Medical Devices
Regulatory Services
At Regalliance, our team brings extensive collective experience in regulatory affairs. Over the years, our experts have supported breakthrough medical device technology approvals by guiding companies across India and globally through medical devices registration in india. We provide a clear, structured regulatory pathway to ensure the successful launch of products in full compliance with the Medical Device Rules in India.
Medical Devices Regulatory Services
At Regallience, our team brings extensive collective experience in regulatory affairs. Over the years, our experts have supported breakthrough medical device technology approvals by guiding companies across India and globally through medical devices registration in india. We provide a clear, structured regulatory pathway to ensure the successful launch of products in full compliance with the Medical Device Rules in India.
The Legal Definition of Medical Devices
1. Under the Medical Devices Rules, 2017
As per the Medical Devices Rules, 2017, a Medical Device means:
In Vitro Diagnostics & Surgical Materials: Substances used for in vitro diagnosis, surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, and blood or blood component collection bags (with or without anticoagulant) covered under sub-clause (i).
Contraceptives & Disinfectants: Substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants, and insecticides notified in the Official Gazette under sub-clause (ii).
Notified Devices: Devices notified from time to time under sub-clause (iv) of clause (b) of Section 3 of the Drugs and Cosmetics Act, 1940.
Note: There are 37 categories of Notified Medical Devices under these rules.
2. Expanded Definition for “New Notified Medical Devices”
On February 11, 2020, the Ministry of Health and Family Welfare (CDSCO) further elaborated the definition to cover all “New Notified Medical Devices”.
Under this broader framework, a medical device includes:
Any instrument, apparatus, appliance, implant, material, or other article—whether used alone or in combination, including software or an accessory—intended by its manufacturer to be used specifically for human beings or animals, which does not achieve its primary intended action in or on the human body or animals by pharmacological, immunological, or metabolic means (but which may assist in its intended function by such means), for one or more of the specific purposes of:
Diagnosis, prevention, monitoring, treatment, or alleviation of any disease or disorder.
Diagnosis, monitoring, treatment, alleviation, or assistance for any injury or disability.
Investigation, replacement, modification, or support of the anatomy or of a physiological process.
Supporting or sustaining life.
Disinfection of medical devices.
Control of conception.
This expanded definition ensures that all medical devices not previously notified prior to February 11, 2020 (i.e., beyond the original 37 categories) are now fully regulated under Indian law.
Why Are Medical Devices Defined as “Drugs”?
Medical devices in India are regulated under the overarching framework of the Drugs and Cosmetics Act, 1940 (DCA). Within the DCA, medical devices are legally notified as “drugs” first so they fall under the statutory purview of the Act.
Because the Medical Devices Rules, 2017 were framed directly under the authority of the DCA, classifying medical devices as drugs provides the statutory backing required to regulate them under the Medical Devices Rules, 2017.
Introduction to Medical Devices Regulations in India
Historically, the medical devices sector in India operated under minimal regulatory oversight. With limited centralized quality control systems, patients often faced risks regarding product safety, structural efficacy, and consistent access to quality medical technologies.
Recognizing these challenges, the Ministry of Health and Family Welfare (MoHFW), Government of India, introduced frameworks to bring domestic manufacturers and international suppliers under standardized regulatory oversight. The oversight is managed by the Central Drugs Standard Control Organization (CDSCO).
Key Regulatory Milestones
Strategic Guidance and Registration Solutions by Regallience
At Regallience, we guide companies through medical devices registration in india. We help both domestic manufacturers and global brands map out compliant pathways under the Medical Devices Rules, 2017.
