CDSCO Registration for Gastroenterological Medical Devices in India

CDSCO Registration for Gastroenterological Medical Devices in India. Gastroenterological medical devices are specialized instruments and equipment designed for the diagnosis, treatment, and management of disorders related to the digestive system, including the oesophagus, stomach, intestines, liver, and pancreas. These devices play a key role in procedures such as endoscopy, colonoscopy, biopsy, and surgical interventions. Given the sensitive nature of gastroenterological treatments, these devices must adhere to stringent regulatory standards to make sure patient safety and efficacy. In India, the Central Drugs Standard Control Organization (CDSCO) is the regulatory authority responsible for the approval and oversight of medical devices, including gastroenterological equipment. Manufacturers and importers must obtain CDSCO registration before marketing these devices in India.
Categories and Classification of Gastroenterological Medical Devices
The CDSCO classifies medical devices into four categories (A, B, C, and D) based on their risk level, with Class A being low-risk and Class D representing high-risk devices. Gastroenterological devices fall under different categories depending on their intended use and potential risk to patients.

Device Type

Risk Class

Examples

Endoscopes (Diagnostic)

Gastroscopes, Colonoscopes

Endoscopic Accessories

A/B

Biopsy Forceps, Snares

Stents (Esophageal, Biliary)

C/D

Self-expandable Metal Stents

Laparoscopic Instruments

B/C

Graspers, Trocars, Clip Appliers

Hemostasis Devices

Hemostatic Clips, Band Ligators

Benefits of CDSCO Registration for Gastroenterological Devices
Obtaining CDSCO registration ensures that gastroenterological devices meet the necessary safety, quality, and performance standards. For healthcare providers, it guarantees access to reliable and effective medical equipment. For patients, it minimizes risks associated with faulty or substandard devices. Additionally, registered devices gain market credibility, facilitating smoother procurement by hospitals and clinics.
How to Obtain CDSCO Registration for Gastroenterological Devices
To apply the CDSCO Registration for Gastroenterological Medical Devices in India, manufacturers and importers must comply with the Medical Device Rules, 2017 under the Drugs and Cosmetics Act, 1940. The Central Drugs Standard Control Organization (CDSCO) is the regulatory authority responsible for granting registration and licenses for medical devices, including Gastroenterological devices such as endoscopes, feeding tubes, biopsy forceps, stents, and capsule endoscopy systems.
Step 1: Determine Device Classification
Identify the risk class (A, B, C, or D) of the gastroenterological device as per the Medical Device Rules (2017).
Step 2: Appoint an Indian Authorized Agent (For Foreign Manufacturers)
Foreign manufacturers must appoint an authorized local representative in India to liaise with CDSCO. Here’s a complete overview on how to appoint an Indian Authorized Agent for foreign manufacturers, particularly in regulatory contexts like CDSCO (Central Drugs Standard Control Organization), BIS (Bureau of Indian Standards), or FSSAI (Food Safety and Standards Authority of India)
An Indian Authorized Agent (IAA) is a legally recognized representative appointed by a foreign manufacturer to act on their behalf in India for regulatory purposes. The agent must be an Indian entity with a valid import-export code and preferably have relevant regulatory approvals or licenses.
Step 3: Compile Required Documents
The essential documents include:

Device master file with technical specifications

Clinical trial data (if applicable for Class C & D devices)

Quality management system certificates (ISO 13485)

Free Sale Certificate (FSC) from the country of origin

Labelling and user manual details

Additional documents are typically required

Cover letter with product details

Device Master File (DMF) / Plant Master File (PMF)

ISO 13485 certification

Free Sale Certificate (for imported devices)

Clinical evaluation report

Product labels and brochures

Undertaking by manufacturer/importer

CE Certificate (if applicable)

Manufacturing license (for domestic manufacturers)

Power of Attorney (if applicable)

Step 4: Submit Application and Pay Fees
The application must be filed via the CDSCO’s online portal along with the requisite fees, which vary based on device class. In case you are facing any issue related to Registration and process, Feet free to contact us on 9988424211 or Email info@ccoffice.in

Device Class

Registration Fee (INR)

Class A & B

50,000

Class C & D

1,00,000

Step 5: CDSCO Evaluation and Approval
Once the application for CDSCO registration is submitted (either for import or manufacture), the next crucial step is evaluation and approval by the Central Drugs Standard Control Organization (CDSCO). This process ensures that only safe, effective, and quality-assured Gastroenterological devices are permitted for sale in India.
Renewal and Validity of CDSCO Registration
The CDSCO registration for medical devices is valid for five years. Manufacturers must apply for renewal at least six months before expiry. The renewal process involves submitting updated documents, including any changes in device specifications or regulatory status.
Top 5 Market Leaders in Gastroenterological Medical Devices in India

Olympus Medical Systems India (Maharashtra) – A global leader in endoscopy and minimally invasive surgical devices.

