Background For Medical Device Amendments:
Obtaining MD-15 Import License
CDSCO and DCGI Roles
This article details the Regulations and Guidelines to obtain the Form MD-15 Import License from the Central Drug Standard Control Organisation (CDSCO) under the Ministry of Health and Family Welfare (MoHFW) covering the Medical Device Rules, 2017 (MDR 2017 – DCGI). The history of Medical Device Regulations in India starts with the (CDSCO). The CDSCO is the Indian Advisory Body wherein all medical products are regulated by them. The responsibility lies with the Drugs Controller General of India (DCGI) under the CDSCO for Medical device approvals to obtain the MD-15 Import License in India.
The CDSCO is responsible for approval and regulation Drugs, Cosmetics, In Vitro Diagnostics (IVDs) and Medical Devices, control over the quality of Imported Devices, coordination of the activities of State Drug Control Organizations and providing expert advice with a view of bringing about the uniformity in the enforcement of the Drugs and Cosmetics Rules and Act in India. Manufacturers can leverage their medical device approvals in the United States of America (USA), United Kingdom (UK), Canada, European Union (EU), Australia or Japan for the Registration Process in India.
Drugs and Cosmetics Act 1940 and Rules, 1945 and Medical Device Rules, 2017:
The Drugs and Cosmetics Act, 1940 and Rules, 1945 corresponds to the Indian Medical Device Regulation of Importation, Manufacturing and Distribution of Drugs, Cosmetics, Medical Devices and In-Vitro Diagnostics (IVDs) in India by the CDSCO (DCGI). The most important objective of the CDSCO (DCGI) with this Act is to enforce that quality standards are adhered to and every device imported into India is protected. This article focuses on the regulation of Medical Devices Rules (MDR), 2017 enforced by the CDSCO (DCGI) in India.
There are two major pathways under the Medical device Rules, 2017 (MDR 2017) for the registration and approval of medical devices in India to obtain the Form MD-15 Import License
- Notified Medical Device Registration (Class A sterile/measuring, Class B, Class C, Class D)
- Non-Notified Medical Device Registration (Class A non-sterile and non-measuring)
1) Notified Medical Device Registration and Approval:
For Registration and Medical Device Approval under the Medical device Rules, 2017 (MDR 2017 – DCGI) to obtain the MD-15 Import License in India, previously 37 device categories have been listed as ‘Notified Medical Devices’ by the CDSCO. List of notified medical devices in India is given below. Now ALL medical devices in India except for the Class A – non-sterile and non-measuring come under the notified licensing regime with the CDSCO. Medical devices under the new regulation “ Medical Devices Rules (MDR 2017 – DCGI) ” are classified as per Global Harmonization Task Force (GHTF) based on associated risks,
i) Class A (low risk)
ii) Class B -(low moderate risk)
iii) Class C -(moderate high risk)
iv) Class D – (high risk)
| S.NO | Medical Device |
| 1 | Disposable Hypodermic Syringes |
| 2 | Disposable Hypodermic Needles |
| 3 | Disposable Perfusion Sets |
| 4 | Substances used for in vitro diagnosis including Blood Grouping Sera |
| 5 | Cardiac Stents |
| 6 | Drug Eluting Stents |
| 7 | Catheters |
| 8 | Intraocular Lenses |
| 9 | I.V. Cannulae |
| 10 | Bone Cements |
| 11 | Heart Valves |
| 12 | Scalp Vein Set |
| 13 | Orthopedic Implants |
| 14 | Internal Prosthetic Replacements |
| 15 | Ablation Devices |
| 16 | Ligatures, Sutures and Staplers |
| 17 | Intrauterine Devices (Cu-T) |
| 18 | Condoms |
| 19 | Tubal Rings |
| 20 | Surgical Dressings |
| 21 | Umbilical tapes |
| 22 | Blood/Blood Component Bags |
| 23 | Organ Preservative Solution* |
| 24 | Nebulizer (effective from 1 Jan.2021) |
| 25 | Blood Pressure Monitoring Device(effective from 1 Jan.2021) |
| 26 | Glucometer (effective from 1 Jan.2021) |
| 27 | Digital Thermometer (effective from 1 Jan.2021) |
| 28 | All implantable medical devices Equipment (effective from 1, April,2021) |
| 29 | CT Scan Equipment (effective from 1, April,2021) |
| 30 | MRI Equipment (effective from 1, April,2021 |
| 31 | Defibrillators (effective from 1, April,2021) |
| 32 | PET Equipment(effective from 1, April,2021) |
| 33 | X-Ray Machine (effective from 1, April,2021) |
| 34 | Dialysis Machine (effective from 1, April,2021) |
| 35 | Bone marrow cell separator (effective from 1, April,2021) |
| 36 | Disinfectants and insecticide specified in Medical Devices Rules, 2017 |
| 37 | Ultrasound equipment (effective from 1, November, 2020) |
*Please note: This list reflects only the previous 37 notified devices. Please contact us for a complete list of the regulated notified products with intended use and risk based classification.