Risk-Based Classification & Regulatory Pathways
Under CDSCO guidelines, medical devices are categorized into four distinct risk classes, determining their statutory approval pathway:
Class A
Risk Level: Low Risk
Class B
Risk Level: Low-Moderate Risk
Class C
Risk Level: Moderate-High Risk
Class D
Risk Level: High Risk
Class A
Risk Level: Low Risk
Domestic Manufacturing Authority: State Licensing Authority (Form MD-3 / MD-5)
Statutory Import Gateway:
CDSCO Central Authority (Form MD-14 / MD-15)
Class B
Risk Level: Low-Moderate Risk
Domestic Manufacturing Authority: State Licensing Authority (Form MD-3 / MD-5)
Statutory Import Gateway: CDSCO Central Authority (Form MD-14 / MD-15)
Class C
Risk Level: Moderate-High Risk
Domestic Manufacturing Authority: CDSCO Central Authority (Form MD-7 / MD-9)
Statutory Import Gateway: CDSCO Central Authority (Form MD-14 / MD-15)
Class D
Risk Level: High Risk
Domestic Manufacturing Authority: CDSCO Central Authority (Form MD-7 / MD-9))
Statutory Import Gateway: CDSCO Central Authority (Form MD-14 / MD-15)
Regulatory Timeline and Notified Categories for Medical Devices Registration in India
The New Medical Devices Regulations came into effect in January 2018, establishing a distinct regulatory identity for medical devices and in vitro diagnostic devices. To ensure patient safety, devices were delinked from drugs, and the Medical Devices Rules were formulated to check the quality, efficacy, and performance of products sold across the country.
At Regallience, our experts assist global and domestic companies in navigating medical devices registration in india, ensuring full alignment with CDSCO notifications and statutory timelines.
Historical Regulatory Timeline of Notified Medical Devices
Below is the chronological sequence of official government notifications expanding the scope of regulated medical devices:
Master List: 37 Notified Medical Device Categories
The following 37 categories represent the core list of notified medical devices under CDSCO regulation:
| S.No. | Notified Category | S.No. | Notified Category |
| 1 | Disposable Hypodermic Syringes | 20 | Surgical Dressings |
| 2 | Disposable Hypodermic Needles | 21 | Umbilical Tapes |
| 3 | Disposable Perfusion Sets | 22 | Blood / Blood Component Collection Bags |
| 4 | In Vitro Diagnostics (including Blood Grouping Sera) | 23 | Organ Preservative Solution |
| 5 | Cardiac Stents | 24 | Nebulizer |
| 6 | Drug Eluting Stents | 25 | Blood Pressure Monitoring Device |
| 7 | Catheters | 26 | Glucometer |
| 8 | Intra Ocular Lenses | 27 | Digital Thermometer |
| 9 | I.V. Cannulae | 28 | All Implantable Medical Devices Equipment |
| 10 | Bone Cements | 29 | CT Scan Equipment |
| 11 | Heart Valves | 30 | MRI Equipment |
| 12 | Scalp Vein Set | 31 | Defibrillators |
| 13 | Orthopedic Implants | 32 | PET Equipment |
| 14 | Internal Prosthetic Replacements | 33 | X-Ray Machine |
| 15 | Ablation Devices | 34 | Dialysis Machine |
| 16 | Ligatures, Sutures, and Staplers | 35 | Bone Marrow Cell Separator |
| 17 | Intra Uterine Devices (Cu-T) | 36 | Disinfectants & Insecticides (MDR 2017) |
| 18 | Condoms | 37 | Ultrasound Equipment |
| 19 | Tubal Rings |
| S.No. | Notified Medical Device Category |
| 1 | Disposable Hypodermic Syringes |
| 2 | Disposable Hypodermic Needles |
| 3 | Disposable Perfusion Sets |
| 4 | In Vitro Diagnostics (including Blood Grouping Sera) |
| 5 | Cardiac Stents |
| 6 | Drug Eluting Stents |
| 7 | Catheters |
| 8 | Intra Ocular 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 | Intra Uterine Devices (Cu-T) |
| 18 | Condoms |
| 19 | Tubal Rings |
| 20 | Surgical Dressings |
| 21 | Umbilical Tapes |
| 22 | Blood / Blood Component Collection Bags |
| 23 | Organ Preservative Solution |
| 24 | Nebulizer |
| 25 | Blood Pressure Monitoring Device |
| 26 | Glucometer |
| 27 | Digital Thermometer |
| 28 | All Implantable Medical Devices Equipment |
| 29 | CT Scan Equipment |
| 30 | MRI Equipment |
| 31 | Defibrillators |
| 32 | PET Equipment |
| 33 | X-Ray Machine |
| 34 | Dialysis Machine |
| 35 | Bone Marrow Cell Separator |
| 36 | Disinfectants & Insecticides (MDR 2017) |
| 37 | Ultrasound Equipment |
How Regallience Supports Your Registration Strategy?
