We have successful terminologies for medicines but medical devices have much greater variety and are inherently harder to describe. We need international standards for device terminology and identification on both the clinical side and for the supply chain.
Presentation: MMDR reform - Patient Implant Cards and Information LeafletsTGA Australia
The TGA has introduced a new regulatory requirement for manufacturers of implantable medical devices to provide patient implant cards and patient information leaflets with their devices. The implementation period starts from December 2018 for some devices and will apply to all implantable devices by December 2021. The TGA is engaging with health care systems to determine the best method of delivery of these resources to patients.
We have successful terminologies for medicines but medical devices have much greater variety and are inherently harder to describe. We need international standards for device terminology and identification on both the clinical side and for the supply chain.
Presentation: MMDR reform - Patient Implant Cards and Information LeafletsTGA Australia
The TGA has introduced a new regulatory requirement for manufacturers of implantable medical devices to provide patient implant cards and patient information leaflets with their devices. The implementation period starts from December 2018 for some devices and will apply to all implantable devices by December 2021. The TGA is engaging with health care systems to determine the best method of delivery of these resources to patients.
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...Akshay Anand
A presentation on Regulatory Approval Process for Medical Devices in European Union that explains in brief about the various aspects including the EU Medical Device Directives, Classifications, CE Certification, Medical Device Registration & Timelines. This was presented as a part of curriculum by Akshay Anand in JSS College of Pharmacy, Mysuru during January 2015
Changes in device classification under the EU Medical Devices and In Vitro Di...Erik Vollebregt
Presentation at the Q1 Intensive MDR/IVDR Readiness
and Transition Management Workshop about classification changes under the EU Medical Devices and In Vitro Diagnostic Regulation
The EU’s medical device regulation
Medical device manufacturers seeking market access
to the European Union (EU) will soon face major changes
in the EU’s decades-old regulatory framework. The EU’s
Medical Device Regulation (MDR) was officially published
on 5 May 2017 and came into force on 25 May 2017.
The MDR will replace the EU’s current Medical Device
Directive (93/42/EEC) and the EU’s Directive on active
implantable medical devices (90/385/EEC).
The new Medical Device Regulation Classification is changing with the (EU) 2017/745. I prepared an infographic and free forms to use to define if the class of your product changed. This Cheat Sheet is helping you to see a summary of each rule. Medical Devices are classified in 4 class from the one with lower risk to the one with higher risk. Each class is defining how you can get the CE mark of your product. Come and learn on easymedicaldevice.com how to be an expert on medical devices.
Tuv sud-ivdr-infosheet - EU’s In Vitro Diagnostic Medical Device RegulationStefano Bolletta
EU’s In Vitro Diagnostic Medical Device Regulation
A quick guide to the new IVDR.
The EU’s in vitro diagnostic medical device
regulation
Manufacturers of in vitro diagnostic medical devices
seeking market access to the European Union (EU)
will soon face major changes in the EU’s decades-old
regulatory framework. The EU’s In vitro diagnostic
medical device regulation (IVDR) was officially
published on 5 May 2017 and came into force on
26 May 2017. The IVDR will replace the EU’s current
directive on in vitro diagnostic medical devices
(98/79/EC).
Changing medical device regulations in Europe and the U.S.Maetrics
Topics covered at our recent ABHI (UK) event. Slides cover the reprocessing of single-use devices, the benefits of unique device identification, and supporting clinical evidence.
Medical Devices Rules 2017 Implementationshashi sinha
Medical Devices Rules are now enforced for all medical devices. It is important to know about the MDR 2017 and how it affects the Manufacturers, Importers and Distributors of Medical Devices and status of implementation.