The process to register the Notified medical devices under the Medical device Rules, 2017 (MDR 2017 – DCGI) to obtain the MD-15 Import License is –
Step 1 : Determination of Classification of Medical Device
When a manufacturer decides to get their products registered in India, he/she must review the First Schedule of the Medical Device Rules, 2017 and CDSCO’s published guidance on the long list of medical device risk classification prior to making a final determination of a device’s regulatory status and classification. Upon submitting the documents and approval, the CDSCO (DCGI) grants Form MD-15 import license. Form MD-15 can be used by the authorized license agent / importer at the customs stage to clear the goods into India.
Step 2 : Appointment of Indian Agent
Under the Medical device Rules, 2017 (MDR 2017), the manufacturer must appoint an India Authorized Agent to interact with the CDSCO on the SUGAM portal and facilitate the approval, Form MD-15 Import License from the CDSCO. The agent chosen must have a Wholesale Drug License (Forms 20B and 21B/21C) and/or Medical Device Registration Certificate for Sales and Distribution in Form MD-42. The Indian Agent will then be granted a Power Of Attorney to manage registration and importation in India after obtaining the Form MD-15 Import License from the CDSCO (DCGI).
Step 3 : Compilation of Documents for Medical Device Registration and Approval
The Medical device Rules, 2017 (MDR 2017) requires the manufacturer focus on compiling the following documents for Class A (sterile/measuring) for Form MD-15 Import License
- Plant registration certificat
- Free Sale Certificate (FSC) from the Country of Origin
- Quality Management System certificate or Full Quality Assurance certificate or
Production Quality Assurance certificate - Latest inspection or audit report
- Device description, intended use of the device, specification including variants
and accessories - Material of construction
- Working principle and use of a novel technology (if any)
- Labels, package inserts, Instruction for Use (IFU), user manual, wherever applicable
- Summary of any reported Serious Adverse Event in India or in any of the
countries where device is marketed - Site or plant master file as specified in Appendix I as of the MDR, 2017
- Essential principles checklist for general safety and performance requirement for the medical device (GSPR)
- Undertaking signed by the manufacturer stating that the manufacturing site is in
compliance with the provisions of the Fifth Schedule as per Medical device Rules, 2017 (MDR 2017) - Wholesale Drug License (Form 20B and Form 21B/21C) and/or Medical Device Registration Certification for Sales and Distribution in Form MD-42
- Constitutional details
- Power of Attorney (PoA)
- Legal Form MD-14
As per the Medical device Rules, 2017 (MDR 2017), the manufacturer will have to primarily have to focus on compiling the following documents for Class B, C and D for obtaining the medical device registration from the DCGl, Form MD-15 Import License
- Power of Attorney
- Free Sale Certificate (FSC) from the Country of Origin
- Free Sale Certificate (FSC) – USA, UK, EU, Canada, Japan, Australia
- ISO 13485 Certificatee
- Full Quality Assurance Certificate
- CE Design Certificate
- Declaration ofConformity
- Predicate Device Information / Substantial Equivalence Data
- Labels
- Instruction for Use (IFU)
- Batch release certificates for minimum 3 batches
- Audit Report
- Domestic Price list- Country of Origin
- Details of Product Recall
- Details of CAPA
- Post Market Surveillance Report
- Old Registration Certificate from CDSCO (if any)
- Adverse Events Globally
- Adverse Events India
- Quality Manual
- Technical File with all supporting reports as per the Fourth Schedule of India Medical Device Rules, 2017 (MDR, 2017)
- Form MD-14 application as filled on the SUGAM portal
Step 4: Submission
The next step is to file the application for registration / Import License in Form MD-14 on the CDSCO’s online medical device SUGAM portal. The authorized Indian agent needs to register itself with the CDSCO through the online medical device SUGAM portal. Once registered, the Indian agent can login and upload the documents. All the documents and reports must be in the English language as per the MDR, 2017 gazette notification. Submission will be complete by paying the CDSCO fees at actuals. Second Schedule of the India Medical device Rules, 2017 (MDR, 2017) list the requisite fees to be paid based on the risk classification.
