Latex and Nitrile Gloves CDSCO Medical Device License (MD5 MD15)

Last updated: February 13, 2023

In order to manufacture and import gloves, you need to get a license from CDSCO. Here you will find answers to various questions on latex and nitrile gloves license requirements.

We will answer the following questions -

What are the various types of gloves as per CDSCO?

CDSCO with its notification date 21st September 2021 under the heading “Personal Protective equipment” has classified gloves into 5 categories with Latex Examination Gloves, Non-latex Examination gloves, Radiation Protection gloves under class A and Latex Surgical Gloves, Non-latex Surgical Gloves under Class B.
Description as per CDSCO Notification is as follows.

What are the requirements to import and manufacture Class A medical gloves?

Pharmadocx consultants can guide you in registration for Import and Manufacture of Latex Examination Gloves, Nitrile Examination gloves, non-latex examination gloves. For registration for Class A products following documents are required.

1. Aadhar Card
2. PAN Card
3. GST Certificate
4. Certificate of incorporation
5. ISO 13485
6. Free Sale Certificate

We at Pharmadocx consultants can guide you in this process for registration of various types of examination gloves. The government fee for the registration of gloves of class A on the online portal is INR 0. Once the registration is completed, A file number is generated which shall be printed on the label of the product being imported. It is important to note that Sterile gloves cannot be imported by the means of registration.

What are the requirements for manufacture of latex & non latex surgical gloves?

In order to manufacture Latex surgical glove (Natural rubber-based glove intended to protect the patient and wearer from cross infection when used in medical or dental surgery) or Non Latex surgical gloves (Synthetic material glove intended to protect the patient and wearer from cross infection when used in medical or dental surgery) or Nitrile surgical gloves (Nitrile based glove intended to protect the patient and wearer from cross infection when used in medical or dental surgery) a license is required on Form MD5. The government fees for the license to manufacture sterile gloves of class B is Rs 5000 (license fee) and Rs 500 (per product).
Prior to grant of this license an audit is conducted of your premises as per the requirements of medical device rules, 2017 & ISO 13485:2016. The checklist for the documents required for application for license to manufacture gloves can be downloaded using the link given below. The entire process from the time of application takes to grant of license takes about 3 months to complete.
Checklist Download Link

What are the requirements for import of latex & non latex surgical gloves?

In order to import Latex surgical glove (Natural rubber-based glove intended to protect the patient and wearer from cross infection when used in medical or dental surgery) or Non Latex surgical gloves (Synthetic material glove intended to protect the patient and wearer from cross infection when used in medical or dental surgery) or Nitrile surgical gloves (Nitrile based glove intended to protect the patient and wearer from cross infection when used in medical or dental surgery) a license is required on Form MD15. The government fees for the license to manufacture sterile gloves of class B is USD 2000$ (license fee) and USD 1000$ (per product).
In case of import audit of the premises is not conducted. The checklist for documents required in order to import latex surgical gloves, non latex surgical gloves, nitirile surgical can be downloaded from the link given below. The entire process from the time of application takes to grant of license to import Latex Surgical gloves, Nitrile Examination gloves takes about 4 months to complete.
Checklist Download Link

What is the government fee for manufacturing license of Class B latex Surgical Gloves, Nitrile Surgical Gloves on MD5?

The government fee for license to manufacture Class B (latex Surgical Gloves, Nitrile Surgical Gloves) or sterile gloves is Rs 5000 for license and Rs 500 Per product.

What is the government fee for import license of Class B latex Surgical Gloves, Nitrile Surgical Gloves on MD15?

The government fee for license to manufacture Class B (latex Surgical Gloves, Nitrile Surgical Gloves) or sterile gloves is Rs 5000 for license and Rs 500 Per product.

What is the government fee for registration for import or manufacture class A (Latex Examination gloves, nitrile examination gloves, non-latex medical examination gloves)

There is no government fee for registration of Latex Examination gloves, nitrile examination gloves, non-latex medical examination gloves of Class A for both manufacturing and import.

We at Pharmadocx Consultants can provide consultation services to firms looking for license to either manufacture or import Latex Examination gloves, Nitrile Examination Glove, Radiation Protection gloves, Latex Surgical Gloves, Nitrile Surgical gloves and all other types of Class A and Class B Gloves. We have been providing consultancy to various firms throughout for over 15 years. We have served over 150 medical device companies in our history. We ensure that the clients face no difficulties or hurdles In the way to manufacture and import any medical device.

You can contact us on 9996859227 or at [email protected] for guidance and consultation on how to manufacture and import gloves or any other medical devices. We will be happy to serve you in your endeavour.