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...Akshay Anand
A presentation on Regulatory Approval Process for Medical Devices in European Union that explains in brief about the various aspects including the EU Medical Device Directives, Classifications, CE Certification, Medical Device Registration & Timelines. This was presented as a part of curriculum by Akshay Anand in JSS College of Pharmacy, Mysuru during January 2015
Changes in device classification under the EU Medical Devices and In Vitro Di...Erik Vollebregt
Presentation at the Q1 Intensive MDR/IVDR Readiness
and Transition Management Workshop about classification changes under the EU Medical Devices and In Vitro Diagnostic Regulation
The EU’s medical device regulation
Medical device manufacturers seeking market access
to the European Union (EU) will soon face major changes
in the EU’s decades-old regulatory framework. The EU’s
Medical Device Regulation (MDR) was officially published
on 5 May 2017 and came into force on 25 May 2017.
The MDR will replace the EU’s current Medical Device
Directive (93/42/EEC) and the EU’s Directive on active
implantable medical devices (90/385/EEC).
The new Medical Device Regulation Classification is changing with the (EU) 2017/745. I prepared an infographic and free forms to use to define if the class of your product changed. This Cheat Sheet is helping you to see a summary of each rule. Medical Devices are classified in 4 class from the one with lower risk to the one with higher risk. Each class is defining how you can get the CE mark of your product. Come and learn on easymedicaldevice.com how to be an expert on medical devices.
Tuv sud-ivdr-infosheet - EU’s In Vitro Diagnostic Medical Device RegulationStefano Bolletta
EU’s In Vitro Diagnostic Medical Device Regulation
A quick guide to the new IVDR.
The EU’s in vitro diagnostic medical device
regulation
Manufacturers of in vitro diagnostic medical devices
seeking market access to the European Union (EU)
will soon face major changes in the EU’s decades-old
regulatory framework. The EU’s In vitro diagnostic
medical device regulation (IVDR) was officially
published on 5 May 2017 and came into force on
26 May 2017. The IVDR will replace the EU’s current
directive on in vitro diagnostic medical devices
(98/79/EC).
Changing medical device regulations in Europe and the U.S.Maetrics
Topics covered at our recent ABHI (UK) event. Slides cover the reprocessing of single-use devices, the benefits of unique device identification, and supporting clinical evidence.
Medical Devices Rules 2017 Implementationshashi sinha
Medical Devices Rules are now enforced for all medical devices. It is important to know about the MDR 2017 and how it affects the Manufacturers, Importers and Distributors of Medical Devices and status of implementation.
Explanation of how medical device information in the AccessGUDID web site will be used in Electronic Health Records NLM device manufacturers submit to the FDA is made available at the National from the National Library of Medicine.
A complete scenario of Medical Device Industry Of USA and India as well as of some major players. The presentation also highlights the Rules and regulations with respect to the devices and also SWOT analysis of emerging markets
On September 24, 2013, the U.S. Food and Drug Administration announced the new requirement to identify medical devices that affect its safe and effective use through the use of UDI. Explore on how Freyr can help medical device companies achieve UDI compliance.
As UDI deadlines roll out, OEMs are left with many questions on implementation and compliance, including:
How does FDA recommend we direct mark screws and small implants?
How should we proceed as we await the guidance on the Convenience Kit exemption?
What are best practices for entering submissions to GUDID?
How is FDA enforcing UDI?
FDA officials will speak on UDI adoption and UDI data quality. Bring your questions. Ample time will be saved for Q&A.
Devices Sponsor Information Day: 3A - Medical Devices - Manufacturer's eviden...TGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
“CFDA Registration – Market Access Before Investment” delivered by Tim Lin, T...ulmedical
Due to a large population, increasing middle class and government plans to build tens of thousands of hospitals, there is a lot of demand for high quality medical devices in China. For many foreign medical device manufacturers, the regulatory barriers are still significant obstacles.
The medical device regulation in China is less harmonized and generally unique from other major markets. The primary challenges tend to be: actual testing, drafting standards, language barriers and license parking. These additional requirements create a delay in the registration process.