Step 5 : Process and Timelines
The time period for obtaining Registration certificate of Medical Devices in India is 6-9 months. The clock stops once a query is raised and starts once responded to. New products without any strong predicates in India may take longer time and / or require a Special Expert Committee (SEC) review to obtain medical device approval for importation (Form MD-15) based on the recommendations by the CDSCO. After obtaining the import license in Form MD-15, the manufacturer can import into the country. Form MD-15 is valid for perpetuity unless it is 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.
Step 6 : Importation
The manufacturer can import their medical device into the country only via the Authorized Indian Agent using the import license in Form MD-15, Import/Export code and other documents as mandated by the customs authority at the Indian port.
2) Non-Notified Medical Device Registration:
Medical Device Amendments:
The CDSCO brought in a new amendment on 14th October 2022, wherein medical devices which are low risk (Class A) non-sterile and non-measuring, will be regulated under the non-notified medical device category of the MDR, 2017. These products are similar to the EU Class I (self certified) medical devices. Some examples of the medical device like Class I (non-sterile, non-measuring) instruments, apparatus, appliances and implants, irrespective of being used alone or in combination for various purposes like software, analysis, prevention, treatment, allaying of any disease, investigation, replacement or alteration or support of the anatomy among others, will be regulated under the legislation in India. These rules are called the Medical Devices (Sixth Amendment) Rules, 2022. This amendment comes under the gazette notification number G.S.R. 777(E) as published by the DCGI.
The process to obtain registration for non-notified devices under the medical device rules, 2017 (MDR, 2017) Amendments would be as follow-
Step 1 : Check Gazette Notification
When a manufacturer decides to get their product registration from CDSCO and obtain registration in India, he/she must review the CDSCO’s gazette notifications to understand if the product falls under a notified or non-notified category.
Step 2 : Appointment of Indian Agent
The manufacturer must appoint an Indian Agent who will handle the submission of documents through the CDSCO’s online medical device SUGAM portal and help obtain the registration number for a non-notified device.
Step 3 : Compilation of Documents
The importer will have to compile the following documents as per the Indian Medical Device Regulations and Guidelines,
Name of the company or firm or any other entity importing the medical device, specification and standards of the particular medical device
Details of medical device to be registered along with their components and accessories
Certificate of compliance with respect to ISO 13485 standard accredited by National Accreditation Board for Certification Bodies of India or International Accreditation Forum in respect of such medical device
Free Sale Certificate (FSC) from the Country of Origin
Undertaking signed by the manufacturer of the medical device that the proposed device is Class A non-sterile and non-measuring as per the First Schedule of the MDR, 2017, conforming to the essential principles / GSPR, and stating that the information provided by the applicant is true and authentic
Step 4 : Process and Verification
Once the documents are submitted in the SUGAM portal for Medical Device Approval, the CDSCO will provide a registration number for the particular medical device. The importer will then have to mention the registration number on the label of the medical device. The Central Licensing Authority, the CDSCO will verify the documents at any point of time and investigate quality or safety related failure or complaints. If the manufacturer fails to comply with the provision of the new rules, the CDSCO may cancel the registration number or suspend it for a period of time.
Step 5 : Importation
The manufacturer can import their device into the country only via the Authorized Indian Agent after obtaining the Medical Device Approval (Registration Number from the Online SUGAM Portal) from the CDSCO.
How can Morulaa Help:
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