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BG4313 GLOBAL MD REGULATORY OVERVIEW
Transcript of BG4313 GLOBAL MD REGULATORY OVERVIEW
Registration and Timeline
Timeline and Registration Strategy
Current Global Statistics
Global Diabetic Patient Statistics
ISO required for CE
Definition and Classification
ISO Required for FDA
Countries with highest rate of Diabetes cases?
Exploration of Product
Definition of Combination Product
Introduction of Product
Usage of Product
Timeline and Registration
CE approval marking process
FDA approval marking process
Quality Management Systems
Requirements for regulatory purposes
Application of risk management to medical devices
Clinical investigation of medical devices for human subjects
EN ISO 7864:1996
Sterile hypodermic needles for single use
clinical testing: nomenclature for components, cleanliness, limits for acidity and alkalinity, size designation, colour coding, needle hub, sheath, needle tube, needle point, performance, packaging, labelling, storage container, transport wrapping.
EN ISO 11608-5:2012
Needle-based injection systems for medical use
Clinical testing: for the administration of medicinal products in humans eg. needle preparation, air removal, priming, dose setting, actuation, needle insertion, injection of the medicinal product, needle retraction, needle removal
EN ISO 21649:2009
Needle-free injectors for medical use- Requirement & test metho
clinical testing:safety and performance and testing requirements for single-use and multiple-use needle-free injection systems intended for human use in clinics and other medical settings and for personal use by patients.
EN ISO 15747:2011
Plastic containers for intravenous injections
clinical testing: safe handling and the physical, chemical and biological testing of plastic containers for parenterals
EN ISO 23908:2013
Sharps injury protection
ISO 23908 (1st Edition - 2011)
Sharps injury protection
Clinical Testing: Ensure that the plungers does not impede or adversely affect the intended clinical performance.
ISO 11608-2 (2nd Edition - 2012)
Needle-based injection systems for medical use -Part 2: Needles
Clinical Testing: Mechanical testing of the pen injector needles
ISO 11040-4(2nd Edition-2012)
Syringes -part 4: Glass barrels for injectables
Clinical Testing : ensure that the dimensions, thickness or barrel neck curvature reach the criteria.
ISO 11608-3 (2nd Edition-2012)
Needle based injection systems for medical use - Part 3: Finished containers
Clinical Testing: To ensure dimensional accuracy of the cartridge in relation to the accuracy of dosage and compatibility with other components
ISO 11040-5 (3rd Edition - 2012) : SyringesPart 5: Plunger stoppers for injectable
Clinical Testing: How long can it function by doing mechanical testing.
Europe has approximately 50 % of US expenditure!
Japan Registration Process
EU registration Process
FDA Registration Process
Define combination product
Classifications for FDA and CE
Test required for compliance approval
Understand registration process for EU and FDA
Explored steps and timeline for both registration
Explored possible Pmda timeline and registration
Explored number of diabetic patient in Europe and US
Understand the medical expenditure for Europe and US
Explored potential Japan route
ISO 11608 (2nd edition- 2012) :
Needle-based injection systems for medical use - Part 1: Needle-based injection systems
Clinical Testing: To investigate the dosage precision of a pen injector after different types of conditioning.
Pmda approval marking process
Directive MEDDEV 2.1/3 Essential
Clearance will be given with 510(k) number
Register medical device and company online at FDA website
Will need U.S. Agent to be liaison contact with FDA since home office in Singapore
Substantially Equivalent (SE) 510(k): K063151
No need clinical trial data
“HUMAPEN LUXURA HD”
Code of Federal Regulations 21CFR880.5570
Classification: Hypodermic single lumen needle Class II
FDA 510(k) criteria
“Me-too”/Generic Device: Substantially equivalent with predicate device
HumaPen LUXURA (Eli Lilly)
no clinical trials needed
composed of two or more regulated components
eg. Drug/device , that are
physically, chemically combined
or mix and produced as a
A drug ,
or biological product
that according to processed labelling is intended for use only with an approved individually specified drug, device or biological product where
both are required to achieve the intended use, indication or effect
Any instrument, apparatus whether
used alone or in combination
, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purposes of: diagnosis, prevention, monitoring, treatment or alleviation of disease; and investigation, replacement or modification of the anatomy or of a physiological process, control of conception, and which does not achieve its
principal intended action
in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
There is no specific definition on combination products in legal term.