Foreign manufacturers need to specifically understand the Chinese medical device regulation in advance, and then are able to determine appropriate strategies aimed at successful China market entry.
This is the content for a live webinar, "CFDA Registration, Market Access before Investment...Solving the CFDA Challenge" delivered by UL's Tim Lin. Tim is the Senior Technical Consultant working in the Greater China Region. He majored in public health and medical device engineering, and worked as a reviewer in the Taiwan FDA for high and moderate-risk medical device and clinical trial protocol for over 5 years; and also drafted guidance for industry. He is now responsible for risk management file, usability engineering, software validation and CE MDD technical documentation.
To comprehend the regulatory requirements to import medical Medical devices and authorization procedures in regulated markets of the United States and Australia
TGA changes for Medical Devices in AustraliaJoe Hage
http://MedicalDevicesGroup.net Sydney-based regulatory affairs expert Arthur Brandwood discusses the recent changes made by the Australian Therapeutic Goods Administration (TGA).
He also covers:
• Australia’s aggressive deregulatory agenda
• The Australian tax incentive (43.5% for R&D expenditure)
• The simple process for regulation of clinical trials in Australia
• TGA’s web based submission process for device approvals
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VISION
Being proactive
Supporting optimal animal and human health
Exploring ways to reduce overall use of antimicrobials
Using the drugs that prevent and treat disease by killing microscopic organisms in a responsible way
GOAL
to prevent the generation and spread of antimicrobial resistance (AMR). Doing so will preserve the effectiveness of these drugs in animals and humans for years to come.
being to preserve human and animal health and the effectiveness of antimicrobial medications.
to implement a multidisciplinary approach in assembling a stewardship team to include an infectious disease physician, a clinical pharmacist with infectious diseases training, infection preventionist, and a close collaboration with the staff in the clinical microbiology laboratory
to prevent antimicrobial overuse, misuse and abuse.
to minimize the developme
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6. New Zealand Health Strategy
Personal medical devices and wearables are options
for everyone who needs them
Our health system readily enables the uptake of new
technology
Electronic health records include medical device
information as core content
7. Medical devices
Orthopaedic implants, arterial stents, pacemakers and
prostheses
Wearables and home based monitors
Colostomy bags, catheters and other appliances
Wound care products
Peritoneal dialysis equipment and supplies
Diagnostic scanners and therapeutic nuclear medicine
machines
In vitro diagnostic devices and laboratory test equipment
Equipment such as hospital beds
10. New Zealand Medicines Terminology
Lists over 2400 approved medicines and 400 device
types
Based on SNOMED
NZULM adds funding details from the Pharmaceutical
Schedule and safety information
NZ Formulary further includes indications,
contraindications and cautions for clinical decision
support
11. New Zealand Medicines Terminology
Medicinal Product (MP)
paracetamol
Medicinal Product Unit of Use (MPUU)
paracetamol 500 mg tablet
Medicinal Product Pack (MPP)
paracetamol 500 mg tablet, 20
Trade Product (TP)
Panadol
Trade Product Unit of Use (TPUU)
Panadol 500 mg tablet: film-coated, 1
tablet
Trade Product Pack (TPP)
Panadol 500 mg tablet: film coated, 20
tablets
Containered Trade Product Pack
(CTPP)
Panadol 500 mg tablet: film-coated,
20 tablets, blister pack
13. associated morphology
finding site
fully specified name
preferred term
is a
physical product
pharmaceutical
disorder
living organism
substance
SNOMED is a network of clinical concepts
14. Unique Device Identifiers
Each manufactured item has a UDI, with two components
Device identifier (our standard is GTIN) indicates the
manufacturer and specific device type, including any options
Production identifier includes the batch number, expiry date
and serial number
15. Linking clinical and supply chain use
Unique Device Identifier (UDI)
Physical device identified for
supply chain purposes
Possibly many per CTPP
Device Terminology
Abstract medical device description representing
relevant clinical features
Containered Trade
Product Pack (CTPP)
Production Identifier
(PI) Batch number
Expiry date
