CDSCO Registration for Dermatology and Plastic Surgery Medical Devices

CDSCO Registration for Dermatology and Plastic Surgery Medical Devices. CDSCO Registration for Dermatology and Plastic Surgery Medical Devices is now mandatory in India as per the notification issued by the Drugs Controller General of India (DCGI). The regulation aims to bring these devices under the purview of the Medical Device Rules, 2017, to ensure that they meet safety, performance, and quality standards. On 26th July 2021, the DCGI released notification S.O. 648 (E) & GSR 102 (E), listing out 55 dermatology and plastic surgery-related medical devices to be regulated under CDSCO. These devices are classified based on risk and require proper registration before import, manufacturing, or sale in India.
CDSCO Regulation on Medical Device Rules, 2017
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules, 2017. The rules classify medical devices into four categories based on the associated risk: Class A (low risk), Class B (low-moderate risk), Class C (moderate-high risk), and Class D (high risk). Each classification determines the level of regulatory control required for that device.
As per the rules, any individual or business involved in the import, manufacture, sale, or distribution of medical devices must adhere to guidelines issued by the Ministry of Health and Family Welfare. These rules ensure that evolving technology and advancements in medical devices are taken into account for regulatory compliance.
What are Medical Devices?
A medical device can be defined as any instrument, machine, implant, reagent, software, or similar product used for medical purposes. These include diagnostic devices, surgical tools, implants, and even mobile apps used for medical monitoring. Medical devices can be categorized into notified and non-notified devices depending on whether they fall under the mandatory list released by the government.
Before 2006, medical devices in India operated in an unregulated market. Manufacturers could market and sell devices freely without compliance requirements. However, with the introduction of the Indian Medical Device Regulations, such activities were brought under control, ensuring only safe and effective devices reach patients.
Functions of CDSCO
CDSCO plays an important role in ensuring the safety and quality of medical devices in India. Its functions include:

Registration of medical devices for manufacturing and import

Formulating standards and regulations for medical devices, drugs, and in-vitro diagnostics

Regulating market authorization and overseeing clinical trials

Granting manufacturing licenses and regulating imported drugs

Conducting drug testing through central laboratories

The organization ensures that all processes adhere to current laws and quality benchmarks.
Risk-Based Classification of Medical Devices
The classification of medical devices is based on the degree of risk they pose to patients. Devices used in dermatology and plastic surgery are categorized under different risk levels depending on their application. For example, a skin stapler poses a higher risk than a surgical glove. Based on risk, medical devices are grouped into four classes:

Class A: Low risk

Class B: Low to moderate risk

Class C: Moderate to high risk

Class D: High risk

Every manufacturer must apply for CDSCO registration according to the risk category their product falls under. Higher the risk, more stringent the registration requirements.
Non-Notified Medical Devices and Recent Updates
Earlier, CDSCO regulated only 37 notified devices. However, on 11th February 2020, the Ministry of Health and Family Welfare issued a notice stating that all medical devices will now be regulated. A deadline was given for voluntary registration — for Class A and B devices, the deadline was 1st October 2022, and for Class C and D devices, it was 1st October 2023. After these dates, registration became mandatory.
On 3rd September 2020, another notification added 24 categories of non-notified devices to the CDSCO regulation list. This included Dermatology and Plastic Surgery Medical Devices, along with other categories such as Dental, ENT, Cardiovascular, Neurological, and Paediatric devices.
CDSCO Classification for Dermatology and Plastic Surgery Devices
CDSCO has issued a detailed list of 55 dermatology and plastic surgery medical devices along with their respective risk classifications. Some examples include:

Surgical camera and accessories (Class A)

Electrosurgical cutting device (Class C)

Ultraviolet lamp for dermatologic disorders (Class B)

Dermatome (Class A)

Liposuction catheter (Class B)

Skin stapler (Class B)

The classification helps manufacturers and importers understand the level of regulation their product needs to meet. Devices that involve direct contact with human tissues or carry higher risks are placed in higher classes.
Documentation Required for CDSCO Registration
To register Dermatology and Plastic Surgery Medical Devices with CDSCO, the applicant must submit specific documents. These include:

Application Form: Contains product details and applicant credentials.

Challan TR6: Proof of fee payment to the government.

ISO 13485 Certificate: Indicates compliance with international quality standards.

Power of Attorney: Appoints an authorized representative in India if the manufacturer is foreign.

Undertaking: A declaration that all submitted information is true and verified.

Certificate of Quality Assurance: Proves the product has undergone quality checks.

CE Certificate: If applicable, certifies product compliance with European norms.

