Regulations & Process to Sell and Stay Compliant in the Indian Market
Based on Classification of the Device and Pre-Approval in USA, EU, UK, Canada, Australia & Japan
The Indian Approval System allows Medical Device Manufacturers, to leverage approvals in GHTF Countries its Classification in the home country. Morulaa’s experience with the MD14 process and the Medical Device Rules, 2017 ensures that manufacturers products meet regulatory requirements in India. We help navigate regulatory pathways, regulatory submissions, and regulatory compliance, focusing on quick market access for your products in the Indian context.
Being an experienced In-Country Representative, we streamline the regulation and registration processes, ensuring compliance with Indian standards. With extensive experience working with 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 registration and classification processes.
Based on Classification of the Device and Pre-Approval in USA, EU, UK, Canada, Australia & Japan
The Indian Approval System allows Medical Device Manufacturers, to leverage approvals in GHTF Countries its Classification in the home country. Morulaa’s experience with the MD14 process and the Medical Device Rules, 2017 ensures that manufacturers products meet regulatory requirements in India. We help navigate regulatory pathways, regulatory submissions, and regulatory compliance, focusing on quick market access for your products in the Indian context.
Being an experienced In-Country Representative, we streamline the regulation and registration processes, ensuring compliance with Indian standards. With extensive experience working with 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 registration and classification processes.
Register Your Medical Device in India
Medical device regulation in India 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 MD14 and adherence to the Medical Device Rules, 2017 ensure that your products meet regulatory standards by India. We provide complete regulatory support, guiding you through the regulatory landscape.
This includes everything from registration to market access for your devices in India. We are well-versed in notified requirements, and we handle all regulation and registration aspects with precision. Trust Morulaa to ensure compliance with CDSCO guidelines, facilitating smooth regulatory processes and efficient approval time for your products.
Register Your Medical Device in India
Medical device regulation in India 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 MD14 and adherence to the Medical Device Rules, 2017 ensure that your products meet regulatory standards by India. We provide complete regulatory support, guiding you through the regulatory landscape.
This includes everything from registration to market access for your devices in India. We are well-versed in notified requirements, and we handle all regulation and registration aspects with precision. Trust Morulaa to ensure compliance with CDSCO guidelines, facilitating smooth regulatory processes 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 Indian Agent
Choosing the right Indian Agent is critical as it determines your entire supply chain into the market. The license holder can be a local subsidiary, independent agent, or distributor. Using an independent agent like Morulaa can be the most economical and secure method for maintaining compliance, 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 for 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 MD14 process, Medical Device Rules, 2017, regulatory procedures, and CDSCO requirements.
Questions To Enquire With Any Company Prior to Selecting Your Indian 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 Indian Agent
Choosing the right Indian Agent is critical as it determines your entire supply chain into the market. The license holder can be a local subsidiary, independent agent, or distributor. Using an independent agent like Morulaa can be the most economical and secure method for maintaining compliance, 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 for 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 MD14 process, Medical Device Rules, 2017, regulatory procedures, and CDSCO requirements.
Questions To Enquire With Any Company Prior to Selecting Your Indian 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 on October 14, 2022, Class A Non-Sterile and Non-Measuring devices are Self-Notified, while other medical devices require CDSCO review. Self-Notified (Class A – Non-Sterile and Non-Measuring) devices allow us, as the Indian 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 MDR guidelines, India, to understand their classification. 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 Indian classification system closely mirrors the EU-MDR classification, providing a valuable reference for manufacturers. Morulaa’s experience with MD14, Medical Device Rules, 2017, and regulatory compliance ensures that your products meet all necessary regulations.
We provide comprehensive regulatory support, ensuring seamless registration and efficient approval time.
Morulaa Helps Classify Your Device
According to the G.S.R. 777(E) notification by the CDSCO on October 14, 2022, Class A Non-Sterile and Non-Measuring devices are Self-Notified, while other medical devices require CDSCO review. Self-Notified (Class A – Non-Sterile and Non-Measuring) devices allow us, as the Indian 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 MDR guidelines, India, to understand their classification. 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 Indian classification system closely mirrors the EU-MDR classification, providing a valuable reference for manufacturers. Morulaa’s experience with MD14, Medical Device Rules, 2017, and regulatory compliance ensures that your products meet all necessary regulations.
We provide comprehensive regulatory support, ensuring seamless registration and efficient approval time.
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 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 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.
Specialized India-specific focus with local Indian teams who understand the nuances of doing business in India
The continuously evolving requirements of India require a strong partnership with a compliance firm, 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 MD14, Medical Device Rules, 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 to ensure that all regulations are met. We provide comprehensive support for registration, including handling notified devices and ensuring timely approval time. Morulaa is your trusted partner for navigating the complexities of the India regulatory landscape, ensuring smooth market access and compliance with all CDSCO requirements
Specialized India-specific focus with local Indian teams who understand the nuances of doing business in India
The continuously evolving requirements of India require a strong partnership with a compliance firm, 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 MD14, Medical Device Rules, 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 to ensure that all regulations are met. We provide comprehensive support for registration, including handling notified devices and ensuring timely approval time. Morulaa is your trusted partner for navigating the complexities of the India regulatory landscape, ensuring smooth market access and compliance with all CDSCO requirements