A. Background:
Apply for MD- 15 License on SUGAM
India Medical Device Regulations
The recent political changes resulting in a pro-business environment has made manufacturers from the Healthcare industry stand up and take notice of India. In 2023, the Indian healthcare industry reached a value of US$ 372 billion reflecting its expansive growth and the strategic pricing models employed by healthcare providers and distributors. This growth rate is expected to place the Healthcare sector at the top of the revenue generating sectors in the country. The key players of the wide and diverse spectrum of Indian healthcare are Medical devices, pharmaceuticals, biotechnology, and more recently the medical tourism sector. The rapidly growing economy of India makes it one of the strong partners in the BRICS. Promising economic growth, rising disposable incomes, large pool of English speaking and talented human resources, shift from communicable diseases to lifestyle related diseases has made the Healthcare industry in India an attractive investment option. Growth is seen across all sectors of healthcare: medical devices, pharmaceuticals, labs, hospitals, IT services and other providers.
B. Regulation:
Earlier, manufacturers could sell medical devices in India without any jurisdictions. Since 2006, medical devices entering India must be in compliance with the Indian Medical Device Regulations set forth by the Central Drug Standards Control Organisation (CDSCO). The CDSCO is responsible for approval and regulation of New Drugs and Clinical Trials in the country, laying down the standards for Drugs, control over the quality of imported Drugs, coordination of the activities of State Drug Control Organizations and providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act, 1940 and Rules 1945. Further to this, Medical Device Rules, 2017 (MDR 2017) and Cosmetics Rules 2020 were introduced to give a structure and further streamline the regulatory compliances in India. These Regulations ensure that all medical device manufacturers adhere to stringent safety standards, requiring comprehensive registration processes and compliance checks before entering the Indian market.
C. What are Notified Medical Devices in India?
Previously medical devices which required registration in India included spinal needles, cochlear implants, annuloplasty rings, tracheostomy tubes, syringes and needle, dental implants, surgical sealants, heart valves, cardiac stents, orthopedic implants, endotracheal tubes, and catheters, among others. Now as per the 11th February 2020 notification S.O.648(E) set by the CDSCO, ALL medical and IVDs require registration and are added in the notified medical device and IVD category. These notified medical device include an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or 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 or modification or support of the anatomy or of a physiological process;
- supporting or sustaining life;
- disinfection of medical devices; and
- control of conception
D. Navigating the Regulatory Pathway for Notified Medical Devices in India under the Medical Devices Rules, 2017:
The Indian medical device industry is governed by a comprehensive set of regulations and guidelines outlined in the Medical Devices Rules, 2017 set by the CDSCO. This framework is designed to ensure the safety, efficacy, and quality of medical devices, from their development phase to commercialization. Understanding the regulatory pathway for the registration process is crucial for manufacturers and importers aiming to enter the Indian market. Adherence to these regulations and guidelines set by the CDSCO ensures that medical devices meet the necessary standards for safe and effective use.
Manufacturing Licensing for Commercialization
For domestic manufacturing, the licensing requirements differ based on the device class:
- Class A & B Devices: Applications are submitted in Form MD-3 and MD-4. Upon approval, the State Licensing Authority (SLA) issues licenses in Forms MD-5 and MD-6, respectively as per the relugations set by the CDSCO under the Medical Device Rules (MDR 2017).
- Class C & D Devices: For these higher-risk devices, applications are submitted in Form MD-7 and MD-8, with licenses issued in Forms MD-9 and MD-10 by the Central Licensing Authority (CLA) as per the guidelines of CDSCO.
Import Licensing for Notified Medical Devices / IVDs
To import notified medical devices into India, companies must apply for an import license or Form MD-15. The application or registration process involves submitting Form MD-14 to the CDSCO. Upon approval, CDSCO issues a Import license in Form MD-15, applicable to medical devices across all risk classes — Class A, B, C, and D in India. In case no substantial equivalent data / predicate device is available in the Indian market, the manufacturer has to make an application in Form MD-26 and submit the data related to Clinical evidence, safety and efficacy, validation, technical file, etc. as per the Part IV of Fourth Schedule of Medical Device Rules (MDR 2017). Permission for this is granted in Form MD-27 by the CDSCO following which the importer has to apply for the Import license in Form MD-15 to sell in the Indian market.
Clinical Investigation (CI) and Compliance
If a medical device is to be used for clinical investigations, specific permissions are required:
- Test License: Manufacturers need to apply and registrer using Form MD-12 for a test license (issued in Form MD-13). For imported devices, the application is made via Form MD-16, with the license issued in Form MD-17.
- Investigational Medical Devices: Additional permissions are necessary for investigational devices, including the submission of a clinical investigation plan per the Seventh Schedule of Medical Device Rules MDR-2017. This involves generating clinical data by conducting pilot/pivotal study on the Indian population, with application made in Form MD-22 and permission to perform clinical trials granted in Form MD-23.
Quality and Compliance Requirements
Before a device can be marketed, manufacturers must demonstrate compliance with the Essential Principles of Safety and Performance (EPSP). This includes producing at least three batches to generate Quality Control (QC) data, stability and validation data, and submitting preclinical studies (wherever applicable).