Declaration of Conformity: Manufacturer’s statement that product meets applicable standards.

Schedule D(I): Product-specific document as required by CDSCO.

Master Plant File and Device Master File: Detail manufacturing process, equipment, and controls.

Free Sale Certificate: Indicates product is legally sold in other major markets.

These documents are important in proving that the device is safe, effective, and meets Indian regulatory requirements.
Procedure for CDSCO Registration for Dermatology and Plastic Surgery Medical Devices
The process for CDSCO Registration for Dermatology and Plastic Surgery Medical Devices includes the following steps:
Step 1: Identification of Medical Device The applicant must verify whether the device is notified or non-notified under CDSCO. Non-notified devices listed under the 3rd September 2020 notification must still be registered within the prescribed deadline. This first step helps determine the regulatory route and timelines.
Step 2: Classification Based on Risk Next, the medical device should be classified according to the associated risk. Depending on the classification (A, B, C, or D), the registration requirements vary. Higher-risk devices need more documentation and evaluation.
Step 3: Appointment of Indian Authorized Agent (IAA) If the manufacturer is not based in India, they must appoint an Indian Authorized Agent (IAA). This agent is responsible for communication with CDSCO and ensures all documents are submitted properly. The IAA must be a licensed entity authorized to handle medical device registration.
Step 4: Preparation and Submission of Documents Once the classification is confirmed and an agent is appointed (if needed), the applicant prepares all required documents. This includes all technical and regulatory documents listed earlier. Each document must be verified and formatted according to CDSCO standards.
Step 5: Review and Grant of License After submission, CDSCO reviews the documents and may ask for clarifications. Upon satisfaction, the registration license is issued. This license allows the manufacturer or importer to market and distribute the medical device in India legally.
Conclusion
CDSCO Registration for Dermatology and Plastic Surgery Medical Devices is a significant regulatory requirement in India aimed at ensuring the safety and effectiveness of medical devices used in sensitive treatments. The registration process involves detailed classification, documentation, and legal procedures that must be followed diligently. Manufacturers and importers must keep track of CDSCO notifications and comply with deadlines to avoid regulatory delays. Given the technical nature and strict compliance involved, it is always advisable to seek expert assistance to streamline the process and ensure that the device reaches the Indian market without unnecessary obstacles.
If you need any support in CDSCO Registration, book a consultation with Compliance Calendar experts through email at info@ccoffice.in or Call/Whatsapp at +91 9988424211.
FAQs
Q1. What is CDSCO Registration for Dermatology and Plastic Surgery Medical Devices?
 Ans. CDSCO Registration for Dermatology and Plastic Surgery Medical Devices is a mandatory approval process by the Central Drugs Standard Control Organization (CDSCO) for the import, manufacture, and sale of devices used in dermatology and plastic surgery in India. The registration ensures that these devices meet safety, quality, and performance standards under the Medical Device Rules, 2017.
Q2. Is it mandatory to register all dermatology and plastic surgery devices with CDSCO?
Ans. Yes, it is mandatory to register these devices with CDSCO. As per the notice dated 3rd September 2020, all such devices are now classified as non-notified medical devices. While initial registration was voluntary, it became mandatory after October 2022 for Class A and B devices, and after October 2023 for Class C and D devices.
Q3. What documents are required for CDSCO Registration for Dermatology and Plastic Surgery Medical Devices?
Ans. The required documents include an application form, TR6 challan, ISO 13485 certificate, Power of Attorney, CE Certificate (if any), Free Sale Certificate, Schedule D(I), Master Plant File, Device Master File, and an undertaking of accuracy. These help validate the safety and quality of the medical device.
Q4. How are these devices classified under CDSCO?
Ans. CDSCO classifies dermatology and plastic surgery devices based on risk levels into four categories—Class A (low risk), Class B (low to moderate risk), Class C (moderate to high risk), and Class D (high risk). For example, surgical gloves fall under Class A, while electrosurgical devices fall under Class C.
Q5. Who can apply for CDSCO registration in India?
Ans. Indian manufacturers can apply directly. For foreign manufacturers, an Indian Authorized Agent (IAA) must be appointed. The IAA acts on behalf of the foreign entity and manages the entire registration and compliance process in India.
Q6. What is the validity period of CDSCO Registration once obtained?
Ans. CDSCO registration is typically valid for five years from the date of issuance, unless otherwise specified. Renewals must be applied for before the expiry date to avoid disruption in manufacturing or sales operations.
Q7. Why is CDSCO Registration important for dermatology and plastic surgery devices?
Ans. CDSCO Registration ensures that only tested and quality-compliant devices reach healthcare providers and patients. It protects public health, supports regulatory oversight, and builds trust in the safety and reliability of the medical devices used in dermatological and cosmetic procedures.

