Here you can know about CDSCO License for Personal Protective Equipment in India, the Personal Protective Equipment (PPE), constituting a diverse array of specialized gear created to act as a shield for individuals from various workplace hazards, is subjected to regulatory oversight under the Occupational Safety and Health (OSH) Regulations in India. This category enclosed a broad spectrum of products, ranging from safety gloves and respiratory protective masks up to full-body coveralls and face shields, each tailored to address particular safety requirements in various work environments.

As of September 2023, any entity involved in the manufacturing, importation, sale, or distribution of Personal Protective Equipment (PPE) within India must have a valid CDSCO License For Personal Protective Equipment In India and it is mandated by the Central Drugs Standard Control Organization (CDSCO).

Licensing Authorities For To Get CDSCO License For Personal Protective Equipment In India

Licensing Authorities For CDSCO license for Personal Protective Equipment are followed by:-

• The responsible licensing authority for Class C and Class D Personal Protective Equipment:  The Central Drugs Standard Control Organization (CDSCO).
• The responsible licensing authority for Class A and Class B Personal Protective Equipment: The State Licensing Authority in India.

List Of Class A Personal Protective Equipments (PPE) Are Followed By

• 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 Equipments (PPE) Are Followed By

• Biosanitizer for Medical devices
• Latex surgical glove
• Non-latex surgical glove

• Isolation Gown) ( Sterile)
• Personal Protective Equipment
• Surgical Drape & Drape Accessories

Requirement For CDSCO License For Personal Protective Equipment In India:

• You should get the MD 5 License from the State Licensing Authority to produce Class A and Class B Personal Protective Equipment (PPE) in India.
• You should get the MD 9 License from the Central Drugs Standard Control Organization (CDSCO) to manufacture Class C Personal Protective Equipment (PPE) in India.
• You should the MD 15 Import License from the CDSCO to import Personal Protective Equipment (PPE) into India.

Required Form For CDSCO License For Personal Protective Equipment In India

• Form MD 5 is a License obtained from the State Licensing Authority for Class A and Class B devices
• Form MD 9 is a License obtained from the CDSCO for Class C devices
• Form MD 15 is a Import License obtained from the CDSCO for Import devices

Cost Of CDSCO License For Personal Protective Equipment In India

A manufacturing license costs ₹ 5,000/- only for Class A or Class B and ₹ 500/- for each distinct device. A manufacturing license costs ₹ 50,000/- only for Class C or Class D and ₹ 1,000/- for each distinct device

Validity And Retention Of CDSCO License For Personal Protective Equipment In India

The manufacturing Licenses of Personal Protective Equipments (PPE) are valid indefinitely, the renewal fee must paid for every 5 years.

Procedure To Apply Online For CDSCO License For Personal Protective Equipment In India

• Step 1: You must enroll in your organization on CDSCO’s SUGAM Portal.
• Step 2: The respective application forms must be submitted via CDSCO’s online SUGAM Portal after being filled out. 
• Step 3: All the required documents must be uploaded, and then the payment must be made.
• Step 4: The CDSCO Team will investigate your application. If it satisfies all the requirements of CDSCO, it will proceed to a QMS compliance audit.
• Step 5: The Team will conduct an audit at your manufacturing premises. You must submit an NC closure report if the team identifies any Non-Conformance (NC).
• Step 6: CDSCO will issue the CDSCO license for Personal Protective Equipment after all the requirements are met.

List Of Documents Required For Obtaining An Personal Protective Equipment (PPE) Manufacturing Licenses In India

• Organization identity proof: This is the Memorandum of Association, List of Partners or Directors, UDYAM Aadhar, or PAN card.
• Sale Deed or Rent Deed of the Premises: This deed proves that you have legal ownership of the premises where you will be manufacturing the medical devices.
• Plant or Site Master File: This file composes detail about the layout of your manufacturing facility, as well as the device and processes you will be using.
• Building Layout with Dimension: This is a detailed map of your manufacturing facility, showing each room dimensions and the location of all equipment.
• ISO 13485 Certificate and Previous Audit Reports: This certificate proves that your manufacturing facility meets the requirement international standards for quality management systems.
• Competent Technical Staff for Manufacturing and Devices Testing: You should have a team of experienced and qualified staff who can manufacture and test your medical devices.
• Device Master File: This file encloses detailed information about each medical device you will be manufacturing, including its design, process of manufacturing, and testing procedures.
• Test License, if any: If you require a license to test your medical devices, you must get it before you can start manufacturing them.
• Compliance with the environmental requirements: You should comply with all applicable environmental regulations, such as those relevant to cleanrooms for manufacturing the devices.
• Certificate of Analysis of three Consecutive Batches: This certificate proves that the first 3 batches of medical devices you manufactured meet the required quality standards.