Regulatory Documentation
Manufacturers must submit various documents, including:
- Regulatory Documents: Compliance with the Fourth Schedule of Medical Device Rules MDR-2017.
- Legal Documents: Required for validation and adherence to regulations.
- Technical Documents: Including the Plant/Site Master File and Device Master File.
E. Conclusion:
The Medical Devices Rules, MDR 2017, provide a structured pathway for the development, import, and commercialization of medical devices in India. By adhering to these guidelines, manufacturers and importers can ensure that their products meet the stringent standards required for market entry. The centralized system, facilitated through online portals like SUGAM and NSWS, streamlines the application and registration process, making it more accessible for stakeholders. For those navigating this complex landscape, understanding these regulations is essential for successful market entry and compliance. With a robust regulatory framework, India continues to be an attractive destination for medical device innovation and commercialization.
Morulaa HealthTech specializes in registering medical devices with the CDSCO in India. Our team of experts specialize in the notified medical device India registration process and can assist in grouping your products, determining feasibility, labeling requirements and timeframe to market. Please contact us to register your medical device
F. Appendix:
Below is a sample list of notified medical devices regulated in India as per Medical Device Rules MDR 2017. For an exhaustive list with risk classification, you can refer to our medical device classification blog.
| Industry | Medical Devices |
| Aesthetics | Breast Implants |
| Tissue grafts | |
| Dermal Filler | |
| Implants | |
| Injections | |
| BloodStorage | Blood Bag System |
| Bloodlines | |
| Filters | |
| Platelet Storage | |
| Cardiology | Annuloplasty System |
| Heart Valves | |
| Balloon Catheters | |
| Bioprosthetics | |
| Cannula | |
| Cardioverter Defibrillator | |
| Catheters | |
| Access Port System | |
| Cannula | |
| Guide wires | |
| Sheaths | |
| Shunt | |
| Occlusion and Aspiration System | |
| Plaque Excision System | |
| Stents | |
| Filter System | |
| Pacemaker | |
| Contraceptive | Condoms |
| Copper T | |
| Dental | Denture cream |
| Implants | |
| Abutments | |
| Needle | |
| Scaffolds | |
| ENT | Hearing Prosthesis |
| Implants | |
| Ossicular Prosthesis | |
| Gastroenterology | Catheters |
| Feeding Tube Kit | |
| Hernia System | |
| Ligation Device | |
| Stents | |
| Gynaecology | Catheters |
| Grafting System | |
| Needles | |
| Tampons | |
| Pelvic Floor Repair System | |
| Stents | |
| IVD | Blood Testing |
| Cell Processing | |
| Filter Sets | |
| Lab Kit | |
| Prep Pads | |
| Stem Cells | |
| Neurology | Catheters |
| Distraction System | |
| Fixation System | |
| Grafting System | |
| Implants | |
| Reconstruction Device | |
| Stents | |
| Guide wires, Catheters | |
| Oncology | SIR Spheres |
| Ophthalmology | Bandages |
| Catheters | |
| Eye Drops | |
| Implants | |
| Intraocular Gases | |
| Lens | |
| Occluder | |
| Orthopedic | Bone Cements |
| Bone Substitutes | |
| Cervical Plates | |
| Bone Void Filler | |
| Plates | |
| Screws | |
| Cables | |
| Casting Tapes | |
| Coils | |
| Discs | |
| Metal Acetabular Augments | |
| Metal Revision Shells | |
| Femoral Cone | |
| Mesh | |
| Metal Tibial Cone | |
| Fixation System | |
| Grafting System | |
| Haemostatic Powder | |
| Hip implants | |
| Knee implants | |
| Elbow implants | |
| Joint implants | |
| shoulder | |
| Nail system | |
| Tibial Augments | |
| Metallic Anchors | |
| Pulmonary | Catheters |
| Suction System | |
| Tubes | |
| Valve system | |
| Spine | Bone Cements |
| Bone Void Filler | |
| Cages | |
| Cervical Plates | |
| Discs | |
| Fusion Device | |
| Spacer | |
| Fixation System | |
| Implants | |
| Screws | |
| Surgery | Catheters |
| Disposables | |
| Endoscopic Applicator | |
| Tips | |
| Syringes and Needles | Blood Transfusion Set |
| Cannula | |
| Catheters | |
| Infusion Wires | |
| IV Flow Regulators | |
| IV Sets | |
| Needles | |
| Stopcocks | |
| Syringes | |
| Urology | Catheters |
| Stents | |
| Dialysis | |
| Filters | |
| Guide Wires | |
| Stents | |
| Tapes | |
| Tubes | |
| Vascular | Cannula |
| Catheters | |
| closure Device | |
| Elite snare | |
| Embolization Device | |
| Filters | |
| Grafting System | |
| Guide Wires | |
| Occluder | |
| Prosthesis | |
| Reconstruction Device | |
| Sheaths | |
| Wound Care and Surgical Dressings | Bandages |
| Casting Tapes | |
| Catheters | |
| closure Device | |
| Collagen Membrane | |
| Dressings | |
| Closure Device | |
| Fasteners | |
| Hemostatic Foam | |
| Hemostatic Pads | |
| Mesh | |
| Splint Rolls | |
| Staplers | |
| Surgical Drapes | |
| Surgical Sealant | |
| Sutures |