The Indian medical device regulatory system has become more complicated in recent years. With advancing medical technology and the exponentially rising need of medical devices in the country, new reforms and rules have come into effect.
The Indian law that regulates quality and safety of medical devices has been amended and it will now apply to all medical devices, effective April 1, 2020.
Regulatory bodies responsible for medical device registration in India?
- The Central Drug Standards Control Organization (CDSCO), which is part of the Ministry of Health and Family Welfare is India’s main regulatory body for pharmaceuticals and medical devices
- The Drug Controller General of India (DCGI) is the key official within the CDSCO. The DCGI is responsible for the approval of the manufacturing of certain drugs (vaccines, large volume parenterals, blood products, r-DNA derived), specific medical devices, and new drugs.
Medical device:
- The standards of quality and safety of medical devices are regulated in India by a law called The Drugs and Cosmetics Act, 1940 (“DCA”). The scope of DCA is restricted to only those medical devices which are notified by the Government from time to time as “drugs” (commonly referred to as “notified medical devices”).
- The Medical Devices Rules, 2017 (“MDR”) have been framed under DCA. These rules lay down comprehensive quality requirements to be followed by marketers / importers / manufacturers / sellers of notified medical devices.
- The way DCA and MDR ensure quality and safety of notified medical devices at all levels of the supply chain is by enforcing a mandatory license requirement. All importers / manufacturers / sellers of notified medical devices must obtain a license from the appropriate licensing authority before undertaking any commerce in notified medical devices. A license is issued only after quality checks. The license holder’s business premise is subject to periodic inspection. A license holder is also required to maintain detailed records of the sale-purchase undertaken in relation to notified medical devices and ensure traceability in the event of a quality or safety-related failure or complaint.
Classification of medical devices and regulatory pathway
- Medical devices have been categorized into A, B, C and D classes and are governed by respective central and state regulatory authorities
- Regulatory bodies classify medical devices based upon the associated risk (the risk factor involved increases from A to D) and have defined relatively easy procedures for license applications. Low-risk devices include equipment like thermometers whereas high-risk devices include pacemakers, heart valves and others. The devices are further classified as surgical or non-surgical devices based upon their invasiveness. License for class “A” devices is easy to obtain as compared to class “D” devices.
- Authorities responsible for issuing certifications:
- The State Licensing Authority (Class A and B devices) and
- The Central Licensing Authority (Class C and D devices)
- Similarly, rules and guidelines have been promulgated by the government for the import of medical devices. Whereby, all one needs is to have an authorized Indian agent to apply for the license.
Until February 11, 2020, the Government had regulated or notified following 37 categories of medical devices as drugs.
| S.No | Devices |
| 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 | 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 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) |
On February 11, 2020, the government exercised its powers to notify one or more categories of medical devices as “drug” to actually notify a new definition of medical devices. As per the notification, effective April 1, 2020, the medical devices that fall under the following definition will be regulated as “drug” under the DCA and MDR:
All devices including 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
The above new definition is intended to cover all medical devices, as per technical discussions that preceded the notification of the above definition. Thus, by virtue of this definition, all medical devices sold in India will come to be regulated by DCA and MDR from April 1, 2020, when the definition takes effect.
What’s the impact on Industry with the amendment in law?
- Before October 1, 2021, all presently unregulated medical devices will have to be registered by respective importers or manufacturers with the Drugs Controller General of India. However, those medical devices which are already regulated or have been notified to be regulated are exempted from the requirement of registration (list of 37 categories of medical devices which are exempt from registration are listed above).
- Before August 11, 2022, importers, manufacturers, distributors, whole sellers and retailers of presently unregulated Class A (low-risk) and Class B (low-medium risk) medical devices sold in India will have to compulsorily obtain a license.
- Before August 11, 2023, importers and manufacturers, distributors, whole sellers and retailers of presently unregulated Class C (medium-high risk) and Class D (high risk) medical devices sold in India will have to compulsorily obtain a license.
In order to obtain registration for medical devices, the importers and manufacturers of the medical devices have to be certified as compliant with ISO-13485 (Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes).