Fujifilm India (Delhi) – Specializes in advanced endoscopic imaging systems.

Boston Scientific India (Karnataka) – Known for innovative stents and endoscopic surgical tools.

Karl Storz India (Gujarat) – Provides high-quality laparoscopic and endoscopic instruments.

Medtronic India (Telangana) – Offers a wide range of gastroenterological and surgical devices.

FAQs
Q1. What is CDSCO registration for Gastroenterological devices?
Ans. CDSCO registration is a regulatory approval process by the Central Drugs Standard Control Organization that allows manufacturers or importers to legally sell gastroenterological medical devices in India.
Q2. Is CDSCO registration mandatory for all Gastroenterological devices?
Ans. Yes, as per the Medical Device Rules, 2017, registration is mandatory for all Class A, B, C, and D gastroenterology devices notified by CDSCO.
Q3. What types of Gastroenterological devices require registration?
Ans. Devices such as endoscopes, biopsy forceps, stents, feeding tubes, capsule endoscopy systems, and GI catheters require CDSCO registration.
Q4. How are Gastroenterological devices classified in India?
Ans. They are classified based on risk:

Class A (Low risk)

Class B (Low-moderate risk)

Class C (Moderate-high risk)

Class D (High risk)
 Most GI devices fall under Class B to D.

Q5. Who can apply for CDSCO registration?
Ans. Manufacturers (for domestic production) and Authorized Indian Agents (for foreign manufacturers) can apply for registration through the CDSCO’s Sugam portal.
Q6. What documents are required for CDSCO registration?
Ans. Key documents include ISO 13485 certificate, Free Sale Certificate, CE Certificate (if available), Device Master File, Plant Master File, and an undertaking by the applicant.
Q7. What is the fee for obtaining CDSCO registration?
Ans. Fees vary by device class and number of models. For example, Class B import license may cost Rs.1,000 per model, whereas Class D may cost up to Rs.50,000.
Q8. How long does it take to get CDSCO approval?
Ans. Approval time varies by device class:

Class A & B: Around 4–8 weeks

Class C & D: Around 3–6 months (may require clinical evaluation and SEC review)

Q9. What is the validity of the CDSCO registration certificate?
Ans. The CDSCO license is valid for 5 years from the date of issue, subject to compliance with post-market obligations.
Q10. Can I renew my CDSCO registration?
Ans. Yes. Renewal must be applied for at least 6 months before expiry of the existing license by submitting updated documents and paying the renewal fee.

Gastroenterological medical devices are specialized instruments and equipment designed for the diagnosis, treatment, and management of disorders related to the digestive system, including the oesophagus, stomach, intestines, liver, and pancreas. These devices play a key role in procedures such as endoscopy, colonoscopy, biopsy, and surgical interventions. Given the sensitive nature of gastroenterological treatments, these devices must adhere to stringent regulatory standards to make sure patient safety and efficacy. In India, the Central Drugs Standard Control Organization (CDSCO) is the regulatory authority responsible for the approval and oversight of medical devices, including gastroenterological equipment. Manufacturers and importers must obtain CDSCO registration before marketing these devices in India.

Categories and Classification of Gastroenterological Medical Devices

The CDSCO classifies medical devices into four categories (A, B, C, and D) based on their risk level, with Class A being low-risk and Class D representing high-risk devices. Gastroenterological devices fall under different categories depending on their intended use and potential risk to patients.

Device Type	Risk Class	Examples
Endoscopes (Diagnostic)	B	Gastroscopes, Colonoscopes
Endoscopic Accessories	A/B	Biopsy Forceps, Snares
Stents (Esophageal, Biliary)	C/D	Self-expandable Metal Stents
Laparoscopic Instruments	B/C	Graspers, Trocars, Clip Appliers
Hemostasis Devices	C	Hemostatic Clips, Band Ligators

Benefits of CDSCO Registration for Gastroenterological Devices

Obtaining CDSCO registration ensures that gastroenterological devices meet the necessary safety, quality, and performance standards. For healthcare providers, it guarantees access to reliable and effective medical equipment. For patients, it minimizes risks associated with faulty or substandard devices. Additionally, registered devices gain market credibility, facilitating smoother procurement by hospitals and clinics.

How to Obtain CDSCO Registration for Gastroenterological Devices

To apply the CDSCO Registration for Gastroenterological Medical Devices in India, manufacturers and importers must comply with the Medical Device Rules, 2017 under the Drugs and Cosmetics Act, 1940. The Central Drugs Standard Control Organization (CDSCO) is the regulatory authority responsible for granting registration and licenses for medical devices, including Gastroenterological devices such as endoscopes, feeding tubes, biopsy forceps, stents, and capsule endoscopy systems.

Step 1: Determine Device Classification

Identify the risk class (A, B, C, or D) of the gastroenterological device as per the Medical Device Rules (2017).