Navigating these category definitions and notification dates is essential for determining your exact compliance pathway under the CDSCO SUGAM portal. Regallience manages dossier structuring, classification verification, and end-to-end filing to ensure seamless market authorization for your medical devices in India.
Overview of Licenses, Classes, and Government Fees for Medical Devices Registration in India
Under the Medical Devices Rules, 2017, regulated by the Central Drugs Standard Control Organization (CDSCO) and State Licensing Authorities (SLA), obtaining market authorization for medical devices and in vitro diagnostics in India requires filing specific application forms based on the device’s risk classification and intended purpose.
At Regallience, we assist manufacturers and importers in navigating these regulatory frameworks for medical devices registration in india. Below is the master matrix detailing application forms, granted certificates, risk categories, authority jurisdictions, and official government statutory fees:
Master Regulatory Fee Structure & License Breakdown
| S.No. | Application Form | Approval / License Form | Risk Class | Governing Authority | Government Statutory Fees |
| 1 | MD-1 (Application for Registration of Notified Body) | MD-2 (Certificate of Registration for Notified Body) | N/A | CDSCO | ₹25,000 |
| 2 | MD-3 (Application for License to Manufacture) | MD-5 (License to Manufacture) | Class A & B | SLA | ₹5,000 (Plant) + ₹500 per product |
| 3 | MD-4 (Application for Loan License to Manufacture) | MD-6 (Loan License to Manufacture) | Class A & B | SLA | ₹5,000 (Plant) + ₹500 per product |
| 4 | MD-7 (Application for License to Manufacture) | MD-9 (License to Manufacture) | Class C & D | CDSCO | ₹50,000 (Plant) + ₹1,000 per product |
| 5 | MD-8 (Application for Loan License to Manufacture) | MD-10 (Loan License to Manufacture) | Class C & D | CDSCO | ₹50,000 (Plant) + ₹1,000 per product |
| 6 | MD-11 (Form for Audit/Inspection Book Maintenance) | N/A | N/A | CDSCO / SLA | $6,000 |
| 7 | MD-12 (Application for Manufacturing Test License for Clinical Investigation / Evaluation) | MD-13 (Test License to Manufacture for Investigation / Evaluation) | Class A, B, C, D | CDSCO | ₹500 |
| 8 | MD-14 (Import License Application for Non-IVD) | MD-15 (Import License Granted) | Class A | CDSCO | $1,000 (Plant) + $50 per product |
| 9 | MD-14 (Import License Application for Non-IVD) | MD-15 (Import License Granted) | Class B | CDSCO | $2,000 (Plant) + $1,000 per product |
| 10 | MD-14 (Import License Application for Non-IVD) | MD-15 (Import License Granted) | Class C & D | CDSCO | $3,000 (Plant) + $1,500 per product |
| 11 | MD-14 (Import License Application for IVD) | MD-15 (Import License Granted for IVD) | Class A & B (In Vitro) | CDSCO | $1,000 (Plant) + $10 per product |
| 12 | MD-14 (Import License Application for IVD) | MD-15 (Import License Granted for IVD) | Class C & D (In Vitro) | CDSCO | $3,000 (Plant) + $500 per product |
| 13 | MD-16 (Application for Test License to Import for Evaluation / Investigation) | MD-17 (Test License to Import for Evaluation / Investigation) | Class A, B, C, D | CDSCO | $100 |
| 14 | MD-18 (Application to Import Investigational Devices for Govt Hospitals / Institutions) | MD-19 (License to Import Investigational Devices for Govt Hospitals) | Class A, B, C, D | CDSCO | ₹500 |
| 15 | MD-20 (Application for Permission to Import Small Quantity for Personal Use) | MD-21 (Permission to Import Small Quantity for Personal Use) | Class A, B, C, D | CDSCO | No Fee |
| 16 | MD-22 (Application for Permission to Conduct Clinical Investigation) | MD-23 (Permission to Conduct Clinical Investigation) | Class A, B, C, D | CDSCO | ₹1,000,000 |
| 17 | MD-24 (Application for Permission to Conduct Clinical Performance Evaluation of New IVD) | MD-25 (Permission to Conduct Clinical Performance Evaluation of New IVD) | Class A, B, C, D | CDSCO | ₹25,000 |
| 18 | MD-26 (Application for Permission to Import/Manufacture Device without Predicate) | MD-27 (Permission to Import/Manufacture Device without Predicate) | Class A, B, C, D | CDSCO | ₹50,000 |
| 19 | MD-28 (Application for Permission to Import/Manufacture New IVD) | MD-29 (Permission to Import/Manufacture New IVD) | Class A, B, C, D | CDSCO | ₹25,000 |
| 20 | MD-39 (Application for Registration of Medical Device Testing Laboratory) | MD-40 (Registration Certificate for Medical Device Testing Laboratory) | N/A | CDSCO | ₹20,000 |
Under the Medical Devices Rules, 2017, regulated by the Central Drugs Standard Control Organization (CDSCO) and State Licensing Authorities (SLA), obtaining market authorization for medical devices and in vitro diagnostics in India requires filing specific application forms based on the device’s risk classification and intended purpose.
