ICE POWER HLADNI SPREJ

Glavna informacija

  • Trgovački naziv:
  • ICE POWER HLADNI SPREJ
  • Razred:
  • IIa
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • Medicinski uređaj
  • Proizveden od:
  • Fysioline Pharma Oy, Finska

Dokument

  • za javnost:
  • Informativni letak za ovaj proizvod trenutno nije dostupan, možete poslati zahtjev na našu službu za korisnike, a mi ćemo vas obavijestiti čim smo u mogućnosti da ga dobiju.


    Zatražite informativni letak za javnost.

Lokalizacija

  • Na raspolaganju u:
  • ICE POWER HLADNI SPREJ
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Terapijska grupa:
  • brza njega povreda mekih tkiva i zbrinjavanje manjih opeklina

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • 381-08-30263
  • Datum autorizacije:
  • 13-01-2009
  • Zadnje ažuriranje:
  • 05-06-2018
  • Informativni letak za ovaj proizvod trenutno nije dostupan, možete poslati zahtjev na našu službu za korisnike, a mi ćemo vas obavijestiti čim smo u mogućnosti da ga dobiju.

    Zatražite informativni letak za javnost.

15-3-2019

Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on efforts to evaluate materials in medical devices to address potential safety questions

Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on efforts to evaluate materials in medical devices to address potential safety questions

The FDA is working to further evaluate materials like metals that are used in medical devices to learn more about how these materials interact with the immune system.

FDA - U.S. Food and Drug Administration

15-3-2019

Modification of the existing maximum residue level for fluopyram in broccoli

Modification of the existing maximum residue level for fluopyram in broccoli

Published on: Thu, 14 Mar 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer Hellas AG submitted a request to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance fluopyram in broccoli. The data submitted in support of the request were found to be sufficient to derive MRL proposals for broccoli. Adequate analytical methods for enforcement are available to control the residues of fluopyram on the commodit...

Europe - EFSA - European Food Safety Authority EFSA Journal

14-3-2019

FDA allows marketing of new device to help treat carbon monoxide poisoning

FDA allows marketing of new device to help treat carbon monoxide poisoning

FDA allows marketing of a new device, ClearMate, intended to be used with patients suffering from carbon monoxide poisoning. This is the first carbon monoxide poisoning device authorized for marketing by the FDA for use in an emergency room setting.

FDA - U.S. Food and Drug Administration

14-3-2019

FDA approves new indication for valve repair device to treat certain heart failure patients with mitral regurgitation

FDA approves new indication for valve repair device to treat certain heart failure patients with mitral regurgitation

Device is for treatment of patients to reduce mitral regurgitation in certain patients with heart failure symptoms who fail to respond to traditional therapy

FDA - U.S. Food and Drug Administration

1-3-2019

New EU report on big data paves the way for action

New EU report on big data paves the way for action

A taskforce on big data in the pharmaceutical area, the HMA-EMA Joint Big Data Taskforce, has just published its first report. The report offers a definition of big data and several recommendations for European authorities that regulate medicines and medical devices.

Danish Medicines Agency

26-2-2019

ICU Medical Issues a Voluntary Nationwide Recall of Certain Lots of ChemoLock™ and ChemoClave® Vial Spikes Due to the Potential for Burr Particulate

ICU Medical Issues a Voluntary Nationwide Recall of Certain Lots of ChemoLock™ and ChemoClave® Vial Spikes Due to the Potential for Burr Particulate

ICU Medical, Inc. today announced a voluntary recall of certain lots of ChemoLock™ and ChemoClave® Vial Spikes due to the potential for burr particulate originating from the protective cap used in the assembly of the device

FDA - U.S. Food and Drug Administration

26-2-2019

Annual Report of preparatory work on the toxicological studies and animal feeding studies performed under the EFSA contract OC/EFSA/GMO/2014/01, Lot 2 during the period 1/3/2017 to 27/11/2018

Annual Report of preparatory work on the toxicological studies and animal feeding studies performed under the EFSA contract OC/EFSA/GMO/2014/01, Lot 2 during the period 1/3/2017 to 27/11/2018

Published on: Fri, 22 Feb 2019 This report describes the tasks performed in the period 1/3/2017 to 27/11/2018 under the EFSA contract OC/EFSA/GMO/2014/01, Lot 2 on toxicological studies and animal feeding studies included in applications for market authorisation of genetically modified feed/plants under Regulation (EC) No 1829/2003. The tasks cover the check for study adherence to relevant EFSA guidance documents and to OECD Test Guideline no 407 (1995/2008), OECD Test Guideline no 408 (1998) and OECD P...

