Software as Medical Device is a very fresh topic in the medical industry in India. This outcome is triggered by the adoption of the internet, digital healthcare platforms, increased number of chronic diseases and adoption of software for monitoring physiological parameters by doctors or other healthcare providers.
Software as Medical Device in India
In recent years software technologies have brought innovative changes to the healthcare sector. Monitoring, diagnosis, prevention and treatment of diseases or drug manufacturing are dependent on software technologies. On 11th February 2020, the Ministry of Health and Family Welfare, Government of India, widened the scope of medical devices that are regulated under the Drugs and Cosmetics Act, 1940 and Medical Devices Rules, 2017 by issuing a notification. Any software or app used for diagnosis, prevention or monitoring of any disorder or disease, is part of or used in conjunction with a device or that is capable of or assists in the investigation of any physiological process are included in the meaning of a medical device and thus regulated as Drug under the 1940 Act effectively from 1st April 2020. For included in the meaning of drugs, this software as a medical device must be used for any of the following:
- Diagnosis, monitoring, prevention, treatment or alleviation of any disease or disorder diagnosis, monitoring, treatment, alleviation or assistance for any injury or disability
- The investigation, replacement or modification or support of the anatomy or of a physiological process
- Supporting or sustaining life
- Disinfection of medical devices
- Control of conception.
Earlier software as a medical device was limited to the context of clinical investigation and in relation to in-vitro devices. With this inclusion, any software falling under the meaning of Drugs as a medical device needs to be registered as per the Drugs and Cosmetics Act 1940 for its importation, manufacturing, sale or distribution in India. Such registrations are done by a drug regulatory authority or agency, i.e., Central Drug Standards Control Organisation.
Software as Medical Device must fulfil the following criteria:
- The intention of the manufacturer is to be used for a medical purpose
- Meets the definition of Medical Device as provided under Medical Device Rules
Software as Medical Device at the Global level
Software technologies in the medical field are accelerated worldwide due to the Covid-19 pandemic. In the whole world, there are three types of software related to a medical device such as:
- Software in Medical Devices, SiMD;
- Software as Medical Devices, SaMD and
- Software used in manufacturing or maintenance of a medical device
There are various uses of software in the medical field as a medical device, such as screening, diagnosis, monitoring and alerting, etc. Healthcare agencies of developed countries like the European Union, the United States, Canada and Australia have given defined regulations for such software uses as a medical device. Some of such countries have already developed guidelines, and others are in process. Worldwide, countries have accepted the harmonised international guidelines for evaluating and approving software. Some of the important guidelines available for this software related to a medical device are listed below:
- International Medical Device Regulators Forum, IMDRF guidance for classification, Quantity Management System, cybersecurity assessment, clinical evaluation
- European Union Medical Device Regulations have detailed information on this device.
- MDCG guidance on qualification and classification of it, CER/PER requirements
- US FDA guidance on cybersecurity, clinical evaluation and registration requirements for different types of software, for example, decision systems, PACS, mobile applications, etc.
- Health Canada guidance document on definition and classification
- TGA’s new regulations for a software-based medical device became effective from August 2020.
The registration of this software as medical devices in global markets are handled by a case approach and requires close interaction with respective health agency for approval and licensing. The basic steps that are followed for registration of these devices include:
- Determining whether the given software qualifies for software as a medical device or not
- Classification of these devices based on the involvement of risk
- Identification of applicable standards and data requirements by the respective health authority or agency
- Generate the data as required by the concerned health agency or authority
- Compilation of technical files as per the country’s requirements
- Submission and query resolution till approval
- Post-approval life cycle management
The term software as medical device is first time defined by the International Medical Device Regulators Forum (IMDRF) as software that intends to be used for one or more medical purposes and perform these purposes without being part of any hardware medical device. This is a far more purposive definition due to using words for medical purposes.
The European Commission’s Medical Device Coordination Group releases guidance on criteria for software qualifications under relevant European Union regulations. The guidance is illustrative and includes examples. It is instrumental in the Indian context to the extent the Central Government of India considers subscribing and implementing such guidance from another country.
Therefore, an absence of a specific regulatory framework needed clinically evaluate software as a medical device restricts the ability of the Central Drugs Standard Control Organisation to assure the safety or effectiveness of any software that is essential in light of the result or impact of software in decision making that impacts the clinical outcomes and patient care.
In the long run, this Central Drugs Standard Control Organisation, CDSCO adopts international standards and classification schemes where this software is categorised based on the level of impact on the patient or public health and provides explicit exemptions (as adopted by the European Commission/ International Medical Device Regulators Forum (IMDRF) for instance).
Registration of Software as Medical Device
According to Medical Device (Amendment) Rules, 2020, manufacturers and importers of all medical devices in India must register their medical devices from 1st October 2021 to 1st October 2022.
In order to obtain such registration, the manufacturers and importers of software relating to a medical device with the Central Standards Control Organisation (CDSCO).
A manufacturer or importer of medical devices is the one who can apply for the registration of such devices. For an importer to get registration, it is a pre-requisite to have a wholesale drug license; however, CDSCO is currently permitting registration without such a license.
After submission of the application for registration, a file number is generated, which concludes that the registration process is completed. This file number is the registration number. This registration is dependent on the manufacturing site, meaning different registration numbers are granted for different manufacturing sites.
Specific regulatory processes that are required to be there for considering software as medical device are as follows:
- Risk Management System
- Quality Management System
- Post Market Surveillance System with PMCF
- Clinical Evaluation and Clinical Evaluation Report
- All required technical documents
Objective of registration
The objective of the Indian Government behind imposing registration appears to be phase-wise regulation of medical devices. The pre-requisite for getting registration is the existence of an ISO 13485 certificate (Quality Management System, QMS for medical devices) obtained from a certification body accredited with the International Accreditation Forum (IAF) or National Accreditation Board for Certification Bodies (NABCB) to the manufacturer of software as medical devices. No safety or effectiveness data are required to be presented for obtaining registration.
The Government of India intends to ensure that by 1st October 2021, all medical devices sold in India must be manufactured where the Quality Management Systems (QMS) meet the standards specified in ISO 13485 as certified by any Accredited Certifying Body.
Information required for registration
Following information is required to be provided for obtaining registration:
- Details of the manufacturer including name, address, phone no., fax and email id.
- Details of the site, including name, address, email id, fax, and contact number
- Nature of activity
- Category of device
- Product Description
- Generic name and model number
- Intended use
- Source/ material used for manufacturing
- Shelf life
- Storage condition
- Brand name (If the applicant has trademark registration)
Documents required for registration
Following are the documents that are required for obtaining registration:
- ISO 13485 Certificate
- Certificate of Foreign Government (for imported devices)
- Free Sale Certificate (for imported devices)
- Undertaking from the applicant, stating that all information and documents provided are genuine and authentic.
Consequences of not registering
A medical device cannot be legally manufactured without registration if there is a requirement for its registration. Before marketing this software as medical device, its manufacturers and importers must obtain a registration. If a device is manufactured or imported into India for marketing purposes without valid registration, then it attracts penal action under the Drugs and Cosmetics Act 1940.
In case the applicant submits false information or documents, then CDSCO may cancel the whole or a part of the registration by making it impossible to sell such software as medical devices in question in India.
Software as medical device is a newly added device under the Drugs and Cosmetics Act 1940 and Medical Device Rules made thereunder due to the growth of technologies in the health care field. It is something which adds value to the medical field, and it has its own medical purposes. It was added by the Ministry of Health and Family Welfare in February 2020. It is registered the same as other medical devices, so it is also included in the meaning of drugs in our country.