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Documents Required : Medical Products Regulations & Compliance Parter
In India, the regulation of medical devices and in vitro diagnostics (IVDs) is managed by the Central Drug Standard Control Organization (CDSCO). The Medical Device Rules, 2017, effective from January 1, 2018, initially covered 37 specific devices but now require all devices and IVDs to obtain an Importer License under Class A, B, C, or D for importing the medical devices into India.
The Authorized Indian Agent acts as the Legal Importer as per CDSCO Indian regulation for medical devices. To obtain this registration, the Importer or Authorised Indian Agent must submit Form MD-14 via the SUGAM portal. Upon the CDSCO approval, an MD-15 Import License is granted, officially recognizing the agent as the Importer in India.
In India, the regulation of medical devices and in vitro diagnostics (IVDs) is managed by the Central Drug Standard Control Organization (CDSCO). The Medical Device Rules, 2017, effective from January 1, 2018, initially covered 37 specific devices but now require all devices and IVDs to obtain an Importer License under Class A, B, C, or D for importing the medical devices into India.
The Authorized Indian Agent acts as the Legal Importer as per CDSCO Indian regulation for medical devices. To obtain this registration, the Importer or Authorised Indian Agent must submit Form MD-14 via the SUGAM portal. Upon the CDSCO approval, an MD-15 Import License is granted, officially recognizing the agent as the Importer in India.
Documents |
Class A Self Notified |
Class A Notified |
Class B, C, D Devices |
|---|---|---|---|
|
Free Sale Certificate from Country of Origin |
YES |
YES |
YES |
|
Other Certificates (Free Sale Certificate from GHTF Country, ISO 13485, CE / EC Design Certificates) |
NO |
YES |
YES |
|
Company Document (DOC, Audit Report, Plant Registration Certificate, Quality Manual, Device Technical File, Essential Principles Checklist, Post Marketing Surveillance data) |
NO |
YES |
YES |
|
Additional Data (BRC / COA, Device Design, Verification, Risk, Biocompatibility, Stability, Software etc.) |
NO |
NO |
YES |
|
Scientific Data (Preclinical Animal Studies, Clinical Studies and Published Papers) |
NO |
NO |
YES |
The two important regulatory documents in MD-14 application that are needed for medical device Indian registrations with the CDSCO include – (1) Device Master File and (2) Predicate Table
The Device Master File by the CDSCO, equivalent to the Device Technical File of the medical device is an important part of the registration document, includes detailed information on the device’s design, manufacturing processes, and quality control measures.
The Predicate Table submitted as a part of the MD-14 outlines medical devices that are substantially equivalent to your device, as detailed in the Clinical Evaluation Report. We need to keep in mind that a substantially equivalent predicate are ones where the medical device is similar in material, intended use and design to the registering one.
If the product does not have predicate device available in India then we should apply in FORM MD 26 to meet regulatory compliance. A special investigation team set by CDSCO reviews this in all aspects specifically focusing on clinical investigation carried out by the manufacturers prior to granting medical device approval in India.
The remaining required MD-14 documents for registration in India by the CDSCO for medical devices are typically available if the manufacturer has approval from a Global Harmonization Task Force (GHTF) country. The table on the left lists the requirements based on the classification, allowing manufacturers to leverage their existing documents when applying for the MD-15 Import License.
Documents |
Class A Self Notified |
Class A Notified |
Class B, C, D Devices |
|---|---|---|---|
|
Free Sale Certificate from Country of Origin |
YES |
YES |
YES |
|
Other Certificates (Free Sale Certificate from GHTF Country, ISO 13485, CE / EC Design Certificates) |
NO |
YES |
YES |
|
Company Document (DOC, Audit Report, Plant Registration Certificate, Quality Manual, Device Technical File, Essential Principles Checklist, Post Marketing Surveillance data) |
NO |
YES |
YES |
|
Additional Data (BRC / COA, Device Design, Verification, Risk, Biocompatibility, Stability, Software etc.) |
NO |
NO |
YES |
|
Scientific Data (Preclinical Animal Studies, Clinical Studies and Published Papers) |
NO |
NO |
YES |
The two important regulatory documents in MD-14 application that are needed for medical device Indian registrations with the CDSCO include – (1) Device Master File and (2) Predicate Table
The Device Master File by the CDSCO, equivalent to the Device Technical File of the medical device is an important part of the registration document, includes detailed information on the device’s design, manufacturing processes, and quality control measures.
