INTRODUCTION

The company has developed software medical devices that are supported by AI, with their flagship products being SYmpi and CIE, which cater to the needs of both patients and doctors. They have already received the testing licensing from CDSCO, and are now looking to acquire further clinical trials and other licenses. In order to ensure that their products meet the necessary standards, the company needs to adhere to various laws, regulations, and compliances related to software as a medical device.

MEDICAL DEVICES

The Indian Ministry of Health and Family Welfare has implemented the Medical Device Rules (MDR) under the Drugs and Cosmetics Act to regulate all medical devices in India. The MDR covers devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in humans or animals, as well as substances affecting the structure or function of the human body. The MDR also includes software and accessories. The Health Ministry released draft notifications in October 2019 to further streamline the regulatory framework, including the registration of all medical devices on a portal developed by the Central Drugs Standard Control Authority. The new definition of medical devices under Section 3(zb) of MDR, issued on February 11, 2020, broadens the scope of regulated devices to include those intended for diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder, investigation, replacement or modification or support of the anatomy or physiological process, supporting or sustaining life, disinfection of medical devices, and control of conception.

CLASSIFICATION OF MEDICAL DEVICES

Medical devices in India are classified into five segments, including Consumables & Disposables, Diagnostic Imaging, Dental Products, Orthopaedics & Prosthetics, and Patient Aids. The MDR categorizes medical devices into four classes based on risk, with Class A being the lowest and Class D being the highest. The CDSCO regulates the import and manufacturing of Class C and D devices, while the concerned State Licensing Authorities regulate the manufacturing of Class A and B devices and the sale and distribution of all devices. Specific regulations and standards, including S.O. 648(E) dated February 11, 2020, Medical Device Definition Medical Device Rules, 2017, and ISO 13485:2016 and ISO 14971:2019, must be adhered to for marketing Software as a Medical Device (SaMD) in India.

REGISTRATION V. LICENSING CHANGE

The MDR Amendment (April 2020) mandates the online registration of non-regulated medical devices with the drug regulator in India through a dedicated portal. This registration is voluntary for the first 18 months and mandatory thereafter, and upon successful registration, the medical device is exempt from regulatory compliance for 30-42 months depending on the device classification. The registration process has been simplified and the deadline was October 1, 2021. Importers or manufacturers need to provide various information such as medical equipment specifications and standards, device information, and certificates of compliance. A registration number is issued upon successful completion of the process. However, any newly notified medical devices that are not registered will be subject to immediate regulatory compliance.

LEGAL AND REGULATORY FRAMEWORK

DRUGS AND COSMETIC ACT & RULES

The Central Drugs Standard Control Organization (CDSCO) in India regulates the manufacture, sale, import, and distribution of medical devices and in-vitro diagnostics (IVD) through a set of guidelines called Schedule M III. The guidelines are aimed at ensuring that medical devices and IVDs are safe, effective, and meet the necessary quality standards. The guidelines outline the requirements for the quality control of medical devices and IVDs, including their design, development, manufacturing, and packaging. Medical devices are subject to Good Manufacturing Practices (GMP) requirements as specified under Schedule M III and must comply with labeling requirements outlined in Rule 109-A. The schedule requires that all medical devices and IVDs sold in India must be registered with the CDSCO, and manufacturers must comply with the relevant quality standards for these products. The guidelines also specify the requirements for clinical trials and post-marketing surveillance of medical devices and IVDs.

Section 109-A provides for the Labelling of Medical Devices, which includes various details necessary for the user to identify the device and its use. Section 109B provides for certain labeling requirements for medical devices for export are exempt, while Section 109C talks about the shelf life of medical devices which must not exceed 60 months from the date of manufacture. Additionally, Rule 125-A specifies standards for medical devices to ensure their safety and effectiveness.

MEDICAL DEVICES RULES

The Medical Device Rules, 2017 (MDR-2017) is the main legislation in India that regulates the manufacturing, authorization, import, export, and sale of medical devices. The Central Drugs Standard Control Organization (CDSCO) at the central level and State Licensing Authorities (SLAs) at the state level enforce the MDR and the Drugs and Cosmetics Act, 1940 (D&C Act). The MDR requires licenses for importing, selling, manufacturing, and loaning medical devices – Attached as Annexure 1.

NOTIFICATIONS

The Ministry of Health and Family Welfare in India has introduced the Medical Devices (Fifth Amendment) Rules, 2022, which include a new rule, 87A, that requires a registration certificate for selling, exhibiting, or distributing medical devices, including in vitro diagnostic medical devices. Applicants must apply for the registration certificate in Form MD-41 to the State Licensing Authority and must purchase devices only from licensed manufacturers, importers, or registered entities. The certificate holder must maintain proper storage conditions and separate records for purchases and sales for at least two years. The registration certificate, issued in Form MD-42, remains valid perpetually, subject to payment of the retention fee as specified in the Second Schedule. Failure to pay the fee within the specified time will result in the cancellation of the registration certificate.