Europe - EFSA - European Food Safety Authority EFSA Journal

25-2-2019

FDA issues warning letter to clinic illegally marketing unapproved thermography device, warns consumers to avoid using thermography devices to detect breast cancer

FDA issues warning letter to clinic illegally marketing unapproved thermography device, warns consumers to avoid using thermography devices to detect breast cancer

FDA issues warning letter to clinic illegally marketing unapproved thermography device, warns consumers to avoid using thermography devices to detect breast cancer

FDA - U.S. Food and Drug Administration

25-2-2019

AEDs: How These Devices in Public Places Can Restart Hearts

AEDs: How These Devices in Public Places Can Restart Hearts

If cardiac arrest occurs, rapid treatment with a medical device called an automated external defibrillator, or 'AED' for short, can be life-saving. Learn how FDA works to help ensure they are safe and effective.

FDA - U.S. Food and Drug Administration

25-2-2019

For Women: The FDA Gives Tips to Prevent Heart Disease

For Women: The FDA Gives Tips to Prevent Heart Disease

Learn more about the safe and effective use of FDA-approved drugs and devices for the treatment and prevention of heart disease — the number one killer of women.

FDA - U.S. Food and Drug Administration

25-2-2019

FDA-Approved Devices That Keep the Heart Beating

FDA-Approved Devices That Keep the Heart Beating

Cardiovascular devices (or 'heart' devices) such as pacemakers and defibrillators have extended and improved the lives of millions of people worldwide. Learn how the FDA regulates these devices, when to seek medical attention for potential heart issues, and how to report problems.

FDA - U.S. Food and Drug Administration

22-2-2019

Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to spur development of innovative devices, including new advancements in novel brain implants, that can help patients with paralysis or amputation gain mobility

Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to spur development of innovative devices, including new advancements in novel brain implants, that can help patients with paralysis or amputation gain mobility

Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to spur development of innovative devices, including new advancements in novel brain implants, that can help patients with paralysis or amputation gain mobility

FDA - U.S. Food and Drug Administration

21-2-2019


Info day for micro, small and medium-sized enterprises (SMEs): regulatory toolbox for medicines and combined devices developers, European Medicines Agency, London, UK, from 26/10/2018 to 26/10/2018

Info day for micro, small and medium-sized enterprises (SMEs): regulatory toolbox for medicines and combined devices developers, European Medicines Agency, London, UK, from 26/10/2018 to 26/10/2018

Info day for micro, small and medium-sized enterprises (SMEs): regulatory toolbox for medicines and combined devices developers, European Medicines Agency, London, UK, from 26/10/2018 to 26/10/2018

Europe - EMA - European Medicines Agency

19-2-2019

Crown Chemical Products Inc. recalls Citrus Power Cleaner/Degreaser 4 L

Crown Chemical Products Inc. recalls Citrus Power Cleaner/Degreaser 4 L

The recalled product does not have the proper consumer chemical labelling required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

18-2-2019

Mang Luk Power Slim capsules

Mang Luk Power Slim capsules

Mang Luk Power Slim capsules pose a serious risk to your health and should not be taken.

Therapeutic Goods Administration - Australia

15-2-2019

Statement from FDA Commissioner Scott Gottlieb, M.D., on new policy to improve access and foster price competition for drugs that face inadequate generic competition

Statement from FDA Commissioner Scott Gottlieb, M.D., on new policy to improve access and foster price competition for drugs that face inadequate generic competition

FDA announces new draft guidance titled, Competitive Generic Therapies, to help provide even greater clarity to industry about the CGT pathway.