The Predicate Table submitted as a part of the MD-14 outlines medical devices that are substantially equivalent to your device, as detailed in the Clinical Evaluation Report. We need to keep in mind that a substantially equivalent predicate are ones where the medical device is similar in material, intended use and design to the registering one.
If the product does not have predicate device available in India then we should apply in FORM MD 26 to meet regulatory compliance. A special investigation team set by CDSCO reviews this in all aspects specifically focusing on clinical investigation carried out by the manufacturers prior to granting medical device approval in India.
The remaining required MD-14 documents for registration in India by the CDSCO for medical devices are typically available if the manufacturer has approval from a Global Harmonization Task Force (GHTF) country. The table on the left lists the requirements based on the classification, allowing manufacturers to leverage their existing documents when applying for the MD-15 Import License.
This legal document grants the Indian Agent the authority to act on behalf of the foreign manufacturer to apply for the MD-14 and in all matters related to the import of the medical device and apply for medical device registration in India
The SUGAM portal in India is the online system used by the Central Drugs Standard Control Organization (CDSCO) for submission and processing of MD-14 documents related to medical device registrations.
These MD-14 documents include technical, clinical, predicate, quality management system information required for regulatory review by the CDSCO to access and grant approval in India for importing into the Country
The CDSCO fees are determined based on the classification of the medical device and must be paid to proceed with the MD-14 application review.
The CDSCO may request additional information or clarification during the MD-14 review process, and timely responses are crucial to avoid delays in documentation and review process
The MDAC team of the CDSCO assesses the safety and efficacy of novel medical devices, providing recommendations for their approval should the predicate not match. This helps obtain the MD-15 Import License in India for the medical devices
Once the MD-14 application is approved, the CDSCO issues the MD-15 Import License, allowing the medical device to be legally imported into India and the registration process is considered to be complete
With the CDSCO Import License in hand, the manufacturer can start shipping their medical devices to Indian distributors or directly to healthcare providers.
This legal document grants the Indian Agent the authority to act on behalf of the foreign manufacturer to apply for the MD-14 and in all matters related to the import of the medical device and apply for medical device registration in India
The SUGAM portal in India is the online system used by the Central Drugs Standard Control Organization (CDSCO) for submission and processing of MD-14 documents related to medical device registrations.
These MD-14 documents include technical, clinical, predicate, quality management system information required for regulatory review by the CDSCO to access and grant approval in India for importing into the Country
The CDSCO fees are determined based on the classification of the medical device and must be paid to proceed with the MD-14 application review.
The CDSCO may request additional information or clarification during the MD-14 review process, and timely responses are crucial to avoid delays in documentation and review process
The MDAC team of the CDSCO assesses the safety and efficacy of novel medical devices, providing recommendations for their approval should the predicate not match. This helps obtain the MD-15 Import License in India for the medical devices
Once the MD-14 application is approved, the CDSCO issues the MD-15 Import License, allowing the medical device to be legally imported into India and the registration process is considered to be complete
With the CDSCO Import License in hand, the manufacturer can start shipping their medical devices to Indian distributors or directly to healthcare providers.
Importing medical devices in India requires a knowledgeable firm experienced with the CDSCO’s Medical Device Rules, 2017, and Indian Customs. Choosing Morulaa gives you access to India’s largest Independent Importer. Depending on your product type, additional licenses like the Electronic Waste Disposal License, BIS Certificate for batteries, PC & PNDT certificate for ultrasound devices, and Atomic Energy Regulatory Board certification for X-ray products may be needed.
An Independent Importer simplifies labeling, manages inventory efficiently, and ensures last-mile delivery across India. Whether launching products, transferring licenses, or changing distribution partners, appointing Morulaa as your Authorized Indian Agent minimizes supply chain disruptions and leverages our expertise.
Importing medical devices in India requires a knowledgeable firm experienced with the CDSCO’s Medical Device Rules, 2017, and Indian Customs. Choosing Morulaa gives you access to India’s largest Independent Importer. Depending on your product type, additional licenses like the Electronic Waste Disposal License, BIS Certificate for batteries, PC & PNDT certificate for ultrasound devices, and Atomic Energy Regulatory Board certification for X-ray products may be needed.
An Independent Importer simplifies labeling, manages inventory efficiently, and ensures last-mile delivery across India. Whether launching products, transferring licenses, or changing distribution partners, appointing Morulaa as your Authorized Indian Agent minimizes supply chain disruptions and leverages our expertise.