For the purpose of this article, all medical devices which were not notified until February 11, 2020 (i.e. other than the list of 37 categories of medical devices listed above), and will now be covered by the new definition of medical devices will be referred to as “Newly Notified Medical Devices”.
The Medical Device (Amendment) Rules, 2020
- On February 11, 2020, the government also notified The Medical Device (Amendment) Rules, 2020 (“MDR Amendment”). The MDR Amendment introduces two changes to MDR.
- The first is introduction of a new chapter for registration of Newly Notified Medical Devices by their respective manufacturers and importers.
- The second is an exemption for the 37 categories of already regulated or notified medical devices from the requirement of registration introduced by the new chapter.
Requirement of registration
- The manufacturers or importers of Newly Notified Medical Devices will be required to compulsorily register their medical devices with the Drugs Controller General of India (“DCGI”) before October 1, 2021.
- The DCGI will start accepting applications for registration through a dedicated online portal called “Online System for Medical Devices” from April 1, 2020 (or from such later date by when the online portal to ready to accept applications).
- There is no time-frame prescribed as of now for processing of the application for registration by DCGI.
- It appears that the registration will be done instantly after submission of all information and documents on the online portal i.e. without any examination of the information and documents submitted by the applicant at the hands of DCGI.
- The registration process is relatively simpler and should not be equated to a full-fledged marketing registration or authorization. Any importer or manufacturer of Newly Notified Medical Device will be able to obtain registration on the submission of the following information:
- Name of the company or firm or any other entity
- Name and address of manufacturing site (for devices manufactured in India only)
- Specification and standards of medical device (for imported devices only)
- Details of medical devices (Generic Name, Model No., Intended Use, Class of Medical Device, Material of Construction, Dimensions (if applicable), Shelf Life, Sterile or Non-sterile status, Brand name only if registered under India’s trade mark law)
- Certificate of compliance with respect to ISO 13485 standard accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum in respect of such medical device
- Free sale certificate from country of origin (for imported devices only)
- A duly signed undertaking stating that the information furnished by the applicant is true and authentic
- The registration will be complete only upon generation of a registration number.
If an importer or manufacturer is unable to obtain registration for its Newly Notified Medical Device before October 1, 2021, then it will not be able to market and sell its medical device in India until a registration is obtained.
The importer or manufacturer of a medical device which belongs to one of the 37 categories of medical device regulated or notified prior to February 11, 2020 (listed above) are exempt from the requirement to obtain registration for its medical device and therefore can continue to carry on their business on the strength of the license issued by appropriate licensing authority.
Regulatory noncompliance consequence:
- A certificate of compliance with ISO-13485 (Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes) is mandatory for registration of Newly Notified Medical Device. Therefore, an importer or manufacturer of a registered medical device will have to ensure that the requirements of ISO 13485 are met at all times. Broadly speaking, ISO 13485 requires creation, documentation and implementation of a quality management system which is to be supplemented by an independent audit from time to time.
- Once an importer or manufacturer registers its medical devices, it will have to strictly conform to its documented quality management system.
- If any gap is found in the implementation of quality management system by DCGI, it will have the right to suspend or cancel the registration of the medical device. An order of suspension or cancellation of registration for medical device will prevent the importer or manufacturer of said medical device to further import or manufacture said medical device.
Requirement to obtain a license
In addition to registration, importers and manufacturers of Newly Notified Medical Devices will have to obtain a license under MDR before the prescribed deadline (see table for deadlines).
In the table below, we have listed the name of the authority who will issue the license to importers and manufacturers along with prescribed deadlines.
| Class of medical device | Licensing Authority | Stipulated timeline for processing application | Deadline for obtaining license |
| Class A and B (import) | DCGI | Up to 9 months from the date of application | August 11, 2022 |
| Class C and D (import) | DCGI | Up to 9 months from the date of application | August 11, 2023 |
| Class A (manufacture) | State-level Licensing Authority | Up to 45 days from the date of application | August 11, 2022 |
| Class B (manufacture) | State-level Licensing Authority | Up to 140 days from the date of application | August 11, 2022 |
| Class C and D (manufacture) | DCGI | 120 – 180 days (estimated) | August 11, 2023 |