to tap into the potential of the Indian PPE manufacturing industry need to comply with CDSCO guidelines.

What is personal protective equipment?

Personal protective equipment (PPE) is used to minimize or prevent exposure to biological, chemical, radiological, electrical, and mechanical hazards. In the healthcare sector, PPE protects healthcare professionals from biological agents and radiation. PPE protects from potential transmission caused by person-to-person contact, droplet spread, airborne transmission, and contaminated objects. Some examples of PPE are gowns, gloves, shoe covers, masks, respirators, face shields, head covers, and goggles. In certain countries PPE is considered a medical device and is regulated by the relevant medical device guidelines.

Manufacturing personal protective equipment in India

Prior to implementation of COVID-19 regulations and lockdown, India was import dependent for PPE. Previously, India did not focus on domestically manufacturing personal protective equipment. Gauging the crisis situation, India rose to the occasion. The government started manufacturing personal protective equipment in India instead of importing it. The number of domestically manufactured PPE products in India was zero prior to the COVID-19 onset. By strategically utilizing resources, India went onto become the 2^nd largest PPE manufacturer in the world within 60 days. Not only was the domestic demand for PPE products in India met but also India started exporting them. Industries focusing on manufacturing personal protective equipment in India witnessed a 56 times growth.

Post COVID-19 onset, manufacturing personal protective equipment in India has considerably increased. India’s ability to domestically manufacture PPE products has come under the spotlight, owing to the role India played in the global battle against the COVID-19 pandemic. PPE products play a vital role in protecting their users from getting infected. Hence, they will continue to be in demand worldwide. Establishing a proper supply chain for PPE products will be crucial for protecting healthcare workers. Hence, industries focusing on manufacturing PPE products in India have a bright future. They will be able to cater to Indian demands as well as supply PPE products globally. As per Indian regulatory guidelines, PPE is considered a medical device. Thus, manufacturers need to abide by regulatory guidelines and requirements for PPE products in India. CDSCO registration for PPE products is required to market them in India

CDSCO registration for PPE products in India

The global PPE market is expected to reach USD 92.5 billion in the near future. Easy access to raw materials and low production costs are some of the advantages of manufacturing personal protective equipment in India. Indian PPE manufacturers can be global leaders in this sector. Indian regulatory guidelines ensure high quality and effective PPE are manufactured in India.

PPE products in India are regulated by the CDSCO under the purview of Medical Devices Rules, 2017. The CDSCO recommends PPE manufacturers to be ISO 13485 certified. On September 2023, the CDSCO stated that a valid medical device license will be required to manufacture, import, sell, or distribute PPE in India. CDSCO registration for PPE ensures the quality, safety, and efficacy of the products are regulated. Hence, manufacturing personal protective equipment in India will require CDSCO registration. The CDSCO license for PPE will remain valid indefinitely as long as regulatory compliance is ensured. Additionally, a license retention fee needs to be paid every 5 years.

CDSCO classification for PPE products

The CDSCO classification system, based on risk level and intended use, helps simplify the medical device registration process in India. For ease of registering PPE products in India, CDSCO has categorised them into medical device classes. As per CDSCO guidelines, PPE products currently belong to mainly Class A and B.

• Class A: Non-latex medical examination glove, Latex medical examination glove, Chemotherapy spill clean-up kit, Medical/Cadaver body bags, Surgical gown (Non-Sterile), Isolation Gown (Non-Sterile), Patient gown, Surgical helmet, Surgical cap, Face shield, Radiation protection mitten and goggles, Radiation face protector, etc.
• Class B: Isolation gown (Sterile), Surgical drape and drape accessories, Latex and non-latex surgical glove, Biosanitizer for medical devices, Protective clothing, Gloves, Face shields, Helmets, Goggles, Facemasks, etc.

The aforementioned list only presents some examples of PPE belonging to various CDSCO classes. The complete CDSCO PPE class list (approximately 32 PPE products) can be accessed here. The PPE manufacturers can register their product based on the specific guidelines for their product’s CDSCO class.

Licensing authority and applicable form for CDSCO registration for PPE

Currently, most PPE products have been classified as CDSCO Class A or B medical devices. Hence, State Licensing Authority (SLA) will be the responsible body for CDSCO registration for PPE. As per Class A and B medical device guidelines, MD 5 License will be required for manufacturing personal protective equipment.

Supporting documents for registering PPE with CDSCO

In order to apply for CDSCO registration for PPE, certain supporting documents will be required along with the application form. The following is an overview of some of the documents required for registering PPE products in India with the CDSCO:

• Documents proving legal ownership of the PPE manufacturing facility.
• Building layout presenting a detailed drawing of the PPE manufacturing facility
• Organization identity proof
• Documents proving competent, qualified, and experienced staff will manufacture and test the products.
• Document supporting compliance with the applicable environmental regulatory requirements.
• Plant master file
• Device master file
• Audit reports
• ISO 13485 certificate demonstrating the manufacturing facility meets international standard for quality management systems.
• Certificate of Analysis of 3 Consecutive Batches

For a detailed list of documents required for CDSCO registration for PPE and document preparation support, feel free to get in touch with us.

How to obtain CDSCO registration for PPE products in India?

To enter the PPE manufacturing business in India, you need a CDSCO registration. To obtain CDSCO registration for PPE, you need to apply using the correct form and prepare supporting documents. Application has to be done via the designated online portal. Additionally, if any queries are raised, they need to be responded to. Hence, the application process for CDSCO registration for PPE is lengthy and cumbersome with multiple steps. We at Pharmadocx Consultants can help you easily navigate through the process and secure your CDSCO license. With an in-depth understanding of the CDSCO regulations, the Pharmadocx Consultants team can be your trusted ally. Our service includes and is not limited to document preparation, license application, mock audit, query response, and license procurement. We leverage our expertise and industry knowledge to help medical device manufacturers obtain medical device manufacturing, test, and import license. We provide customized support and guidance based on your needs.

The first step for entering a medical device business in India is obtaining a CDSCO license. Let us deal with the process of CDSCO registration for PPE so that you can focus on establishing your business. Call/Whatsapp us at 9996859227 or drop an email at [email protected] and let us help you obtain your CDSCO PPE registration.