Q&A India
A Guide to Medical Device Registration in India: Frequently Asked Questions
Medical Device Registration in India is regulated by the Central Drug Standard Organisation (CDSCO) under the Medical Device Rules, 2017 and the Drugs and Cosmetics Act of 1945. This article comes with some frequently asked questions for registering your device in India.
Medical Device Import Licensing Frequently Asked Questions
Medical Device Import Licensing Frequently Asked Questions
In India, registration must be done through an Independent Authorized Agent or India authorized importer holding either a valid Wholesale Drug License in Form 20B and 21B or Medical Device Registration Certificate in Form MD-42. You have the option to set up your own office if you prefer to register directly. However, partnering with an India Authorized Importer or Independent Authorized Agent, such as Morulaa, allows you to stay abreast and maintain the ever changing compliances in the Indian Healthcare market.
The manufacturer needs to obtain the Import License (Form MD-15) to start selling in India. An Independent Authorized Agent needs to be appointed who can apply on behalf of the manufacturer in India.
In India, a medical device registration license is valid for perpetuity unless its canceled or surrendered. However, it is essential to renew the license every five years by depositing license retention fee to ensure continued compliance with regulatory requirements. A late fee of two per cent will be applicable if the due date is crossed.
The time frame remains the same unless it is a Class A non-sterile, non-measuring device. Class A non-sterile, non-measuring devices may have an automatic approval route through self-declaration on the MD-14 form.
As per current regulations, it is mandatory to pay the government fees every five years and submit retention documents like renewed certificates, any changes made to the device or manufacturing site over the last 5 years and any reported recalls or adverse events in India.
Yes, you need to register with the Indian FDA (CDSCO). However, having approval from a GHTF (Global Harmonization Task Force) country supports your application. The documentation is similar to what you would submit for an EU MDR application or US-FDA such as ISO Certificate, CE Design, Free Sale Certificate, Quality Manual, Complete Technical File with supporting reports as mandated in the Fourth Schedule of the Indian Medical Device Rules (MDR) 2017.
| Class | Fee | US $ |
|---|---|---|
| Class A | (a) one site; and (b) Each distinct medical device. | $1000 $50 |
| Class B | (a) one site; and (b) Each distinct medical device. | $2000 $1000 |
| Class C and Class D | (a) one site; and (b) Each distinct medical device. | $3000 $1500 |
First Schedule of Indian MDR, 2017 lists out the parameters for determining the classification of your medical device. The classification is governed by the intended purpose of the device. In most cases, risk classification is similar to the EU MDR classification. Hence, Class I corresponds to Class A, Class IIa to Class B, Class IIb to Class C, and Class III to Class D. However, this should be verified against the published guidelines, and the CDSCO may request a different classification upon reviewing your files.
To further help the manufacturer’s determine the class of the device, CDSCO has identified and posted a comprehensive list of medical devices (including components and accessories) with their intended purpose and recommended risk classification. Please contact us if you wish to receive this document.
If your product has approval from a GHTF Country and a strong predicate (equivalent product) actively selling in India, typically clinical trials are not required. However, if either of these two conditions are not met, you get an opportunity to present your clinical studies, market data in front of a panel of experts who will determine whether to grant approval or request local trials. Morulaa has developed a Regulatory Pathway Analysis Tool which will help you determine the pathway and licenses required for India. Please contact us if you wish to learn more about this.
Only those accessories or components defined in the Device Master File as part of the main device(s) and mentioned in its Instructions for Use (IFU) need to be listed. These said accessories and components should have a valid Free Sale Certificate in the country of origin.
In India, registration must be done through an Independent Authorized Agent or India authorized importer holding either a valid Wholesale Drug License in Form 20B and 21B or Medical Device Registration Certificate in Form MD-42. You have the option to set up your own office if you prefer to register directly. However, partnering with an India Authorized Importer or Independent Authorized Agent, such as Morulaa, allows you to stay abreast and maintain the ever changing compliances in the Indian Healthcare market.
