For the manufacture, import, and distribution of medical devices in India, companies must understand the regulatory procedures not only for the primary medical devices but also for the crucial components that support and enhance their functionality – the accessories. While accessories might seem like secondary items, they play a vital role in the effective and safe use of medical devices. Therefore, alongside the primary medical device, accessories are also regulated in India under the Drugs and Cosmetics Act, 1940, as notified through the S.O. 648 (E) dated February 11, 2020, issued by the Ministry of Health and Family Welfare. This signifies that accessories are subject to the same regulatory framework that applies to other medical devices in India.
To gain a deeper understanding of what constitutes accessories, how to register them, and other pertinent information, continue reading this blog.Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.
What are accessories to medical devices?
An ‘Accessory’ means a device which can be added to a primary medical device to make it more useful, versatile, or attractive. According to the notification S.O. 648 (E), an accessory shall be specifically intended by its manufacturer to be used together (in combination) with a particular medical device (parent) to enable or assist that medical device (parent) to be used in accordance with its intended use. Therefore, it is considered a separate item, and manufacturers are required to register it independently.
What are the examples of accessories to medical devices?
Few examples of accessories to medical devices include:
- CPAP/BPAP nasal/face mask
- SpO2 sensor
- Temperature Probes
- Blood Pressure Cuffs
- Adapters for surgical devices
- X-ray cassettes
- Bone screws or plates (used with implants)
- Pacemaker leads
- Electrosurgical unit electrodes and cables
- Cochlear implant magnets
- Trocar and cannula
- 3 way stop cock & Y-Connector for perfusion sets
- Casting tapes/Splint Rolls
- Printer for X-ray devices
- Extension tubes
- Nerve stimulator probes
How to register an accessory?
The process to register accessories to medical devices in India is same as that for medical devices themselves, as accessories fall under the definition of “medical devices” according to Notification S.O. 648(E) dated February 11, 2020. Therefore, they must be registered under the Drugs and Cosmetics Act, 1940, and the Medical Device Rules, 2017.
For a step-by-step guide on obtaining the registration certificate, check out our blog: “A Guide to CDSCO Medical Device (incl. IVDs) Registration”.
Why You Need an Expert to Navigate the Accessories Certification Process:
The Accessories Certification process often requires specialized knowledge of complex regulations. Therefore, an expert can efficiently guide you through the requirements, documentation, and submission stages, accelerating the process. This guidance can help you avoid costly mistakes and delays by ensuring accurate and thorough adherence to all requirements.
How Regulatory Solutions India Can Help You?
Regulatory Solutions India (RSI), established in 2011, specializes in providing end-to-end regulatory support to medical devices and IVDs manufacturers and importers worldwide. We assist in navigating the complex CDSCO regulatory landscape to ensure smooth registration and market entry of medical devices, IVDs, and their accessories in India. Our services include the preparation and submission of all required documentation, ensuring compliance with CDSCO standards.
With a deep understanding of Indian regulatory requirements, RSI can be your trusted partner in achieving timely and successful product registration and commercialization in the Indian market. Visit us to learn more.