Serial number
Device Identifier (DI)
GTIN
16. Universal list of medicines and devices
Unique Device Identifier (UDI)
Physical device identified for
supply chain purposes
Possibly many per CTPP
Device Terminology
Abstract medical device description representing
relevant clinical features
Containered Trade
Product Pack (CTPP)
Device Identifier (DI)
GTIN
Production Identifier
(PI) Batch number
Expiry date
Serial number
17. Device labels and barcodes
Unique Device Identifier (UDI)
Physical device identified for
supply chain purposes
Possibly many per CTPP
Device Terminology
Abstract medical device description representing
relevant clinical features
Containered Trade
Product Pack (CTPP)
Device Identifier (DI)
GTIN
Production Identifier
(PI) Batch number
Expiry date
Serial number
18. Electronic health records
Unique Device Identifier (UDI)
Physical device identified for
supply chain purposes
Possibly many per CTPP
Device Terminology
Abstract medical device description representing
relevant clinical features
Containered Trade
Product Pack (CTPP)
Device Identifier (DI)
GTIN
Production Identifier
(PI) Batch number
Expiry date
Serial number
19. Alerting example
Patient in hospital for management of recurrent venous ulcers
Recorded diagnosis of congestive heart failure
Clinician begins to prescribe compression hosiery
Contraindication alert is raised
Patient also has recorded latex allergy
Nurse scans wound care products before use
Allergy alert is raised
20. Product recall example
Electronic health record documents each device dispensed to
a patient, including both the clinical device description from
the terminology and the UDI for the physical product
Any adverse events involving a device are captured in the
electronic health record
A safety issue is raised and a given batch of a product is
recalled
Health providers query the electronic health record to identify
the patients affected and make contact with them
21.
22. 1. Use GTIN as the supply chain device identifier
23. 2. Support international efforts to develop a common
UDI standard using GTIN as device identifier
24. 3. Support the international project to develop a
SNOMED based device model and terminology
26. 5. Record GTIN and other UDI data elements in
electronic health records for device traceability
27. 6. Extend NZULM to devices and use it to master the
linkage between the SNOMED based device
terminology and GTIN as device identifier
28. 1. Use GTIN as the supply chain device identifier
2. Support international efforts to develop a common
UDI standard using GTIN as device identifier
3. Support the international project to develop a
SNOMED based device model and terminology
4. Implement a SNOMED based device terminology
5. Record GTIN and other UDI data elements in
electronic health records for device traceability
6. Extend NZULM to devices and use it to master the
linkage between the SNOMED based device
terminology and GTIN as device identifier
29.
30. Published direction on medical device terminology
and identification standards
Benefits for patients, health providers, industry
partners, regulators, funders and purchasers
The same proven international standards for
devices as medicines
You can use the standards now
Work with us on implementation
Editor's Notes
Let’s implement medical device terminology and identification standards for value and high performance in the health system
This new publication provides direction on the required information standards for precise and consistent description and identification of medical devices in New Zealand
The essential requirements are captured in six directives
These are standards that manufacturers, sponsors, Medsafe, PHARMAC, district health boards and health providers all need to follow
Ultimately the standards benefit patients by helping to ensure the safety and performance of medical devices
Our solution addresses both medical device terminology and medical device identification in a harmonious way
I work for … health provider, manufacturer, software company, standards or the greater good
Don’t talk to me about … deep learning, AI, convergence, disruption
SNOMED or SNOWMED … SNOWMED, SNOMED, SNOMED CT, ICD 10
Health apps are like devices … not really, most certainly, and should be regulated, or at least star rated
The ‘I’ in GTIN stands for … identifier, identification, item, Internet
My LinkedIn connections are … all well known to me, mostly complete strangers, more quantity than quality, probably not even all human
SNOMED CT and GS1 Standards are the two key international standards that we adopt
