Regulations & Process to Sell and Stay Compliant in the Indian Market
Navigating India Medical Device Regulations: CDSCO Medical Device Registration India and Approval Process
For India Approval, Medical Device Manufacturers, can leverage approvals in GHTF Countries and its Classification in the home country. Morulaa’s experience with the CDSCO India import license form, MD14 and the Medical Device Rules India 2017, ensures that manufacturers products meet regulatory requirements. We provide comprehensive India regulatory services to help navigate regulatory pathways, regulatory submissions, and regulatory compliance, focusing on quick market access for your products.
Being an experienced CDSCO Medical device India authorized representative, we streamline the Medical device regulations and registration process India, ensuring compliance. With extensive experience working with Central Drugs Standard Control Organization (CDSCO), we can effectively manage the India regulation landscape, ensuring faster approval time for your products. Morulaa has a deep understanding of CDSCO’s requirements, offering comprehensive support throughout the CDSCO medical device registration process India.
Navigating India Medical Device Regulations: CDSCO Medical Device Registration and Approval Process
For India Approval, Medical Device Manufacturers, can leverage approvals in GHTF Countries and its Classification in the home country. Morulaa’s experience with the CDSCO India import license form, MD14 and the Medical Device Rules India 2017, ensures that manufacturers products meet regulatory requirements. We provide comprehensive India regulatory services to help navigate regulatory pathways, regulatory submissions, and regulatory compliance, focusing on quick market access for your products.
Being an experienced CDSCO Medical device India authorized representative, we streamline the Medical device regulations and registration process India, ensuring compliance. With extensive experience working with Central Drugs Standard Control Organization (CDSCO), we can effectively manage the India regulation landscape, ensuring faster approval time for your products. Morulaa has a deep understanding of CDSCO’s requirements, offering comprehensive support throughout the CDSCO medical device registration process India.
Register Your Medical Device in India
In India Medical device regulations is managed by the Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health. These devices are regulated by the Drugs and Cosmetics Act of 1940. Our expertise with CDSCO import license form MD14 and adherence to the Medical Device Rules India 2017 to ensure that your products meet regulatory standards. We provide a wide range of regulatory services in India, assisting you through the regulatory landscape.
Our Regulatory services include everything from registration to market access for your devices in India. We are well-versed in notified requirements, and we handle all India Medical device registration process with precision. Trust Morulaa to ensure compliance with CDSCO guidelines, facilitating smooth regulatory processes like CDSCO medical device registration process India and efficient approval time for your products.
Register Your Medical Device in India
In India Medical device regulations is managed by the Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health. These devices are regulated by the Drugs and Cosmetics Act of 1940. Our expertise with CDSCO import license form MD14 and adherence to the Medical Device Rules India 2017 to ensure that your products meet regulatory standards. We provide a wide range of regulatory services in India, assisting you through the regulatory landscape.
Our Regulatory services include everything from registration to market access for your devices in India. We are well-versed in notified requirements, and we handle all India Medical device registration process with precision. Trust Morulaa to ensure compliance with CDSCO guidelines, facilitating smooth regulatory processes like CDSCO medical device registration process India and efficient approval time for your products.
How Morulaa Can Support Your Sales into India
How Morulaa Can Support Your Sales into India
Why Select Morulaa as Your CDSCO Medical device Authorized Representative For India:
Choosing the right India Agent is critical as it determines your entire supply chain into the market. The license holder can be a local subsidiary, India independent agent, or distributor. Using an India independent agent like Morulaa can be the most economical and secure method for maintaining compliance with the CDSCO medical device registration process India, While providing manufacturers with commercial freedom when working with their distribution partners.
Selecting Morulaa as your regulatory importer ensures compliance in your distribution chain with minimal effort. We simplify regulatory compliance by helping you register medical device in India and navigate the CDSCO India medical device approval process. We have assisted over 500 medical device and IVD manufacturers. Morulaa offers a seamless solution to meet compliance regulations, especially under the new EU MDR and IVDR, which have similar requirements in the UK, Switzerland, the US, India, and Australia.
We are well-versed in the India CDSCO import license form MD14, Medical Device Rules India 2017, regulatory procedures, and CDSCO requirements.
