Product Compliance
Product Compliance
Know Your Medical Device Better – From Confusion to Clarity
What is medical device?
“Medical device” as per Medical Device Rules, 2017 means an instrument, apparatus, appliance, material, or other article which is used for diagnosis, prevention, monitoring, treatment, or alleviation of a health condition
"In vitro diagnostic medical device" means a medical device, which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended to be used in vitro for the examination of specimens derived from the human body solely or principally to provide information for diagnosis, monitoring or compatibility purposes.
“Predicate device” means a device, first time and first of its kind, approved for manufacture for sale or for import by the Central Licensing Authority and has the similar intended use, material of construction, and design characteristics as the device which is proposed for license in India.
Classification, Compliance and More
Classification of Medical Devices
Under the Medical Device Rules (MDR), 2017, implemented by the Central Drugs Standard Control Organization (CDSCO), medical devices in India are classified into four risk-based categories: Class A, B, C, and D. This classification is determined by the level of risk associated with the device’s intended use, ranging from low risk (Class A) to high risk (Class D).
- Class A devices - low risk
- Class B devices - low to moderate risk
- Class C devices - moderate to high risk
- Class D devices - high risk
Medical Device Classification in India
Accurate classification is essential to determine the appropriate regulatory requirements, documentation, and clinical evaluation needs under the Medical Device Rules, 2017. At Move Ahead, we provide expert guidance to ensure your devices are correctly classified according to their intended use, duration of contact, and invasiveness, enabling a smooth licensing process with the central regulatory authority. Our in-depth knowledge of the MDR framework helps you avoid costly delays and ensures full compliance from the start.
Applicable Indian Regulations for Medical Devices & IVDs
Medical devices and IVDs in India are regulated through a few key regulations
The medical device must comply with the specifications and standards established by the Bureau of Indian Standards (BIS) under the Bureau of Indian Standards Act, 1985 or any standards issued by the MoHFW or any other standards of quality and safety, applicable to it under the Medical Device Rules (MDR), 2017.
Medical Devices Rules (MDR), 2017: The Medical Devices Rules, 2017 classify medical devices and IVDs into four risk-based categories. These rules outline the procedures for import license applications (Form MD-14 / MD-15), registration of manufacturing sites and products, labelling requirements, and clinical investigations.
Legal Metrology (Packaged Commodities) Rules, 2011: These rules govern the labelling of packaged medical devices, including mandatory declarations such as price format, customer care contact details, and other consumer-related information.
Bureau of Indian Standards (BIS): Certain categories of medical devices may require mandatory certification under BIS standards, depending on the device type. Adherence to IS/ISO standards may be necessary for product registration or import licensing.
From Step One to Full Compliance – We are with you
- Appropriate product categorization
- Identifying predicate medical devices to justify waiver of clinical investigation
- Comprehensive Evaluation of Product Documentation
- Ensure up-to-date compliance with the regulations
Captcha:
Move Ahead at a Glance
Years of Experience
Employees
Happy Clients
Projects
Our Clients