CDSCO Registration for Dermatology and Plastic Surgery Medical Devices is now mandatory in India as per the notification issued by the Drugs Controller General of India (DCGI). The regulation aims to bring these devices under the purview of the Medical Device Rules, 2017, to ensure that they meet safety, performance, and quality standards. On 26th July 2021, the DCGI released notification S.O. 648 (E) & GSR 102 (E), listing out 55 dermatology and plastic surgery-related medical devices to be regulated under CDSCO. These devices are classified based on risk and require proper registration before import, manufacturing, or sale in India.

CDSCO Regulation on Medical Device Rules, 2017

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules, 2017. The rules classify medical devices into four categories based on the associated risk: Class A (low risk), Class B (low-moderate risk), Class C (moderate-high risk), and Class D (high risk). Each classification determines the level of regulatory control required for that device.

As per the rules, any individual or business involved in the import, manufacture, sale, or distribution of medical devices must adhere to guidelines issued by the Ministry of Health and Family Welfare. These rules ensure that evolving technology and advancements in medical devices are taken into account for regulatory compliance.

What are Medical Devices?

A medical device can be defined as any instrument, machine, implant, reagent, software, or similar product used for medical purposes. These include diagnostic devices, surgical tools, implants, and even mobile apps used for medical monitoring. Medical devices can be categorized into notified and non-notified devices depending on whether they fall under the mandatory list released by the government.

Before 2006, medical devices in India operated in an unregulated market. Manufacturers could market and sell devices freely without compliance requirements. However, with the introduction of the Indian Medical Device Regulations, such activities were brought under control, ensuring only safe and effective devices reach patients.

Functions of CDSCO

CDSCO plays an important role in ensuring the safety and quality of medical devices in India. Its functions include:

Registration of medical devices for manufacturing and import
Formulating standards and regulations for medical devices, drugs, and in-vitro diagnostics
Regulating market authorization and overseeing clinical trials
Granting manufacturing licenses and regulating imported drugs
Conducting drug testing through central laboratories

The organization ensures that all processes adhere to current laws and quality benchmarks.

Risk-Based Classification of Medical Devices

The classification of medical devices is based on the degree of risk they pose to patients. Devices used in dermatology and plastic surgery are categorized under different risk levels depending on their application. For example, a skin stapler poses a higher risk than a surgical glove. Based on risk, medical devices are grouped into four classes:

Class A: Low risk
Class B: Low to moderate risk
Class C: Moderate to high risk
Class D: High risk

Every manufacturer must apply for CDSCO registration according to the risk category their product falls under. Higher the risk, more stringent the registration requirements.

Non-Notified Medical Devices and Recent Updates

Earlier, CDSCO regulated only 37 notified devices. However, on 11th February 2020, the Ministry of Health and Family Welfare issued a notice stating that all medical devices will now be regulated. A deadline was given for voluntary registration — for Class A and B devices, the deadline was 1st October 2022, and for Class C and D devices, it was 1st October 2023. After these dates, registration became mandatory.

On 3rd September 2020, another notification added 24 categories of non-notified devices to the CDSCO regulation list. This included Dermatology and Plastic Surgery Medical Devices, along with other categories such as Dental, ENT, Cardiovascular, Neurological, and Paediatric devices.

CDSCO Classification for Dermatology and Plastic Surgery Devices

CDSCO has issued a detailed list of 55 dermatology and plastic surgery medical devices along with their respective risk classifications. Some examples include:

Surgical camera and accessories (Class A)
Electrosurgical cutting device (Class C)
Ultraviolet lamp for dermatologic disorders (Class B)
Dermatome (Class A)
Liposuction catheter (Class B)
Skin stapler (Class B)

Documentation Required for CDSCO Registration

To register Dermatology and Plastic Surgery Medical Devices with CDSCO, the applicant must submit specific documents. These include:

Application Form: Contains product details and applicant credentials.
Challan TR6: Proof of fee payment to the government.
ISO 13485 Certificate: Indicates compliance with international quality standards.
Power of Attorney: Appoints an authorized representative in India if the manufacturer is foreign.
Undertaking: A declaration that all submitted information is true and verified.
Certificate of Quality Assurance: Proves the product has undergone quality checks.
CE Certificate: If applicable, certifies product compliance with European norms.
Declaration of Conformity: Manufacturer’s statement that product meets applicable standards.
Schedule D(I): Product-specific document as required by CDSCO.
Master Plant File and Device Master File: Detail manufacturing process, equipment, and controls.
Free Sale Certificate: Indicates product is legally sold in other major markets.

