Labeling is defined as the particular information associated with a device targeted to the end user or patient or lay caregiver. Medical device labeling helps patients or end users in understanding the device, its operation, care and maintenance. The medical device labeling also provides information about the way device interacts with the body to accomplish its purpose, its place and patient care and treatment program. Medical device labelling gives the adequate directions for operating the devices which are needed for safe and effective use. Basically, the medical device labeling is driven by the rules and regulations specified by the regulatory authority U.S. Food and Drug Administration (FDA). FDA has specified the sections based on the usage and applications of the devices.
The global medical device labeling market has expected to register the significant growth over the forecast period due to the increasing demand of end use market of medical devices which drives the global medical device labeling market. The increasing awareness about the need of information regarding device, its safety and effective usage also drives the growth of the global medical device labeling market. The U.S. Food and Drug Administration (FDA), the global regulatory body has specified some mandatory guidelines and regulations for the medical device labeling which also drives the global medical device labeling market.
However, as per the FDA guideline and regulations, maintaining the standardized format of labeling throughout the medical device industry has become difficult which could restrain the growth of the global medical device labeling market.
The global medical device labeling market is segmented on the basis of the code of federal regulations, type of medical devices, label position, packaging practices and geographical region.
Based on the type of medical devices, the global medical device labeling market is segmented into:
· Class I general controls
o With exemptions
o Without exemptions
· Class II general controls and special controls
o With exemptions
o Without exemptions
· Class II general controls and premarket approval
Based on the code of federal regulations, the global medical device labeling market is segmented into:
· General Device Labeling - 21 CFR Part 801
· In Vitro Diagnostic Products - 21 CFR Part 809
· Investigational Device Exemptions - 21 CFR Part 812
· Unique Device Identification - 21CFR Part 830
· Good Manufacturing Practices - 21 CFR Part 820
· General Electronic Products - 21 CFR Part 1010
Based on the packaging practices, the global medical device labeling market is segmented into:
· On device
· On packing
· Leaflet in the packing
Based on the label position, the global medical device labeling market is segmented into:
· Primary level of packaging
· Secondary level of packaging
In terms of geography, the global medical device labeling market has been divided into five key regions, including North America, Latin America, Europe, Asia-Pacific (APAC) and Middle East & Africa (MEA). The global medical device labeling market has expected to register a significant growth rate over the forecast period. North America has contributed the major share to the global medical device labeling market as the demand of ultimate end use medical device market is anticipated to grow across the forecast period. Europe is also growing at a decent growth and expected to register the significance CAGR over the forecast period due to the strict government regulations about medical device labeling. APAC is expected to register the healthy growth rate due to increasing healthcare facilities and increasing demand of medical devices. Latin America and MEA are at a nascent stage and anticipated to register the moderate growth rate over the forecast period in the global medical devices labeling market
Some of the key players of the global medical devices labeling market are SGS SA, Loftware Inc., UBM Canon, Quality Tech Services, Inc., Weber Packaging Solutions, Inc., Seagull Scientific, Inc., Master Control, Inc., Euro Plus, Registrar Corp and Pharmaceutic Litho & Label Company. Various global companies are contributing descent growth to the global medical device labeling market. The key players from North America are contributing major share to the global medical devices labeling in terms of value and volume.
Over all the global medical device labeling market has expected to register a significant growth over the forecast period.
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Last updated on: 12/10/2016
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