QUALITY REQUIREMENT

In India, the registration of Newly Notified Medical Devices requires compliance with ISO-13485 standards for quality management systems. Registered importers or makers of medical devices must adhere to these standards at all times. Medical devices must meet certain standards set by the central government, BIS, the Health Ministry, ISO, or other pharmacopoeial standards. The Medical Devices Rules (MDR) mandate the use of a Quality Management System (QMS) during the manufacture of medical devices and in-vitro diagnostics. ISO 13485:2016 is applied by regulators, the medical device industry, and certification bodies in India to ensure quality systems in the medical device sector. Recently, the Ministry of Commerce and Industry introduced the voluntary certification scheme “Indian Certification of Medical Devices (ICMED-13485) Plus,” which integrates quality management and product certification standards with regulatory requirements.

ADDITIONAL LAWS WHICH MAY APPLY

The labeling and pricing requirements for medical devices in India are regulated by different acts and rules. The MDR, 2017 requires Notified Medical Devices to be labeled with specific details, including name, manufacturer’s details, net contents, date of manufacture, batch number, and license number. The Legal Metrology (Packaged Commodity) Rules, 2011 mandates additional details like the maximum retail price, the common name of the commodity, contact information for consumer complaints, etc. The Drug (Prices Control) Order, 2013 mandates that all Notified Medical Devices display the maximum retail price on the label. Pricing is also regulated under DPCO 2013, which classifies medical devices as Scheduled or Non-Scheduled Formulations.

The advertising and sales promotion of Notified Medical Devices and in vitro diagnostic devices in India are subject to the provisions of the DCR regulations, as long as they are not in conflict with the MDR. The labeling of Notified Medical Devices is prohibited from suggesting that they can prevent or cure certain ailments and diseases listed in Schedule J of the DCR. Indian law also restricts the advertising of medical devices under the Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954. The act prohibits advertisements that suggest or encourage the use of drugs or medical devices for certain conditions listed in its schedule. The Uniform Code of Pharmaceutical Marketing Practices (UCPMP) has been issued as guidelines for pharmaceutical and medical device companies to ensure ethical and transparent promotional activities. It places restrictions on interactions with medical practitioners and prohibits false or misleading claims and promotes off-label use of drugs or medical devices. Companies are also expected to accurately represent the intended use, performance, and safety profile of the device and disclose any potential risks or limitations associated with the device.

CONCLUSION

Based on the information covered, it is important to note that medical devices are subject to various regulations that apply to drugs, with some variance. Under the Medical Device Rules 2017, licensing and registration of medical devices are mandatory, and manufacturing, marketing, and distribution are governed under the Drugs and Cosmetics Act. The Quality Management Systems under MDR are specific to medical devices. However, the DPCO does not apply to medical devices, as it has not been notified as software by the NPPA. The Legal Metrology Act applies to labeling and packaging of medical devices, including software. It is important to keep in mind that advertising of medical devices is prohibited under the Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954, unless consent is taken from the DCGI, and it is only allowed for scientific journals. Additionally, it is important to follow the Uniform Code of Pharmaceutical Marketing Practices, which prohibits any unethical expenses on doctors for promoting any drug, including medical devices, such as hospitality, gifts, cash, or kind.

Annexure 1 – Licenses Required for Import, Sale, Manufacture and Loan of Medical Devices Under The MDR

License for or Registration Certificate Form (template) of the License Application form Relevant Rule Licensing Authority Timelines (from the date of application)
Import of Notified Medical Devices Form MD-15 Form MD-14 Rule 36(1) Central Licensing Authority 9 months
Import of Notified Medical Devices for clinical investigation Form MD-17 Form MD-16 Rule 41(1) Central Licensing Authority 30 days
Permission to import new Notified Medical Device for clinical trial or marketing Form MD-29 Form MD-28 Rule 64(2) Central Licensing Authority 90 days
Permission to conduct clinical investigation Form MD-25 Form MD-23 Form MD-24 Form MD-22 Rule 59(5) Rule 52(1) Central Licensing Authority 90 days
Permission to import or manufacture medical device that does not have a predicate device Form MD-27  Form MD-26 Rule 63(2) Central Licensing Authority 120 days
Retail sale of Notified Medical Devices Form 21  Form 19 Rule 61(2) State Drug Licensing Authority No time period prescribed (usually between three to six months)
Whole sale of Notified Medical Devices Form 21-B Form 19 Rule 61(2) State Drug Licensing Authority No time period prescribed (usually between three to six months)
License to manufacture Notified Medical Devices Form MD-5 for Class A or Class B Form MD-9 for Class C or Class D Form MD-3 for Class A or Class B Form MD-7 for Class C or Class D Rule 20(4) and 20(6) for Class A or Class B Rule 25(1) for Class C or Class D The State Drug Licensing Authority for classes A and B devices, Central Licensing Authority for Classes C and D devices 45 days from the date of application
License to manufacture a Notified Medical Device for Clinical investigation Form MD-13  Form MD-12 Rule 31(3) Central Licensing Authority 30 days
Loan License (manufacture in facility owned by third party) Form MD-6 for Class A or Class B Form MD-10 for Class C or Class D Form MD-4 for Class A or Class B Form MD-8 for Class C or Class D Rule 20(4) and Rule 20 (6) for Class A or Class B Rule 25(1) for Class C or Class D The State Drug Licensing Authority for classes A and B devices, Central Licensing Authority for Classes C and D devices 45 days