Medical Devices and IVDs

Athreva as a trusted regulatory partner can provide expertise for end-to-end regulatory services for medical devices. Industry experts at Athreva have the experience to support you navigate through the regulatory variabilities and local nuances across regions. Proactive regulatory support provides a company the benefit of having a clear understanding of device registration procedures for an efficient strategy for international expansion. We have experience in working for companies and aiding them in registering products with major global regulatory bodies like the USFDA, Europe’s Notified Bodies, and other leading regulatory bodies across regions

A simple deviation in the regulatory process can lead to unexpected costs, delay in market entry and divergence from regulatory compliance. With help of Athreva, you can pursue a full spectrum of regulatory services right from product design and development to post-market surveillance support across leading regulated markets. Our team comprises of seasoned professionals in the regulatory domain enabling Athreva to emerge as a one-stop-shop for any regulatory need. You can count on us for up-to-date and in-depth insights which increases your timely market entry.

Country Wise Medical Devices Regulatory Services :

  • A manufacturer who is willing to manufacture, import, sell or distribute medical devices in European Union (EU), should acquire or apply for relevant CE certification for that medical device. A CE mark accredits the medical device with the regulations laid and accepted by the EU and enables commercialization of the product in the European member states. In parallel, the manufacturer will be responsible for maintaining regulatory compliance QMS and making sure product is bearing the relevant CE mark. More Details

  • In the United States of America (USA), the Food and drug administration (FDA) controls and regulates the market access, entry, import, sales and use of medical devices, In vitro diagnostic (IVD) product and Software as a Medical device (SAMD). USFDA is one of the most regulated market for Medical Devices, IVDs and SAMD with proper, defined and pre-emptive registration pathways. More Details

  • Medical Devices market in the Middle East region is very distinct and displaying exceptional growth with substantial progress. Middle east regulations show certain level of homology with GHTF/IMDRF the grouping of Medical Devices is the manufacturer’s responsibility. More Details

  • Canada is one of the most regulated health authorities with updated regulation and governance allowing multiple and novel devices to be placed in the market. For new medical devices/IVDs Health Canada emerges as one of the early implementers of medical device regulations with several strong and robust regulatory requirements. More Details

  • With the increasing demand of effective care and patient management system, regulations are becoming stringent worldwide and the countries are moving toward updating their regulatory framework while making them unified. On similar lines, Indian medical device industry has evolved rapidly and is moving towards growing ‘regulated’. More Details

  • In Singapore, it is important to accurately classify the device before initiating the registration activities. The Health Science Agency (HSA) imposes different registration methods for each class based on their complexity and risk associated. Selecting the appropriate method is essential, as it can significantly affect costs, submission requirements, and even approval times.  More Details

  • Medical devices are separated into 5 classes: class I, class IIa, class IIb, class III, and Active Implantable Medical Devices (AIMD). Vitro diagnostic devices (IVD) are divided into four separate classes: class I, class II, class III, and class IV. More Details  

  • The Medical devices intended to be manufactured/ imported/ distributed in the region are regulated and governed by the Federal Commission for the Protection against Sanitary Risk (COFEPRIS). Located in proximity to the United states and Canada, Mexico has an expedited approval process for products already having a FDA and Health Canada clearance. More Details

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