Step 2: Appoint an Indian Authorized Agent (For Foreign Manufacturers)

Foreign manufacturers must appoint an authorized local representative in India to liaise with CDSCO. Here’s a complete overview on how to appoint an Indian Authorized Agent for foreign manufacturers, particularly in regulatory contexts like CDSCO (Central Drugs Standard Control Organization), BIS (Bureau of Indian Standards), or FSSAI (Food Safety and Standards Authority of India)

An Indian Authorized Agent (IAA) is a legally recognized representative appointed by a foreign manufacturer to act on their behalf in India for regulatory purposes. The agent must be an Indian entity with a valid import-export code and preferably have relevant regulatory approvals or licenses.

Step 3: Compile Required Documents

The essential documents include:

Device master file with technical specifications
Clinical trial data (if applicable for Class C & D devices)
Quality management system certificates (ISO 13485)
Free Sale Certificate (FSC) from the country of origin
Labelling and user manual details

Additional documents are typically required

Cover letter with product details
Device Master File (DMF) / Plant Master File (PMF)
ISO 13485 certification
Free Sale Certificate (for imported devices)
Clinical evaluation report
Product labels and brochures
Undertaking by manufacturer/importer
CE Certificate (if applicable)
Manufacturing license (for domestic manufacturers)
Power of Attorney (if applicable)

Step 4: Submit Application and Pay Fees

The application must be filed via the CDSCO’s online portal along with the requisite fees, which vary based on device class. In case you are facing any issue related to Registration and process, Feet free to contact us on 9988424211 or Email info@ccoffice.in

Device Class	Registration Fee (INR)
Class A & B	50,000
Class C & D	1,00,000

Step 5: CDSCO Evaluation and Approval

Once the application for CDSCO registration is submitted (either for import or manufacture), the next crucial step is evaluation and approval by the Central Drugs Standard Control Organization (CDSCO). This process ensures that only safe, effective, and quality-assured Gastroenterological devices are permitted for sale in India.

Renewal and Validity of CDSCO Registration

The CDSCO registration for medical devices is valid for five years. Manufacturers must apply for renewal at least six months before expiry. The renewal process involves submitting updated documents, including any changes in device specifications or regulatory status.

Top 5 Market Leaders in Gastroenterological Medical Devices in India

Olympus Medical Systems India (Maharashtra) – A global leader in endoscopy and minimally invasive surgical devices.
Fujifilm India (Delhi) – Specializes in advanced endoscopic imaging systems.
Boston Scientific India (Karnataka) – Known for innovative stents and endoscopic surgical tools.
Karl Storz India (Gujarat) – Provides high-quality laparoscopic and endoscopic instruments.
Medtronic India (Telangana) – Offers a wide range of gastroenterological and surgical devices.

FAQs

Q1. What is CDSCO registration for Gastroenterological devices?

Ans. CDSCO registration is a regulatory approval process by the Central Drugs Standard Control Organization that allows manufacturers or importers to legally sell gastroenterological medical devices in India.

Q2. Is CDSCO registration mandatory for all Gastroenterological devices?

Ans. Yes, as per the Medical Device Rules, 2017, registration is mandatory for all Class A, B, C, and D gastroenterology devices notified by CDSCO.

Q3. What types of Gastroenterological devices require registration?

Ans. Devices such as endoscopes, biopsy forceps, stents, feeding tubes, capsule endoscopy systems, and GI catheters require CDSCO registration.

Q4. How are Gastroenterological devices classified in India?

Ans. They are classified based on risk:

Class A (Low risk)
Class B (Low-moderate risk)
Class C (Moderate-high risk)
Class D (High risk)

Most GI devices fall under Class B to D.

Q5. Who can apply for CDSCO registration?

Ans. Manufacturers (for domestic production) and Authorized Indian Agents (for foreign manufacturers) can apply for registration through the CDSCO’s Sugam portal.

Q6. What documents are required for CDSCO registration?

Ans. Key documents include ISO 13485 certificate, Free Sale Certificate, CE Certificate (if available), Device Master File, Plant Master File, and an undertaking by the applicant.

Q7. What is the fee for obtaining CDSCO registration?

Ans. Fees vary by device class and number of models. For example, Class B import license may cost Rs.1,000 per model, whereas Class D may cost up to Rs.50,000.

Q8. How long does it take to get CDSCO approval?

Ans. Approval time varies by device class:

Class A & B: Around 4–8 weeks
Class C & D: Around 3–6 months (may require clinical evaluation and SEC review)

Q9. What is the validity of the CDSCO registration certificate?

Ans. The CDSCO license is valid for 5 years from the date of issue, subject to compliance with post-market obligations.

Q10. Can I renew my CDSCO registration?

Ans. Yes. Renewal must be applied for at least 6 months before expiry of the existing license by submitting updated documents and paying the renewal fee.