These documents are important in proving that the device is safe, effective, and meets Indian regulatory requirements.

Procedure for CDSCO Registration for Dermatology and Plastic Surgery Medical Devices

The process for CDSCO Registration for Dermatology and Plastic Surgery Medical Devices includes the following steps:

Step 1: Identification of Medical Device The applicant must verify whether the device is notified or non-notified under CDSCO. Non-notified devices listed under the 3rd September 2020 notification must still be registered within the prescribed deadline. This first step helps determine the regulatory route and timelines.

Step 2: Classification Based on Risk Next, the medical device should be classified according to the associated risk. Depending on the classification (A, B, C, or D), the registration requirements vary. Higher-risk devices need more documentation and evaluation.

Step 3: Appointment of Indian Authorized Agent (IAA) If the manufacturer is not based in India, they must appoint an Indian Authorized Agent (IAA). This agent is responsible for communication with CDSCO and ensures all documents are submitted properly. The IAA must be a licensed entity authorized to handle medical device registration.

Step 4: Preparation and Submission of Documents Once the classification is confirmed and an agent is appointed (if needed), the applicant prepares all required documents. This includes all technical and regulatory documents listed earlier. Each document must be verified and formatted according to CDSCO standards.

Step 5: Review and Grant of License After submission, CDSCO reviews the documents and may ask for clarifications. Upon satisfaction, the registration license is issued. This license allows the manufacturer or importer to market and distribute the medical device in India legally.

Conclusion

CDSCO Registration for Dermatology and Plastic Surgery Medical Devices is a significant regulatory requirement in India aimed at ensuring the safety and effectiveness of medical devices used in sensitive treatments. The registration process involves detailed classification, documentation, and legal procedures that must be followed diligently. Manufacturers and importers must keep track of CDSCO notifications and comply with deadlines to avoid regulatory delays. Given the technical nature and strict compliance involved, it is always advisable to seek expert assistance to streamline the process and ensure that the device reaches the Indian market without unnecessary obstacles.

If you need any support in CDSCO Registration, book a consultation with Compliance Calendar experts through email at info@ccoffice.in or Call/Whatsapp at +91 9988424211.

FAQs

Q1. What is CDSCO Registration for Dermatology and Plastic Surgery Medical Devices?

Ans. CDSCO Registration for Dermatology and Plastic Surgery Medical Devices is a mandatory approval process by the Central Drugs Standard Control Organization (CDSCO) for the import, manufacture, and sale of devices used in dermatology and plastic surgery in India. The registration ensures that these devices meet safety, quality, and performance standards under the Medical Device Rules, 2017.

Q2. Is it mandatory to register all dermatology and plastic surgery devices with CDSCO?

Ans. Yes, it is mandatory to register these devices with CDSCO. As per the notice dated 3rd September 2020, all such devices are now classified as non-notified medical devices. While initial registration was voluntary, it became mandatory after October 2022 for Class A and B devices, and after October 2023 for Class C and D devices.

Q3. What documents are required for CDSCO Registration for Dermatology and Plastic Surgery Medical Devices?

Ans. The required documents include an application form, TR6 challan, ISO 13485 certificate, Power of Attorney, CE Certificate (if any), Free Sale Certificate, Schedule D(I), Master Plant File, Device Master File, and an undertaking of accuracy. These help validate the safety and quality of the medical device.

Q4. How are these devices classified under CDSCO?

Ans. CDSCO classifies dermatology and plastic surgery devices based on risk levels into four categories—Class A (low risk), Class B (low to moderate risk), Class C (moderate to high risk), and Class D (high risk). For example, surgical gloves fall under Class A, while electrosurgical devices fall under Class C.

Q5. Who can apply for CDSCO registration in India?

Ans. Indian manufacturers can apply directly. For foreign manufacturers, an Indian Authorized Agent (IAA) must be appointed. The IAA acts on behalf of the foreign entity and manages the entire registration and compliance process in India.

Q6. What is the validity period of CDSCO Registration once obtained?

Ans. CDSCO registration is typically valid for five years from the date of issuance, unless otherwise specified. Renewals must be applied for before the expiry date to avoid disruption in manufacturing or sales operations.

Q7. Why is CDSCO Registration important for dermatology and plastic surgery devices?

Ans. CDSCO Registration ensures that only tested and quality-compliant devices reach healthcare providers and patients. It protects public health, supports regulatory oversight, and builds trust in the safety and reliability of the medical devices used in dermatological and cosmetic procedures.