FDA - U.S. Food and Drug Administration

14-2-2019

FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices

FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices

FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices

FDA - U.S. Food and Drug Administration

14-2-2019

FDA issues warning letter to doctor for illegally marketing unapproved device with claims to prevent and treat tightening of scar tissue around breast implants

FDA issues warning letter to doctor for illegally marketing unapproved device with claims to prevent and treat tightening of scar tissue around breast implants

FDA issues warning letter to doctor for illegally marketing unapproved device with claims to prevent and treat tightening of scar tissue around breast implants

FDA - U.S. Food and Drug Administration

14-2-2019

Modification of the existing maximum residue levels for mandipropamid in various crops

Modification of the existing maximum residue levels for mandipropamid in various crops

Published on: Wed, 13 Feb 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Syngenta Crop Protection B.V. and Agriculture and Horticulture Development Board (AHDB) submitted, respectively, a request to the competent national authorities in the Netherlands and United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance mandipropamid in various crops. The data submitted in support of the request were found to be sufficient to derive MRL propo...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-2-2019

New data analysis centre to open at the Danish Medicines Agency

New data analysis centre to open at the Danish Medicines Agency

The Danish government today announced its decision to support the establishment of a new data analysis centre in the Danish Medicines Agency. The centre is to handle the analysis of large data quantities in the pharmaceutical and medical devices areas and will set new standards for the monitoring of the safety and efficacy of medicines and medical devices after their marketing.

Danish Medicines Agency

6-2-2019

Statement from Binita Ashar, M.D., of the FDA’s Center for Devices and Radiological Health on agency’s continuing efforts to educate patients on known risk of lymphoma from breast implants

Statement from Binita Ashar, M.D., of the FDA’s Center for Devices and Radiological Health on agency’s continuing efforts to educate patients on known risk of lymphoma from breast implants

Statement from Binita Ashar, M.D., of the FDA’s Center for Devices and Radiological Health on agency’s continuing efforts to educate patients on known risk of lymphoma from breast implants

FDA - U.S. Food and Drug Administration

1-2-2019

Stryker Launches Voluntary Field Action for Specific Units of the LIFEPAK® 15 Monitor/Defibrillator

Stryker Launches Voluntary Field Action for Specific Units of the LIFEPAK® 15 Monitor/Defibrillator

The company is notifying certain LIFEPAK 15 customers of an issue that may cause the device to lock up after a defibrillation shock is delivered. The lock-up condition is defined as a blank monitor display with LED lights on, indicating power to the device, but no response in the keypad and device functions. A device in this condition has the potential to delay delivery of therapy, and this delay in therapy has the potential to result in serious injury or death.

FDA - U.S. Food and Drug Administration

1-2-2019

FDA warns patients and doctors about recall of home-use test strips used with device to monitor blood thinner warfarin, not authorized for sale in U.S.

FDA warns patients and doctors about recall of home-use test strips used with device to monitor blood thinner warfarin, not authorized for sale in U.S.

Medical product distributor issued voluntary recall of certain Roche Diagnostics test strips used with CoaguChek test meter devices.

FDA - U.S. Food and Drug Administration

1-2-2019

Modification of the existing maximum residue levels for sulfoxaflor in various crops

Modification of the existing maximum residue levels for sulfoxaflor in various crops

Published on: Thu, 31 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dow AgroSciences submitted a request to the competent national authority in Ireland to modify the existing maximum residue levels (MRLs) for the active substance sulfoxaflor in various crops, including limes imported from Australia. The data submitted in support of the request were found to be sufficient to derive MRL proposals for limes, cauliflowers, Brussels sprouts, kales, spinaches and similar ...

Europe - EFSA - European Food Safety Authority EFSA Journal

28-1-2019

Statement from FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on a record year for device innovation

Statement from FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on a record year for device innovation

Review of 2018 device innovations, with record-setting 106 novel device approvals, and new actions FDA is taking to modernize approach to safety

FDA - U.S. Food and Drug Administration

23-1-2019

DKMA Update December 2018

DKMA Update December 2018

In this issue of DKMA Update you can read about safety for medical devices; new biosimilar medicines for Humira; better conditions for clinical trials in Denmark; new front page for our website and much more

Danish Medicines Agency

22-1-2019

PurpleAir recalls PowerStream power supplies for PA-II and PA-II-SD air quality sensors

PurpleAir recalls PowerStream power supplies for PA-II and PA-II-SD air quality sensors

PurpleAir has received reports of thermal events (arcing, sparking, smoking) originating in the power supplies. The thermal event is limited to the power supply and not PurpleAir’s air sensors, but the arcing, sparking, and smoking may pose a risk of fire if combustible material is near the power supply when it experiences a thermal event. Discoloration can result on the surface where a power supply is mounted.