At Regallience, we assist manufacturers and importers in navigating these regulatory frameworks for medical devices registration in india. Below is the master matrix detailing application forms, granted certificates, risk categories, authority jurisdictions, and official government statutory fees:
Master Regulatory Fee Structure & License Breakdown
1. Notified Body Registration
Application Form: MD-1 (Registration of Notified Body)
Approval Form: MD-2 (Certificate of Registration)
Risk Class: N/A
Governing Authority: CDSCO
Statutory Fee: ₹25,000
2. Manufacturing License (Class A & B)
Application Form: MD-3 (Grant of License to Manufacture)
Approval Form: MD-5 (License to Manufacture)
Risk Class: Class A & B
Governing Authority: State Licensing Authority (SLA)
Statutory Fee: ₹5,000 (Plant) + ₹500 per product
3. Manufacturing Loan License (Class A & B)
Application Form: MD-4 (Loan License Application)
Approval Form: MD-6 (Loan License Granted)
Risk Class: Class A & B
Governing Authority: State Licensing Authority (SLA)
Statutory Fee: ₹5,000 (Plant) + ₹500 per product
4. Manufacturing License (Class C & D)
Application Form: MD-7 (Grant of License to Manufacture)
Approval Form: MD-9 (License to Manufacture)
Risk Class: Class C & D
Governing Authority: CDSCO
Statutory Fee: ₹50,000 (Plant) + ₹1,000 per product
5. Manufacturing Loan License (Class C & D)
Application Form: MD-8 (Loan License Application)
Approval Form: MD-10 (Loan License Granted)
Risk Class: Class C & D
Governing Authority: CDSCO
Statutory Fee: ₹50,000 (Plant) + ₹1,000 per product
6. Audit & Inspection Maintenance
Application Form: MD-11 (Audit/Inspection Book Maintenance)
Approval Form: N/A
Risk Class: N/A
Governing Authority: CDSCO / SLA
Statutory Fee: $6,000
7. Test License to Manufacture
Application Form: MD-12 (Manufacturing for Clinical/Test Purpose)
Approval Form: MD-13 (Test License Granted)
Risk Class: Class A, B, C, D
Governing Authority: CDSCO
Statutory Fee: ₹500
8. Import License: Non-IVD (Class A)
Application Form: MD-14 (Import License Application)
Approval Form: MD-15 (Import License Granted)
Risk Class: Class A
Governing Authority: CDSCO
Statutory Fee: $1,000 (Plant) + $50 per product
9. Import License: Non-IVD (Class B)
Application Form: MD-14 (Import License Application)
Approval Form: MD-15 (Import License Granted)
Risk Class: Class B
Governing Authority: CDSCO
Statutory Fee: $2,000 (Plant) + $1,000 per product
10. Import License: Non-IVD (Class C & D)
Application Form: MD-14 (Import License Application)
Approval Form: MD-15 (Import License Granted)
Risk Class: Class C & D
Governing Authority: CDSCO
Statutory Fee: $3,000 (Plant) + $1,500 per product
11. Import License: IVD (Class A & B)
Application Form: MD-14 (Import License for In Vitro)
Approval Form: MD-15 (Import License Granted for IVD)
Risk Class: Class A & B (In Vitro)
Governing Authority: CDSCO
Statutory Fee: $1,000 (Plant) + $10 per product
12. Import License: IVD (Class C & D)
Application Form: MD-14 (Import License for In Vitro)
Approval Form: MD-15 (Import License Granted for IVD)
Risk Class: Class C & D (In Vitro)
Governing Authority: CDSCO
