CDSCO Registration for Surgical Gloves

CDSCO Registration for Surgical Gloves is important, as it is used during surgeries. It helps in ensuring hygiene, reducing infection risk, and both patients and healthcare workers. Due to their Clinical significance, the government of India regulates them under the Medical Device Rules (MDR) 2017 through the Central Drugs Standard Control Organization (CDSCO). If you’re planning to manufacture, import, or distribute surgical gloves in India, obtaining CDSCO registration is not optional. For more details 

What Are Surgical Gloves?

Surgical gloves are sterile disposable gloves worn by surgeons and healthcare professionals during operations and other invasive medical procedures. These gloves help prevent cross-contamination between the surgical team and the patient. They are typically made from materials such as natural rubber latex, nitrile, neoprene, or polyisoprene and come in powdered or powder-free varieties. Because they come into direct contact with open wounds and internal organs, they are considered high-priority medical devices. 

What Is The Classification of Surgical Gloves?

According to the MDR 2017 and the CDSCO risk-based classification:

1. Surgical gloves are Class C medical devices 
2. Class C devices are those with moderate to high risk, requiring stringent quality checks, documentation, and regulatory control. 

This classification means surgical gloves undergo a more strict registration procedure compared to Class A or B devices. 

Is CDSCO Registration Mandatory For Surgical Gloves?

Yes, it is legally mandatory for anyone wishing to manufacture, import, distribute, or sell surgical gloves in India. Operating without a valid CDSCO registration certificate can result in serious legal actions, including product seizures, penalties, or even business consequences.

Who Needs To Apply For CDSCO Registration?

The following entities should obtain CDSCO registration to deal in surgical gloves. 

• Indian Manufacturers
• Importers of Foreign Manufactured Gloves
• Authorized Indian Agents of Foreign Companies 
• Distributors or Repackers (If labeling or repacking is done)

Every type of applicant should follow specific procedures and use specific application forms under the CDSCO guidelines. 

Procedure to Get CDSCO Registration For Surgical Gloves

To know the simple procedure to apply for CDSCO registration for surgical gloves, you must check the points we have mentioned below:

• Check the classification – Confirm that your product is listed as a notified device and comes under CDSCO class C. 
• Create a CDSCO SUGAM Portal Account – First, you have to visit the CDSCO SUGAM portal, then register using your business PAN, Email ID, and Contact details, select the correct category “Importer” or “Manufacturer”. 
• Appoint Authorized Indian Agent (For Importer) – If you are a foreign manufacturer, then you should appoint an Indian Authorized Agent (IAA) who holds a valid wholesale Drug License. 
• Documentation – Gather all the important documents that we have mentioned in the next answer and upload them to the website.
• Application Fee – After these steps, you are required to pay the fee, also it can differ based on the type of applicant (importer vs manufacturer).
• Get the CDSCO Certificate – In the end, if your application is approved, the CDSCO registration certificate will be issued. 

Document Required for CDSCO Surgical Gloves Registration

Check the list of documents needed for the CDSCO surgical gloves registration that is given below:

Specifically for the Importers:

1. Covering Letters
2. Form MD 14
3. Power of Attorney(PoA) by Manufacturers
4. Free Sale Certificate 
5. CE Marking/US FDA Certificate
6. ISO 13485 Certification 
7. Device Master File
8. Plant Master File
9. Product Labels and Packaging Samples 
10. Instructions for Use
11. Declaration of Conformity 
12. Site Master File 

Specifically for the Manufacturers:

1. Covering Letter 
2. Form MD 3 
3. Site Master File 
4. Quality Management System Documents 
5. ISO 13485 Certificate 
6. Details of Manufacturing Facility 
7. DMF and PMF
8. Declaration and Undertaking

What Is The Timeline for Approval?

Generally, the timeline for Class C devices like surgical gloves is 6 to 9 months based on the completeness and updates in the procedure. 

Validity of CDSCO Registration for Surgical Gloves

The registration is valid for 5 years from the date of issuance. If any modification occurs in the product or business structure, it needs to be updated on the portal. 

Renewal Of CDSCO Registration for Surgical Gloves

To get the CDSCO registration renewal done for surgical gloves, check the steps mentioned as follows:

• You are required to apply at least 6 months before expiry 
• Then upload all the documents 
• Provide the proof of continued compliance 
• Now pay the fee for the procedure

What Happens If You Don’t Comply with CDSCO Registration for Surgical Gloves?

If you fail to obtain the CDSCO registration for surgical gloves, it will lead to serious consequences:

1. Seizure of Imported or Manufactured Products
2. Ban on future imports 
3. Heavy fines and criminal liability
4. Loss of trust