Health Canada

22-1-2019

Modification of the existing maximum residue levels for aclonifen in celeriacs and certain fresh herbs

Modification of the existing maximum residue levels for aclonifen in celeriacs and certain fresh herbs

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Landesanstalt für Landwirtschaft und Gartenbau Sachsen‐Anhalt (LSA) and Dienstleistungszentrum Ländlicher Raum Rheinpfalz (DLR), respectively, submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRL) for the active substance aclonifen in chives, parsley, celery leaves/dill leaves, thyme/savoury and in celeriacs/turnip‐rooted celery. The ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

Modification of the existing maximum residue levels for aminopyralid in certain cereals

Modification of the existing maximum residue levels for aminopyralid in certain cereals

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dow AgroSciences Denmark submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance aminopyralid in cereals. The data submitted in support of the request were found to be sufficient to derive MRL proposals for barley, rye, sorghum, millet and oats. A modification of the existing MRL of aminopyralid in wh...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-1-2019

Modification of the existing maximum residue levels for spirotetramat in various crops

Modification of the existing maximum residue levels for spirotetramat in various crops

Published on: Fri, 18 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the competent national authority in Belgium prepared a request to modify the existing maximum residue levels (MRLs) for the active substance spirotetramat in Florence fennels and rhubarbs. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer SAS submitted a request to the competent national authority in Austria to modify the existing MRLs for spirotetramat in the group of ...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Setting of an import tolerance for spiromesifen in coffee beans

Setting of an import tolerance for spiromesifen in coffee beans

Published on: Mon, 14 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience submitted a request to the competent national authority in Greece to set an import tolerance for the active substance spiromesifen in coffee beans. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for coffee beans. Adequate analytical methods for enforcement are available to control the residues of spiromesife...

Europe - EFSA - European Food Safety Authority EFSA Journal

7-1-2019

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new actions under the Pre-Cert Pilot Program to promote a more efficient framework for the review of safe and effective digital health innovations

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new actions under the Pre-Cert Pilot Program to promote a more efficient framework for the review of safe and effective digital health innovations

FDA issues three documents that launch next phase of Pre-Cert Pilot Program to test new approaches for the review of digital health device applications.

FDA - U.S. Food and Drug Administration

20-3-2019

Q&A: Use of market authorisation evidence from comparable overseas regulatory bodies for medical devices

Q&A: Use of market authorisation evidence from comparable overseas regulatory bodies for medical devices

Additional Q&A's on use of market authorisation evidence from overseas regulatory bodies for medical devices

Therapeutic Goods Administration - Australia

15-3-2019

reviewers, compliance officers and other experts would work in teams responsible for device oversight throughout the product's development and  commercialization. This is known as a Total Product Life Cycle  approach or #TPLC.

reviewers, compliance officers and other experts would work in teams responsible for device oversight throughout the product's development and commercialization. This is known as a Total Product Life Cycle approach or #TPLC.

reviewers, compliance officers and other experts would work in teams responsible for device oversight throughout the product's development and commercialization. This is known as a Total Product Life Cycle approach or #TPLC.

FDA - U.S. Food and Drug Administration

15-3-2019

Rather than assessing a device only at one point in time—for instance, to evaluate whether a device meets the standard for approval, or to evaluate postmarket data involving a device safety signal—

Rather than assessing a device only at one point in time—for instance, to evaluate whether a device meets the standard for approval, or to evaluate postmarket data involving a device safety signal—

Rather than assessing a device only at one point in time—for instance, to evaluate whether a device meets the standard for approval, or to evaluate postmarket data involving a device safety signal—

FDA - U.S. Food and Drug Administration

15-3-2019

We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.  https://go.usa.gov/

We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S. https://go.usa.gov/

We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S. https://go.usa.gov/xE6Ws 

FDA - U.S. Food and Drug Administration

15-3-2019

#FDA CDRH is responsible for protecting and promoting the public health.  We assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products.  #MedicalDevice

#FDA CDRH is responsible for protecting and promoting the public health. We assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. #MedicalDevice

#FDA CDRH is responsible for protecting and promoting the public health. We assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. #MedicalDevice

FDA - U.S. Food and Drug Administration

6-3-2019

Today @US_FDA made an update to a Safety Communication on the Zoll LifeVest 4000 Wearable Cardioverter Defibrillator: Software Update for Potential Lack of Treatment (Shock) Delivery Due to Device Failure. Read more:  https://go.usa.gov/xEfkX  #MedicalDev