Statutory Fee: $3,000 (Plant) + $500 per product
13. Test License to Import
Application Form: MD-16 (Test License for Investigation/Evaluation)
Approval Form: MD-17 (Test License Granted)
Risk Class: Class A, B, C, D
Governing Authority: CDSCO
Statutory Fee: $100
14. Import Investigational Devices (Govt Hospitals)
Application Form: MD-18 (Import for Treatment Purposes)
Approval Form: MD-19 (Permission Granted)
Risk Class: Class A, B, C, D
Governing Authority: CDSCO
Statutory Fee: ₹500
15. Small Quantity Import (Personal Use)
Application Form: MD-20 (Import for Personal Use)
Approval Form: MD-21 (Permission Granted)
Risk Class: Class A, B, C, D
Governing Authority: CDSCO
Statutory Fee: No Fee
16. Clinical Investigation Permission
Application Form: MD-22 (Clinical Investigation Application)
Approval Form: Form 23 (Permission Granted)
Risk Class: Class A, B, C, D
Governing Authority: CDSCO
Statutory Fee: ₹10,000,000 (₹10 Lakhs)
17. Clinical Evaluation for New IVD
Application Form: MD-24 (Performance Evaluation for New IVD)
Approval Form: MD-25 (Permission Granted)
Risk Class: Class A, B, C, D
Governing Authority: CDSCO
Statutory Fee: ₹25,000
18. Device Without Predicate Approval
Application Form: MD-26 (Import/Manufacture Device Without Predicate)
Approval Form: MD-27 (Permission Granted)
Risk Class: Class A, B, C, D
Governing Authority: CDSCO
Statutory Fee: ₹50,000
19. New In Vitro Diagnostic (IVD) Approval
Application Form: MD-28 (Import/Manufacture New IVD)
Approval Form: MD-29 (Permission Granted)
Risk Class: Class A, B, C, D
Governing Authority: CDSCO
Statutory Fee: ₹25,000
20. Medical Device Testing Laboratory Registration
Application Form: MD-39 (Registration of Testing Laboratory)
Approval Form: MD-40 (Certificate of Registration)
Risk Class: N/A
Governing Authority: CDSCO
Statutory Fee: ₹20,000
End-to-End Compliance Execution by Regallience
Whether your company requires an Import License (Form MD-14/15), a Domestic Manufacturing License (Form MD-3/5 or MD-7/9), or a Test License for Clinical Evaluation (Form MD-12/13 or MD-16/17), Regallience manages dossier preparation, portal submissions via CDSCO SUGAM/MD Online, and query responses to ensure smooth medical devices registration in india.
Approved Medical Devices – Devices with Predicate
Import of Approved Medical Devices
Authorized Agent / Registration Holding Services
In India, an overseas manufacturer cannot submit an application for medical devices registration in india directly as an applicant.
Appointing an Indian entity as an Authorized Indian Agent (IAA) or license holder is mandatory in order to submit an application for the registration and import of medical devices under CDSCO regulations.
At Regallience, we hold valid stock and sale licenses (Form 20B and Form 21B) to assist foreign manufacturers in importing their medical devices into India in less time and without administrative hurdles.
We understand the needs of global brand owners and offer tailored compliance services. Regallience can be nominated by overseas companies to act as their official Authorized Agent in India to manage SUGAM portal accounts, filings, and regulatory liaisoning.