Questions To Enquire With Any Company Prior to Selecting Your India Authorized Agent
- Do they have experience in dealing with CDSCO, Recalls, Post Approval Changes Device Changes?
- Is the company compliant with NPPA, Legal Metrology, Plastic Waste, Electronic Waste, Battery, WPC and other compliances?
- How many shipments do they handle on a monthly basis?
- What are the type of Products they have previously registered? How many products are approved under their name ?
Why Select Morulaa as Your CDSCO Medical device Authorized Representative For India:
Choosing the right India Agent is critical as it determines your entire supply chain into the market. The license holder can be a local subsidiary, India independent agent, or distributor. Using an India independent agent like Morulaa can be the most economical and secure method for maintaining compliance with the CDSCO medical device registration process India, While providing manufacturers with commercial freedom when working with their distribution partners.
Selecting Morulaa as your regulatory importer ensures compliance in your distribution chain with minimal effort. We simplify regulatory compliance by helping you register medical device in India and navigate the CDSCO India medical device approval process. We have assisted over 500 medical device and IVD manufacturers. Morulaa offers a seamless solution to meet compliance regulations, especially under the new EU MDR and IVDR, which have similar requirements in the UK, Switzerland, the US, India, and Australia.
We are well-versed in the India CDSCO import license form MD14, Medical Device Rules India 2017, regulatory procedures, and CDSCO requirements.
Questions To Enquire With Any Company Prior to Selecting Your India Authorized Agent
- Do they have experience in dealing with CDSCO, Recalls, Post Approval Changes Device Changes?
- Is the company compliant with NPPA, Legal Metrology, Plastic Waste, Electronic Waste, Battery, WPC and other compliances?
- How many shipments do they handle on a monthly basis?
- What are the type of Products they have previously registered? How many products are approved under their name ?
EU-MDR CLASSIFICATION |
INDIAN CLASSIFICATION |
|---|---|
|
Class I Self-Certified under EU MDR |
Class A Self-Notified
(non-sterile, non-measuring) |
|
Class I Notified EU MDR |
Class A Notified |
|
Class IIa EU MDR |
Class B |
|
Class IIb EU MDR |
Class C |
|
Class III EU MDR |
Class D |
Morulaa Helps Classify Your Device
According to the G.S.R. 777(E) notification by the CDSCO (Central Drugs Standard Control Organization) on October 14, 2022, Class A Non-Sterile and Non-Measuring devices are Self-Notified, while other medical devices require CDSCO review as part of the CDSCO India medical device approval process. Self-Notified (Class A – Non-Sterile and Non-Measuring) devices allow us as the India Authorized Agent, to obtain an automatic registration number on the SUGAM portal for exporting into India. All other classes need a document review by the CDSCO to obtain the Import License.
Manufacturers should refer to the actual rules in the India MDR guidelines, to understand their classification. Central Drugs Standard Control Organization (CDSCO) offers product listings with Generic Name, Intended Use, and Class to assist manufacturers in determining the proper classification for their devices in India. The India classification system closely mirrors the EU-MDR classification, providing a valuable reference for manufacturers. Morulaa’s experience with India CDSCO import license form MD14, Medical Device Rules India 2017, and regulatory compliance ensures that your products meet all necessary registration process .
We provide comprehensive regulatory services, guiding you through the regulatory landscape.
Morulaa Helps Classify Your Device
According to the G.S.R. 777(E) notification by the CDSCO (Central Drugs Standard Control Organization) on October 14, 2022, Class A Non-Sterile and Non-Measuring devices are Self-Notified, while other medical devices require CDSCO review as part of the CDSCO India medical device approval process. Self-Notified (Class A – Non-Sterile and Non-Measuring) devices allow us as the India Authorized Agent, to obtain an automatic registration number on the SUGAM portal for exporting into India. All other classes need a document review by the CDSCO to obtain the Import License.
Manufacturers should refer to the actual rules in the India MDR guidelines, to understand their classification. Central Drugs Standard Control Organization (CDSCO) offers product listings with Generic Name, Intended Use, and Class to assist manufacturers in determining the proper classification for their devices in India. The India classification system closely mirrors the EU-MDR classification, providing a valuable reference for manufacturers. Morulaa’s experience with India CDSCO import license form MD14, Medical Device Rules India 2017, and regulatory compliance ensures that your products meet all necessary registration process .
