Mandatory CDSCO License for PPE (Personal Protective Equipment) Products in India
Personal Protective Equipment (PPE), constituting a diverse array of specialized gear designed to shield individuals from various workplace hazards, is subject to regulatory oversight in India under the Occupational Safety and Health (OSH) Regulations. This category encompasses a wide spectrum of products, ranging from respiratory protective masks and safety gloves to full-body coveralls and face shields, each tailored to address specific safety requirements in different work environments.
As of September 2023, the Central Drugs Standard Control Organization (CDSCO) mandates the possession of a valid Medical Device License for any entity involved in the manufacturing, importation, sale, or distribution of Personal Protective Equipment (PPE) within India.
Licensing authorities for Personal Protective Equipment (PPE) in India
The Central Drugs Standard Control Organization (CDSCO) ) is the licensing authority for Class C and Class D Personal Protective Equipment (PPE) and the State Licensing Authority is the licensing authority for Class A and Class B Personal Protective Equipment (PPE) in India.
List of “Class A” Personal Protective Equipment (PPE)
- Garment, Protective for Incontinence
- Face shield
- Radiation protection gloves
- Partial hand radiation protector
- Radiation protection apron
- Radiation protection mitten
- Radiation protection goggles
- Radiation face protector
- Operator radiation protection spectacles
- Gonadal radiation protector
- Radiation protection blanket
- Radiation protection collar
- Radiation protection cap
- Mobile radiation protection barrier
- 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
- Professional Examination Gown
- Surgical Helmet
- Surgical Cap
List of “Class B” Personal Protective Equipment (PPE)
- Biosanitizer for Medical devices
- Latex surgical glove
- Non-latex surgical glove
- Isolation Gown) ( Sterile)
- Personal Protective Equipment
- Surgical Drape & Drape Accessories
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Personal Protective Equipment (PPE) Licensing Requirement:
- To manufacture Class A and Class B Personal Protective Equipment (PPE) in India, you must obtain the MD 5 License from the State Licensing Authority.
- To manufacture Class C Personal Protective Equipment (PPE) in India, you must obtain the MD 9 License from the Central Drugs Standard Control Organization (CDSCO).
- To import Personal Protective Equipment (PPE) into India, you must obtain the MD 15 Import License from the CDSCO.
Requirements for CDSCO License for PPE (Personal Protective Equipment) Products in India
- Class A and Class B devices: MD 5 License from the State Licensing Authority
- Class C devices: MD 9 License from the CDSCO
- Import: MD 15 Import License from the CDSCO
License Fee for Personal Protective Equipment (PPE) in India
- Class A or Class B: ₹ 5,000/- for manufacturing license, ₹ 500/- for each distinct device.
- Class C or Class D: ₹ 50,000/- for manufacturing license, ₹ 1,000/- for each distinct device.
Validity of CDSCO License for PPE (Personal Protective Equipment) Products
- Personal Protective Equipment (PPE) licenses are valid indefinitely, as long as the retention fee is paid every 5 years.
How to Apply Online for Personal Protective Equipment (PPE) Manufacturing or Import License in India
- Step 1: Enroll your organization on CDSCO’s SUGAM Portal.
- Step 2: Fill in the respective applications and submit them through CDSCO’s online SUGAM Portal.
- Step 3: Upload the necessary documents and make the required payment.
- Step 4: Your application will be scrutinized by the CDSCO Team. If it meets the requirements, it will proceed to a quality management system compliance audit.
- Step 5: The Team will conduct an audit at your manufacturing premises. If any Non-Conformance (NC) is identified, you will be required to submit an NC closure report.
- Step 6: Once all the conditions are met, CDSCO will grant the license.
Deadline for Obtaining CDSCO License for PPE (Personal Protective Equipment) Products in India
The deadline for obtaining CDSCO License for PPE (Personal Protective Equipment) Products in India is October 1, 2022 for Class A and Class B devices, and September 30, 2023 for Class C and Class D devices.
List of Documents for Obtaining an Personal Protective Equipment (PPE) Manufacturing Licenses in India
- Organization identity proof: This could be the Memorandum of Association, List of Directors or Partners, UDYAM Aadhar, or PAN card.
- Sale Deed / Rent Deed of the Premises: This document proves that you have legal ownership of the premises where you will be manufacturing the medical devices.
- Plant or Site Master File: This file contains information about the layout of your manufacturing facility, as well as the equipment and processes you will be using.
- Building Layout with Dimension: This is a detailed drawing of your manufacturing facility, showing the dimensions of each room and the location of all equipment.
- ISO 13485 Certificate and Previous Audit Reports: This certificate shows that your manufacturing facility meets international standards for quality management systems.
- Competent Technical Staff for Manufacturing and Testing of Devices: You must have a team of qualified and experienced staff who can manufacture and test your medical devices.
- Device Master File: This file contains detailed information about each medical device you will be manufacturing, including its design, manufacturing process, and testing procedures.
- Test License, if any: If you need a license to test your medical devices, you must obtain it before you can start manufacturing them.
- Compliance with the environmental requirements: You must comply with all applicable environmental regulations, such as those related to cleanrooms for manufacturing the devices.
- Certificate of Analysis of 3 Consecutive Batches: This certificate shows that the first 3 batches of medical devices you manufactured meet the required quality standards.