The manufacturer needs to obtain the Import License (Form MD-15) to start selling in India. An Independent Authorized Agent needs to be appointed who can apply on behalf of the manufacturer in India.
In India, a medical device registration license is valid for perpetuity unless its canceled or surrendered. However, it is essential to renew the license every five years by depositing license retention fee to ensure continued compliance with regulatory requirements. A late fee of two per cent will be applicable if the due date is crossed.
The time frame remains the same unless it is a Class A non-sterile, non-measuring device. Class A non-sterile, non-measuring devices may have an automatic approval route through self-declaration on the MD-14 form.
As per current regulations, it is mandatory to pay the government fees every five years and submit retention documents like renewed certificates, any changes made to the device or manufacturing site over the last 5 years and any reported recalls or adverse events in India.
Yes, you need to register with the Indian FDA (CDSCO). However, having approval from a GHTF (Global Harmonization Task Force) country supports your application. The documentation is similar to what you would submit for an EU MDR application or US-FDA such as ISO Certificate, CE Design, Free Sale Certificate, Quality Manual, Complete Technical File with supporting reports as mandated in the Fourth Schedule of the Indian Medical Device Rules (MDR) 2017.
| Class | Fee | US $ |
|---|---|---|
| Class A | (a) one site; and (b) Each distinct medical device. | $1000 $50 |
| Class B | (a) one site; and (b) Each distinct medical device. | $2000 $1000 |
| Class C and Class D | (a) one site; and (b) Each distinct medical device. | $3000 $1500 |
First Schedule of Indian MDR, 2017 lists out the parameters for determining the classification of your medical device. The classification is governed by the intended purpose of the device. In most cases, risk classification is similar to the EU MDR classification. Hence, Class I corresponds to Class A, Class IIa to Class B, Class IIb to Class C, and Class III to Class D. However, this should be verified against the published guidelines, and the CDSCO may request a different classification upon reviewing your files.
To further help the manufacturer’s determine the class of the device, CDSCO has identified and posted a comprehensive list of medical devices (including components and accessories) with their intended purpose and recommended risk classification. Please contact us if you wish to receive this document.
If your product has approval from a GHTF Country and a strong predicate (equivalent product) actively selling in India, typically clinical trials are not required. However, if either of these two conditions are not met, you get an opportunity to present your clinical studies, market data in front of a panel of experts who will determine whether to grant approval or request local trials. Morulaa has developed a Regulatory Pathway Analysis Tool which will help you determine the pathway and licenses required for India. Please contact us if you wish to learn more about this.
Only those accessories or components defined in the Device Master File as part of the main device(s) and mentioned in its Instructions for Use (IFU) need to be listed. These said accessories and components should have a valid Free Sale Certificate in the country of origin.
Document Preparation and Submission of Form MD-14 Frequently Asked Questions
Document Preparation and Submission of Form MD-14 Frequently Asked Questions
In India, medical devices are grouped into four categories - single, group, family and system. The grouping is determined based on the intended use, device design and manufacturing, material of construction, device risk classification and how it is sold (individual or packaged).
Yes, creating a Device Master File (DMF) using a technical file from another GHTF country can reduce the time required for registration. We have in-house experts who are trained in EU MDD/MDR, FDA and TGA who can review the documentations and prepare a complete DMF based on your data.
Applications and supporting documents need to be submitted in English for registration on the CDSCO online SUGAM portal.
Yes, an FSC (Free Sale Certificate) from the country of origin is required to register a medical device in India. If you are from a non-GHTF country, a Free Sale Certificate from either USA, EU, UK, Canada, Australia or Japan is recommended to expedite the approval process with minimal queries from the CDSCO.
As per Indian MDR, 2017, the CDSCO may inspect the manufacturing site either by itself or a third party body. The fee and the expenditure for the same will be borne by the manufacturer. However, in our experience of working with the CDSCO for medical devices since 2009, no audits of the legal or actual manufacturer has been conducted. A valid ISO 13485 certificate from the manufacturer factory and a Plant Master File (PMF) are considered sufficient for compliance.