Services for Grant of Permission for Import License (Form MD-14, Form MD-15)
Medical devices intended for import into the Indian market must be registered under the Medical Devices Rules, 2017. An application for an Import License in Form MD-14 must be submitted to the Central Drugs Standard Control Organization (CDSCO) by an Authorized Agent appointed via an apostilled or notarized Power of Attorney (POA).
The appointed agent must hold valid wholesale stock and sale licenses (Form 20B and Form 21B / Form MD-42) issued under Indian drug and medical device regulations before filing an import license application on behalf of the overseas manufacturer. Upon successful review and approval, CDSCO issues the official Import License in Form MD-15.
Our regulatory specialists at Regallience help analyze device classifications, risk profiles, and grouping guidelines to establish the exact fee structure and dossier requirements for a seamless grant of approval.
Services for Grant of Permission for Test License to Import Medical Devices (Form MD-16, Form MD-17)
When an importer or manufacturer intends to import small quantities of a medical device for testing, evaluation, demonstration, training, or clinical investigation, an application in Form MD-16 for a Test License to import must be submitted to CDSCO under the Medical Devices Rules, 2017.
Upon evaluation and verification of the technical data, CDSCO grants the official import test license in Form MD-17.
The technical team at Regallience guides applicants through dossier preparation, device quantity justifications, and portal submission to secure the test license efficiently for testing, evaluation, or demonstration purposes.
Manufacturing of Approved Medical Devices
The framework for medical devices registration in india under the Medical Devices Rules, 2017 governs the manufacturing of both medical devices and in vitro diagnostic (IVD) devices.
To enable an efficient digital submission process, the Central Drugs Standard Control Organization (CDSCO) established the SUGAM online portal (and Medical Devices Online Gateway), allowing domestic manufacturers to submit regulatory applications electronically.
Approval pathways on the SUGAM portal are divided based on device risk classification:
End-to-End Filing Support by Regallience
At Regallience, our regulatory specialists assist domestic and global manufacturers in navigating the SUGAM portal workflow, preparing technical dossiers, and ensuring full compliance throughout the process of medical devices registration in india.
Approved Medical Devices – Devices with Predicate
Permission to Manufacture or Permission for Loan License (Class A & Class B Medical Devices)
Medical Device Manufacturing Authorization in India
All medical devices manufactured in India must be registered under the Medical Devices Rules, 2017. Applications seeking manufacturing authorization must be submitted to the designated authority based on the device's risk classification.
Manufacturing License (Form MD-3 / Form MD-5)
For Class A and Class B medical devices, a manufacturer must submit an online application in Form MD-3 to the State Licensing Authority (SLA) of the state where the manufacturing facility is located.
Upon review and approval, the SLA grants the official manufacturing license in Form MD-5.
Loan License (Form MD-4 / Form MD-6)
If a business wishes to manufacture Class A or Class B medical devices using an established, licensed third-party facility, an application for a Loan License must be filed in Form MD-4 with the State Licensing Authority (SLA) of the respective state.
Upon successful evaluation, the Loan License is issued in Form MD-6.
Permission to Manufacture or Permission for Loan License for Sale and Distribution (Class C & Class D Medical Devices)
Manufacturing Authorization for Class C & D Medical Devices
For moderate-high and high-risk medical devices, regulatory oversight for medical device registration in India is managed directly by the Central Licensing Authority.
Manufacturing License (Form MD-7 / Form MD-9)
For Class C and Class D medical devices, manufacturers must submit an online application in Form MD-7 to the Central Licensing Authority, the Central Drugs Standard Control Organization (CDSCO).
Following technical evaluation, site audits, and dossier review, CDSCO issues the manufacturing license in Form MD-9.
Loan License (Form MD-8 / Form MD-10)
When applying for a Loan License to produce Class C or Class D medical devices at an authorized contract manufacturing site, the applicant must file an application in Form MD-8 directly with CDSCO.
Upon approval, permission is granted via Form MD-10.
Permissions for Test License to Manufacture Medical Devices (Form MD-12 & Form MD-13)
Test License for Medical Devices in India
When a manufacturer intends to produce small quantities of a medical device for testing, evaluation, demonstration, clinical investigation, or training, an application for a Test License must be submitted under the Medical Devices Rules, 2017.