Today @US_FDA made an update to a Safety Communication on the Zoll LifeVest 4000 Wearable Cardioverter Defibrillator: Software Update for Potential Lack of Treatment (Shock) Delivery Due to Device Failure. Read more: https://go.usa.gov/xEfkX  #MedicalDev

Today @US_FDA made an update to a Safety Communication on the Zoll LifeVest 4000 Wearable Cardioverter Defibrillator: Software Update for Potential Lack of Treatment (Shock) Delivery Due to Device Failure. Read more: https://go.usa.gov/xEfkX  #MedicalDevice #FDA pic.twitter.com/WZZjTq0BMX

FDA - U.S. Food and Drug Administration

6-3-2019

Consultation: Proposed changes to the classification of medical devices used in direct contact with the heart, central circulatory or central nervous systems

Consultation: Proposed changes to the classification of medical devices used in direct contact with the heart, central circulatory or central nervous systems

This consultation paper considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification. Closing date: 29 April 2019

Therapeutic Goods Administration - Australia

6-3-2019

Consultation: Proposed new medical device classification for substances introduced into the body via a body orifice or applied to the skin

Consultation: Proposed new medical device classification for substances introduced into the body via a body orifice or applied to the skin

This consultation paper considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification. Closing date: 29 April 2019

Therapeutic Goods Administration - Australia

6-3-2019

Consultation: Proposed medical device classification for human cells, tissues and organs storage solutions and IVF media

Consultation: Proposed medical device classification for human cells, tissues and organs storage solutions and IVF media

This consultation paper considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification. Closing date: 29 April 2019

Therapeutic Goods Administration - Australia

6-3-2019

Consultation: Proposed new classification rule for medical devices that administer medicines or biologicals by inhalation

Consultation: Proposed new classification rule for medical devices that administer medicines or biologicals by inhalation

This consultation considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification. Closing date: 29 April 2019

Therapeutic Goods Administration - Australia

6-3-2019

Consultation: Proposed changes to the classification of active implantable medical devices and their accessories

Consultation: Proposed changes to the classification of active implantable medical devices and their accessories

This consultation considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification. Closing date: 29 April 2019

Therapeutic Goods Administration - Australia

28-2-2019

Today @US_FDA issued a safety communication to providers and patients  about the use of robotically-assisted surgical devices for mastectomy  and other cancer related surgeries. Read more here:  https://go.usa.gov/xEpub?utm_source=CDRHTwitterD …  #Medical

Today @US_FDA issued a safety communication to providers and patients about the use of robotically-assisted surgical devices for mastectomy and other cancer related surgeries. Read more here: https://go.usa.gov/xEpub?utm_source=CDRHTwitterD … #Medical

Today @US_FDA issued a safety communication to providers and patients about the use of robotically-assisted surgical devices for mastectomy and other cancer related surgeries. Read more here: https://go.usa.gov/xEpub?utm_source=CDRHTwitterD … #MedicalDevice pic.twitter.com/MitGy4EuFh

FDA - U.S. Food and Drug Administration

27-2-2019

Heart disease is the leading cause of death for U.S. men and women. And many #FDA regulated devices are used to treat various heart issues. Here’s how.  link:  https://go.usa.gov/xEprU?utm_source=CDRHTwitterD …   #heartmonthpic.twitter.com/i5IDrYgSLs

Heart disease is the leading cause of death for U.S. men and women. And many #FDA regulated devices are used to treat various heart issues. Here’s how. link: https://go.usa.gov/xEprU?utm_source=CDRHTwitterD … #heartmonthpic.twitter.com/i5IDrYgSLs

Heart disease is the leading cause of death for U.S. men and women. And many #FDA regulated devices are used to treat various heart issues. Here’s how. link: https://go.usa.gov/xEprU?utm_source=CDRHTwitterD … #heartmonth pic.twitter.com/i5IDrYgSLs

FDA - U.S. Food and Drug Administration

26-2-2019

TGA presentation: Stakeholder Workshop held in TGA, Symonston, 8 February 2019

TGA presentation: Stakeholder Workshop held in TGA, Symonston, 8 February 2019

This presentation highlights some of the concerns related to system or procedure pack medical devices.

