MEDICAL DEVICES : AN OVERVIEW
What is a medical device?
A medical device includes an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, includes 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 physiological process;
- supporting or sustaining life;
- disinfection of medical devices; and
- control of conception.
The medical devices are regulated by the Central Drugs Standard Control Organisation (“CDSCO”). Within the CDSCO, the Drug Controller General of India (“DCGI”) regulates pharmaceutical and medical devices.
How are medical devices classified/categorized ?
The classification of the devices are based on the intended purpose of the medical device, its operation, the user and the type of technology involved. Basis on this, below is the classification of medical devices:
- Class A (low risk)
- Class B (low moderate risk)
- Class C (moderate high risk)
- Class D (high risk)
Class A and B present the least risk and Class C and D devices present higher risks to patients.
For manufacturing of Class A and Class B medical devices, the license has to be obtained from the State Licensing Authority (“SLA”). Further, for manufacturing of Class C and Class D devices, the license has to be obtained from the Central Licensing Authority (“CLA”).
For import of all classes of medical devices, the license has to be obtained from the CLA.
Where is License Necessary?
A license is required for manufacturing and import of medical devices in India. The term manufacturing means making of goods manually or by machine which upon completion is sold to the customer or in simple words, domestic making of goods. Whereas, import means bringing goods from foreign/external source. For manufacturing medical devices, one requires a license on the basis of the manufacturing site. Manufacturing site is the location where a manufacturing operation is conducted. In case of manufacturing, a license is to be obtained on the basis of whether the manufacturing site is owned by the licensee themselves (simple license) or the manufacturing site is leased by the licensee (loan license).
Depending upon, what form of business (manufacturing or import) one wants to carry in India, they should apply for the license along with other documents as may be required. Thereafter, CDSCO, on being satisfied of the application and other documents, grants the license to the applicant.
What is the timeline and validity of the license ?
For manufacturing of medical device in India, the license shall be issued or rejected within 45 days, from the date of issuance of the inspection report by the authority. An inspection report is a report prepared by the inspection team which contains the findings on each aspect of manufacturing site along with the recommendations to the CLA. The inspection report is submitted within 60 days from the date of application.
The license remains valid in perpetuity, however, it is subject to payment of license retention (continue with the possession of the license) fee every five years.
For import of medical devices in India, license is granted or rejected within a period of 9 months from the date of application. The license remains valid in perpetuity, provided it is not cancelled or surrendered.
How are medical devices recognized by CDSCO ?
CDSCO has regulated 37 categories of medical devices under the Medical Devices Rules, 2017 and Drugs and Cosmetics Act, 1940 (“Notified Devices”). The devices which are currently not recognized by the CDSCO are the Non-Notified devices (“Non-Notified devices”). You may click here to see the list of Notified Devices
The CDSCO is in phases regulating the Non-Notified Devices from time to time, the Non-Notified Devices brought under the purview of the regulated devices are termed as the newly notified devices (“Newly Notified Devices”).
What is the process of Registration and obtaining License ?
As indicated above, for the business of medical devices one needs to either obtain a licence or registration for both manufacturing and import. The registration requirement is however, only is for the transitional period to facilitate the process of manufacturing and/or import, until all the medical devices are regulated by the CDSCO.
The applicant manufacturing or importing Notified Devices in India are not required to go through the registration process and instead is required only to obtain a simple license, loan license or import license from the CDSCO to start its business.
The Non-Notified Devices and Newly-Notified Devices require registration and licensing depending upon the time period within which one wants to do business in India. The process followed would be :
- October 1, 2021 to September 30, 2022 – Registration will be required to import or manufacture Non-Notified Devices and Newly-Notified Devices, but no licence will be required;
- October 1, 2022 to September 30, 2023 – Licence will be required to manufacture, import, distribute or sell only Class A or Class B and not for Class C or Class D Non-Notified Devices and Newly-Notified Devices, Class C or Class D will require only registration;
- After October 1, 2023 – Licence will be required to manufacture, import, distribute or sell Class C and Class D medical devices as well.
Therefore, October 1, 2023, onwards, a license will be mandatory and required to manufacture and import all categories of medical devices.
What are the consequences of not registering or obtaining a licence or registration ?
A medical device to which registration requirement applies cannot be legally manufactured or imported into India without registration after October 1, 2021. The manufacturers and importers of such medical devices would have to obtain a registration for such devices in India before they can market these devices. If a device is manufactured or imported after October 1, 2021 into India for marketing purposes without a registration, then it would result in criminal prosecution.
Further, in case the license for Notified Devices is not obtained prior to manufacturing or importing, the licensing authority would halt the operations unless it is secured. Moreover, it would result in criminal prosecution including imprisonment upto 5 years and fine which shall not be less than INR 100,000 or three times the value of medical devices confiscated.
CHAPTER III :
What are the issues faced by manufactures and importers doing business of medical devices in India ?
- Whether to obtain a registration certificate or license – Based on the category of the medical devices, it will be decided whether the device would be subject to registration or license.
- The category under which the medical device falls – This is decided based on the intended use of the medical device.
- The requirement of agent while obtaining import licence – It is to be determine whether the importer requires an agent while obtaining a licence or not.
- The obligation of labelling requirement- Every producer and importer who receives a registration number for their medical equipment must show the number on the label.
- The entire process of registration and timelines thereto – The nitigrities of the license and registration required to be adhered to while making an application.
What BLC can do for you?
Broadly the legal and regulatory service and assistance provided by the firm in the area of medical devices and equipment are as under:
- Assistance in all of the above discussed issues faced by a manufacturer or importer;
- Assistance in procuring other licences and certificates that may be required for carrying out business in India by the manufactuere or importer (please click here to refer to our article on other registrations and certificates that are required for manufacturing and importing medical devices in India);
- Regulatory & technical services, consultation and assistance throughout the registration/license process;
- Custom clearance support to the importers;
- Drafting of all legal and technical documents under one umbrella for medical device manufacturer and importer;
- Assistance in preparing and reviewing the labels and artwork of the medical devices;
- Liaison with different Government authorities of India on behalf of the medical device manufacturers/importers;
- Providing assistance in appointment of authorised agent services to the foreign exporters/manufacturers of medical devices;
- Preparation and submission of response to the clarification letter (query letter), if any, issued by the CDSCO or other licensing authority;
- Key point of reference for all correspondence with regulatory/competent authority for all kinds of approval and registration.