We provide comprehensive regulatory services, guiding you through the regulatory landscape.
EU-MDR CLASSIFICATION |
INDIAN CLASSIFICATION |
|---|---|
|
Class I Self-Certified under
EU MDR |
Class A Self-Notified
(non-sterile, non-measuring) |
|
Class I Notified
EU MDR |
Class A
Notified |
|
Class II
EU MDR |
Class B |
|
Class IIb
EU MDR |
Class C |
|
Class III
EU MDR |
Class D |
Documents & Fees Needed To Register Your Medical Device in India
Low Risk to High Risk Devices
Legacy and Novel Devices
- Certification documents (ISO 13485, Free Sale Certificate, Declaration of Conformity, etc.)
- Manufacturing Site documents (Plant Master File)
- Technical File documents (Device Master File)
The overall document requirement is as above
However, if you are a legacy and novel device, then there are certain additional documentations you need to comply with to start selling in India.
Device Class |
Manufacturing Site Fees (Per Legal Site) |
Device Family Fees (Per Device Family) |
|---|---|---|
|
Class A Self-Notified
|
US $0.00 |
US $0.00 |
|
Class A Notified
|
US $1000.00 |
US $50.00 |
|
Class B |
US $2000.00 |
US $1000.00 |
|
Class C |
US $3000.00 |
US $1500.00 |
|
Class D |
US $3000.00 |
US $1500.00 |
Device Class |
Manufacturing Site Fees (Per Legal Site) |
Device Family Fees (Per Device Family) |
|---|---|---|
|
Class A Self-Notified
|
US $0.00 |
US $0.00 |
|
Class A Notified
|
US $1000.00 |
US $50.00 |
|
Class B |
US $2000.00 |
US $1000.00 |
|
Class C |
US $3000.00 |
US $1500.00 |
|
Class D |
US $3000.00 |
US $1500.00 |
Documents & Fees Needed To Register Your Medical Device in India
Low Risk to High Risk Devices
Legacy and Novel Devices
- Certification documents (ISO 13485, Free Sale Certificate, Declaration of Conformity, etc.)
- Manufacturing Site documents (Plant Master File)
- Technical File documents (Device Master File)
The overall document requirement is as above
However, if you are a legacy and novel device, then there are certain additional documentations you need to comply with to start selling in India.
Expert Guidance on Medical Device Regulations India: Local Teams Navigating CDSCO Registration Process India and Regulatory Compliance
The continuously evolving requirements of India require a strong partnership with a compliance firm offering regulatory services, no matter how you decide to do business—either direct or via a distributor. We are here to be a part of your journey in our beautiful land of opportunities.
At Morulaa, we specialize in India CDSCO Medical device approval process, India Import license form MD14, Medical Device Rules India 2017, and regulatory compliance, offering expert guidance through all regulatory processes. Our local teams have a deep understanding of the India market and work closely with CDSCO (Central Drugs Standard Control Organization) to ensure that all India Medical device regulations are met. We provide comprehensive support for India registration process, including handling notified devices and ensuring timely approval time. Morulaa is your trusted partner, a CDSCO India authorized representative for navigating the complexities regulatory landscape, ensuring smooth market access and compliance with all medical device registration process India.
Expert Guidance on Medical Device Regulations India: Local Teams Navigating CDSCO Registration Process India and Regulatory Compliance
The continuously evolving requirements of India require a strong partnership with a compliance firm offering regulatory services, no matter how you decide to do business—either direct or via a distributor. We are here to be a part of your journey in our beautiful land of opportunities.
At Morulaa, we specialize in India CDSCO Medical device approval process, India Import license form MD14, Medical Device Rules India 2017, and regulatory compliance, offering expert guidance through all regulatory processes. Our local teams have a deep understanding of the India market and work closely with CDSCO (Central Drugs Standard Control Organization) to ensure that all India Medical device regulations are met. We provide comprehensive support for India registration process, including handling notified devices and ensuring timely approval time. Morulaa is your trusted partner, a CDSCO India authorized representative for navigating the complexities regulatory landscape, ensuring smooth market access and compliance with all medical device registration process India.