Menu
Steps and Documents required for medical device registration in India
In India, the regulation of medical devices and in vitro diagnostics (IVDs) is managed by the Central Drug Standard Control Organization (CDSCO) via the Sugam Application India platform. 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 in India under Class A, B, C, or D for importing the devices.
The Authorized Indian Agent acts as the Legal Importer as per CDSCO medical device regulations in India and is responsible for submitting necessary documents when applying. To obtain this registration, the Importer or Authorized Indian Agent must submit Form MD14 via the SUGAM portal by following the MD14 checklist India. Upon the CDSCO approval, an MD15 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) via the Sugam Application India platform. 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 in India under Class A, B, C, or D for importing the devices.
The Authorized Indian Agent acts as the Legal Importer as per CDSCO medical device regulations in India and is responsible for submitting necessary documents when applying. To obtain this registration, the Importer or Authorized Indian Agent must submit Form MD14 via the SUGAM portal by following the MD14 checklist India. Upon the CDSCO approval, an MD15 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 Checklist (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 MD14 application that are needed for medical device registration process India with the CDSCO includes – (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. Ensure all elements outlined in the MD14 checklist India are included, which covers detailed information on the device’s design, manufacturing processes, and quality control measures needed for the medical device registration process India
The Predicate Table submitted as a part of the CDSCO import license form MD14 outlines medical devices that are substantially equivalent to your device This should be in alignment with the MD14 checklist India to ensure accuracy and completeness. 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 under CDSCO medical device regulations . 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 India.
The remaining required MD14 documents India by the CDSCO for the medical device registration process is typically available if the manufacturer has approval from a Global Harmonization Task Force (GHTF) country. Ensure compliance by following the MD14 checklist India. These documents, when applying, are crucial for ensuring compliance. The table on the left lists the requirements based on the classification, allowing manufacturers to leverage their existing documents when applying for the MD15 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 Checklist (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 MD14 application that are needed for medical device registration process India with the CDSCO includes – (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. Ensure all elements outlined in the MD14 checklist India are included, which covers detailed information on the device’s design, manufacturing processes, and quality control measures needed for the medical device registration process India
The Predicate Table submitted as a part of the CDSCO import license form MD14 outlines medical devices that are substantially equivalent to your device This should be in alignment with the MD14 checklist India to ensure accuracy and completeness. 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 under CDSCO medical device regulations . 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 India.
The remaining required MD14 documents in India by the CDSCO for the medical device registration process is typically available if the manufacturer has approval from a Global Harmonization Task Force (GHTF) country. Ensure compliance by following the MD14 checklist India. These documents, when applying, are crucial for ensuring compliance. The table on the left lists the requirements based on the classification, allowing manufacturers to leverage their existing documents when applying for the MD15 Import License.
This legal document grants the Agent the authority to act on behalf of the foreign manufacturer to apply for the MD14 and in all matters related to the import of the medical device and apply for medical device registration in India under CDSCO Medical device regulations in India
The SUGAM portal in India is the online system used by the Central Drugs Standard Control Organization (CDSCO) for for India Authorized Importers submission and processing of MD14 documents India related to medical device registration process India
The list of documents to upload via Sugam Application India includes technical, clinical, preclinical, and quality management systems documents information required for regulatory review by the CDSCO to access and grant approval in India for importing into the Country through medical device regulatory importer services India
The CDSCO fees are determined based on the classification of the medical device and must be paid to proceed with the MD14 application review as part of the CDSCO medical device approval process India.
The CDSCO may request additional information or clarification during the MD14 review process. Adhering to the MD14 checklist India ensures that all necessary documents and information are available for a timely response to avoid delays in documentation and review process following CDSCO Medical device regulations India
The MDAC team of the CDSCO assesses the safety and efficacy of novel medical devices. Adhering to the MD14 checklist India can streamline this process by ensuring the required documents and compliance information are available. This helps obtain the MD-15 Import License India for the medical devices
Once the MD14 application is approved, the CDSCO issues the MD15 Import License, allowing the medical device to be legally imported into India and the medical device registration process is considered to be completed
With the CDSCO import license form MD14 in hand, the manufacturer can start shipping their medical devices to Indian distributors or directly to healthcare providers.
This legal document grants the Agent the authority to act on behalf of the foreign manufacturer to apply for the MD14 and in all matters related to the import of the medical device and apply for medical device registration in India under CDSCO Medical device regulations in India
The SUGAM portal in India is the online system used by the Central Drugs Standard Control Organization (CDSCO) for for India Authorized Importers submission and processing of MD14 documents India related to medical device registration process India
The list of documents to upload via Sugam Application India includes technical, clinical, preclinical, and quality management systems documents information required for regulatory review by the CDSCO to access and grant approval in India for importing into the Country through medical device regulatory importer services India
The CDSCO fees are determined based on the classification of the medical device and must be paid to proceed with the MD14 application review as part of the CDSCO medical device approval process India.
The CDSCO may request additional information or clarification during the MD14 review process. Adhering to the MD14 checklist India ensures that all necessary documents and information are available for a timely response to avoid delays in documentation and review process following CDSCO Medical device regulations India
The MDAC team of the CDSCO assesses the safety and efficacy of novel medical devices. Adhering to the MD14 checklist India can streamline this process by ensuring the required documents and compliance information are available. This helps obtain the MD-15 Import License India for the medical devices
Once the MD14 application is approved, the CDSCO issues the MD15 Import License, allowing the medical device to be legally imported into India and the medical device registration process is considered to be completed
With the CDSCO import license form MD14 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 Authorized 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 for the medical device registration process India.
As an independent importer, Morulaa efficiently manages inventory and ensures on-time registration via Sugam Application India for smooth operations. Whether launching products, transferring licenses, or changing distribution partners, appointing Morulaa as your Authorized Indian Agent minimizes supply chain disruptions and leverages our expertise in CDSCO medical device approval process India.
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 Authorized 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 for the medical device registration process India.
As an independent importer, Morulaa efficiently manages inventory and ensures on-time registration via Sugam Application India for smooth operations. Whether launching products, transferring licenses, or changing distribution partners, appointing Morulaa as your Authorized Indian Agent minimizes supply chain disruptions and leverages our expertise in CDSCO medical device approval process India .