Medical Device Definition

To serve as guidance for Regulatory Authorities, Conformity Assessment Bodies and the regulated Industry, the Global Harmonization Task Force – GHTF developed the document “Definition of the Terms ‘Medical Device’ and ‘In Vitro Diagnostic (IVD) Medical Device’”.¹

‘Medical device’ means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:

diagnosis, prevention, monitoring, treatment or alleviation of disease,

diagnosis, monitoring, treatment, alleviation of or compensation for an injury,

investigation, replacement, modification, or support of the anatomy or of a physiological process,

supporting or sustaining life,

control of conception,

disinfection of medical devices,

providing information by means of in vitro examination of specimens derived from the human body;

and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means.

“In Vitro Diagnostic (IVD) medical device” means a medical device, whether used alone or in combination, intended by the manufacturer for the in-vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes.

The Harmonized Commodity Description and Coding System, also known as the Harmonized System (HS) of tariff nomenclature is an internationally standardized system of names and numbers to classify traded products. The HS System is maintained by the World Customs Organization and used by customs authorities around the world to identify products when assessing duties and taxes and for gathering statistics.

The HS assigns specific six-digit codes for varying classifications and commodities. Countries are allowed to add longer codes to the first six digits for further classification.

The file available below includes the list of HS codes used by the global medical technology sector for medical devices (first 6 digits), as well as the additional digits as used for medtech in the United States (HTS code).

These codes are required for the export and import of medical devices as well as to track related notifications on the technical regulations of such products to the World Trade Organization – Technical Barriers to Trade Committee.

HS and HTS codes for Medical Devices

REGULATORY COALITION PRINCIPAL MEMBERS