Application Form (Form MD-12)
The manufacturer must apply for a Test License through the online portal using Form MD-12.
Granted Permission (Form MD-13)
Upon verification of the technical data and manufacturing facility readiness by the Central Drugs Standard Control Organization (CDSCO), permission to manufacture the medical device for testing, clinical evaluation, demonstration, or training is granted through Form MD-13.
New Medical Devices – Devices Without Predicate
Import and Manufacture of New Medical DevicesUnder the Medical Devices Rules, 2017, a New Medical Device is defined as a device or in vitro diagnostic (IVD) product that does not have an approved predicate or similar product previously cleared by India’s regulatory body, the Central Drugs Standard Control Organization (CDSCO).Because no established domestic baseline exists to verify equivalence, these devices undergo heightened regulatory scrutiny prior to commercial release.
Approved Registration Certificate for Wholesalers, Retailers, or Stockists to Stock, Sell, Exhibit, or Distribute Medical Devices
Under the regulatory framework for medical devices registration in india, the Ministry of Health and Family Welfare, Government of India, issued the 5th Amendment to the Medical Devices Rules, 2017 via Notification G.S.R. 754(E). This amendment established a mandatory Registration Certificate framework for entities engaged in stocking, selling, exhibiting, or distributing medical devices and in vitro diagnostic (IVD) devices across India.
If your business operates as a retailer, wholesaler, distributor, or stockist of medical devices, obtaining an official Registration Certificate from the respective State Licensing Authority (SLA) is mandatory.
Key Legal Framework & Forms: Form MD-41 and Form MD-42
What is Form MD-41? Form MD-41 is the official statutory application submitted online by a retailer, wholesaler, stockist, or distributor to the State Licensing Authority (SLA) to request authorization for selling, stocking, or distributing medical devices and IVDs.
What is Form MD-42? Form MD-42 is the legal Registration Certificate granted by the State Licensing Authority upon successful review of the application. It authorizes the holder to legally stock, sell, exhibit, offer for sale, or distribute medical devices and in vitro diagnostics within India.
Why Choose Regalliance?
At Regallience, we have built a reputation as India’s regulatory firm by delivering compliance structuring and medical devices registration in india at a highly optimized, business-friendly price point. We don’t just fill out forms—we actively manage your regulatory risks.
Our specialized technical support includes complete Device Master File (DMF) and Plant Master File (PMF) auditing to align dossier data and labeling packaging layout with strict Central Drugs Standard Control Organization (CDSCO) and Bureau of Indian Standards (BIS) parameters. Furthermore, we coordinate certified sample testing and clinical evaluation data verification, routing your device documentation through accredited, CDSCO-approved, and NABL-certified testing facilities to smoothly clear statutory safety, performance, and biocompatibility thresholds.
Ready to streamline your Indian market entry? Email us: info@regalliance.in
Frequently Asked Questions (FAQs)
Who regulates medical devices registration in India?
Medical devices are regulated by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare, as per the Medical Devices Rules, 2017
Can foreign manufacturers directly apply for medical devices registration in India?
No, foreign manufacturers cannot apply directly and must appoint an Authorized Indian Agent (IAA) holding valid wholesale licenses (Form 20B/21B).
How are medical devices classified under Indian regulations?
Devices are categorized into four risk-based classes: Class A (Low Risk), Class B (Low-Moderate Risk), Class C (Moderate-High Risk), and Class D (High Risk).
Which authority grants domestic manufacturing licenses in India?
The State Licensing Authority (SLA) issues licenses for Class A and B devices (Form MD-5), while CDSCO grants licenses for Class C and D devices (Form MD-9).
What is the validity period of a CDSCO medical device import or manufacturing license?
Licenses granted under the Medical Devices Rules, 2017 remain valid perpetually, subject to the payment of license retention fees every 5 years.
What is required to import medical devices for testing or clinical trial purposes?
Importers must submit Form MD-16 on the SUGAM portal to obtain a Test License in Form MD-17 from CDSCO.
Are retailers and wholesalers required to register to sell medical devices in India?
Yes, all stockists, wholesalers, and retailers must obtain a Registration Certificate in Form MD-42 by applying via Form MD-41 to their State Licensing Authority.