A Plant Master File is based on a Quality Manual and is a straightforward document. Once all relevant documents are provided to Morulaa, we can create the Plant Master File within 2-3 working days.
The time required to create a Device Master File depends on the completeness of the documents provided by the client. Once all necessary documents are submitted to Morulaa, we can complete the creation of the Device Master File within 2-3 working days.
Yes, a client can register the same label design in India, provided that the details of the country of origin and India importer details are included on the label along with all the requirements as listed in Chapter VI of the Indian MDR, 2017.
In India, medical devices are grouped into four categories - single, group, family and system. The grouping is determined based on the intended use, device design and manufacturing, material of construction, device risk classification and how it is sold (individual or packaged).
Yes, creating a Device Master File (DMF) using a technical file from another GHTF country can reduce the time required for registration. We have in-house experts who are trained in EU MDD/MDR, FDA and TGA who can review the documentations and prepare a complete DMF based on your data.
Applications and supporting documents need to be submitted in English for registration on the CDSCO online SUGAM portal.
Yes, an FSC (Free Sale Certificate) from the country of origin is required to register a medical device in India. If you are from a non-GHTF country, a Free Sale Certificate from either USA, EU, UK, Canada, Australia or Japan is recommended to expedite the approval process with minimal queries from the CDSCO.
As per Indian MDR, 2017, the CDSCO may inspect the manufacturing site either by itself or a third party body. The fee and the expenditure for the same will be borne by the manufacturer. However, in our experience of working with the CDSCO for medical devices since 2009, no audits of the legal or actual manufacturer has been conducted. A valid ISO 13485 certificate from the manufacturer factory and a Plant Master File (PMF) are considered sufficient for compliance.
A Plant Master File is based on a Quality Manual and is a straightforward document. Once all relevant documents are provided to Morulaa, we can create the Plant Master File within 2-3 working days.
The time required to create a Device Master File depends on the completeness of the documents provided by the client. Once all necessary documents are submitted to Morulaa, we can complete the creation of the Device Master File within 2-3 working days.
Yes, a client can register the same label design in India, provided that the details of the country of origin and India importer details are included on the label along with all the requirements as listed in Chapter VI of the Indian MDR, 2017.
Importation and Distribution Frequently Asked Questions
Importation and Distribution Frequently Asked Questions
Yes, clients can ship products directly to multiple distributors while using Morulaa as their India authorized importer. However, there are certain prerequisites that we usually discuss with the manufacturer once the products are approved to ensure smooth distribution and compliance. Our aim is to give you freedom and flexibility in choosing your network and sales strategy for your device in India.
Yes, a separate importer agreement between the manufacturer and importer is required to provide importation services for the device in India.
The importation support services include:
- Coordination of customs clearance and
- Management of regulatory documentation and
- Handling import duties
Yes, the Medical Device Registration Certificate Holder also serves as the India authorized Importer. Goods can be sent using a Bill-to-Ship model, with the shipping address being that of your distributor. Morulaa offers a seamless experience to help maintain a smooth supply chain for your medical devices in India as your Independent Importer or Independent Authorized Agent.
Yes, clients can ship products directly to multiple distributors while using Morulaa as their India authorized importer. However, there are certain prerequisites that we usually discuss with the manufacturer once the products are approved to ensure smooth distribution and compliance. Our aim is to give you freedom and flexibility in choosing your network and sales strategy for your device in India.
Yes, a separate importer agreement between the manufacturer and importer is required to provide importation services for the device in India.
The importation support services include:
- Coordination of customs clearance and
- Management of regulatory documentation and
- Handling import duties
Yes, the Medical Device Registration Certificate Holder also serves as the India authorized Importer. Goods can be sent using a Bill-to-Ship model, with the shipping address being that of your distributor. Morulaa offers a seamless experience to help maintain a smooth supply chain for your medical devices in India as your Independent Importer or Independent Authorized Agent.