ITB HOLDINGS LLC | 390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | United States
+1 855-510-2240

Medical Devices

MEDICAL DEVICES MARKET

The global medical devices market size is expected to gain momentum by reaching $657.98 billion by 2028 from $455.34 billion in 2021.

Market segments include orthopedic devices, cardiovascular devices, diagnostic imaging, in vitro diagnostic, minimally invasive surgery, wound management, diabetes care, ophthalmic devices, dental devices, nephrology, general surgery, and others.

The increasing geriatric population is promoting demand for ophthalmic and orthopedic devices, as these help in reducing impaired vision and hip fractures in the elderly population. According to the World Health Organization, the number of individuals aged 60 and more is expected to reach nearly 2.0 billion in 2050.

Artificial intelligence (AI) helps healthcare professionals improve patient outcomes, reduce costs, increase efficiency, monitor patients remotely via sensors and automate therapy delivery using mobile apps.

Significant advancements in new technologies such as smart gadgets, and other lightweight communication devices are driving medical equipment. Sensors and medical equipment connected to 5G have near-zero latency, allowing them to gather and transfer data almost instantly.

North America’s dominance is predicted to continue. In the United States, there are over 6,500 medical device companies, the majority of which are small and medium-sized enterprises (SMEs).

DESPITE THE OVERALL TRADE DOWNTURN, MEDICAL GOODS TRADE EXPERIENCED PHENOMENAL GROWTH IN 2020

DEVICES

VALUE

All medical products (USD million) $1,159,674 (+16.1%)
Medical equipment $150,985 (+7.2%)
Ventilators $13,944 (+73.5%)
Medical supplies $204,391 (+18.5%)
Test kits & diagnostic reagents $39,249 (+39.4%)
Medicine $603,226 (+10.4%)
Personal protective products $201,071 (+44.2%)
Face masks $136,257 (+76.6%)

There are also shortages of raw materials for manufacturing, including semiconductors, or chips used in electronic devices and medical robotics.

Imports & Exports Regulations

Before you export your medical device to the United States, register your company with the U.S. Food and Drug Administration, to avoid the detention of your shipment.

Diagnostic tests, ventilators, and personal protective equipment (PPE), including surgical masks, face shields, respirators, gowns, and gloves, are regulated as medical devices.

Sunglasses, spectacle frames, spectacle lens, and magnifying spectacles are medical devices exempt from the Premarket Notification 510(k) submission to the FDA. However, additional requirements apply.

1

FDA Registration

2

Product Listing

3

Medical Device Reporting (MDR)

FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by chemical, biological, radiological, and nuclear (CBRN) threat agents, when certain criteria are met, including there are no adequate, approved, and available alternatives.

The FDA regulates surgical masks and surgical N95 respirators differently based on their intended use.

Which N95 respirators are not exempt from Premarket Notification 510(k)?

  • intended to prevent specific diseases or infections
  • labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity
  • contains coating technologies unrelated to filtration (reduce and or kill microorganisms).
327

    Diagnose heart attacks in minutes using a portable device
    Emergency Use Authorizations for Medical Devices
    Editors’ Picks
    Editors’ Picks
    Video News
    Video News