Therapeutic Goods Administration - Australia

22-2-2019

A5: #FDA funds $6M/yr for the Pediatric Device Consortia Grants Program – a program to provide advice and support services to advance innovation in medical devices for children.  http://go.usa.gov/cpygz  #NIHChat

A5: #FDA funds $6M/yr for the Pediatric Device Consortia Grants Program – a program to provide advice and support services to advance innovation in medical devices for children. http://go.usa.gov/cpygz  #NIHChat

A5: #FDA funds $6M/yr for the Pediatric Device Consortia Grants Program – a program to provide advice and support services to advance innovation in medical devices for children. http://go.usa.gov/cpygz  #NIHChat

FDA - U.S. Food and Drug Administration

22-2-2019


Joint audit programme for European Economic Area good-manufacturing-practice inspectorates: Audit report template

Joint audit programme for European Economic Area good-manufacturing-practice inspectorates: Audit report template

Joint audit programme for European Economic Area good-manufacturing-practice inspectorates: Audit report template

Europe - EMA - European Medicines Agency

21-2-2019


EU and Switzerland to improve information-sharing on good manufacturing practice through use of the EudraGMDP database

EU and Switzerland to improve information-sharing on good manufacturing practice through use of the EudraGMDP database

EU and Switzerland to improve information-sharing on good manufacturing practice through use of the EudraGMDP database

Europe - EMA - European Medicines Agency

15-2-2019

#ICYMI: FDA authorizes first interoperable insulin pump intended to  allow patients to customize treatment through their individual diabetes  management devices. Read more here:  https://go.usa.gov/xEUuM   #MedicalDevice #FDA

#ICYMI: FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices. Read more here: https://go.usa.gov/xEUuM  #MedicalDevice #FDA

#ICYMI: FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices. Read more here: https://go.usa.gov/xEUuM  #MedicalDevice #FDA

FDA - U.S. Food and Drug Administration

15-2-2019

Today, the @US_FDA announced an upcoming General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting that will take place on March 25-26. Learn more about the details and how to attend here:  https://go.usa.gov/xEUeu  #Medi

Today, the @US_FDA announced an upcoming General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting that will take place on March 25-26. Learn more about the details and how to attend here: https://go.usa.gov/xEUeu  #Medi

Today, the @US_FDA announced an upcoming General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting that will take place on March 25-26. Learn more about the details and how to attend here: https://go.usa.gov/xEUeu  #MedicalDevice #FDA

FDA - U.S. Food and Drug Administration

14-2-2019

Today, the @US_FDA issued a warning letter citing safety concerns  regarding an illegally marketed device that claims to prevent and treat  tightening of scar tissue around breast implants. Read the more about  the warning letter here:  https://go.usa.gov

Today, the @US_FDA issued a warning letter citing safety concerns regarding an illegally marketed device that claims to prevent and treat tightening of scar tissue around breast implants. Read the more about the warning letter here: https://go.usa.gov

Today, the @US_FDA issued a warning letter citing safety concerns regarding an illegally marketed device that claims to prevent and treat tightening of scar tissue around breast implants. Read the more about the warning letter here: https://go.usa.gov/xEUks 

FDA - U.S. Food and Drug Administration

13-2-2019

Consultation: Regulation of software, including Software as a Medical Device (SaMD)

Consultation: Regulation of software, including Software as a Medical Device (SaMD)

The TGA is seeking feedback on how software, including Software as a Medical Device, is regulated in Australia. Closing date: 31 March 2019

Therapeutic Goods Administration - Australia

12-2-2019

Consultation: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices

Consultation: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices

The TGA is seeking feedback on how personalised medical devices are regulated in Australia. Closing date: 31 March 2019

Therapeutic Goods Administration - Australia

12-2-2019

Webinar: Regulation of Software as a Medical Device (SaMD)

Webinar: Regulation of Software as a Medical Device (SaMD)

This webinar provides an overview of how the TGA regulates medical devices, with a focus on SaMD products

Therapeutic Goods Administration - Australia

11-2-2019

Consultation: Proposed reclassification of spinal implantable medical devices

Consultation: Proposed reclassification of spinal implantable medical devices

This consultation paper considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification. Closing date: 31 March 2019

Therapeutic Goods Administration - Australia

8-2-2019

#ICYMI: Read the statement from Binita Ashar, M.D., of @US_FDA  's Center for Devices and Radiological Health on the agency’s continuing efforts to educate patients on known risk of lymphoma from breast  implants:  https://go.usa.gov/xERN3   #MedicalDevic

#ICYMI: Read the statement from Binita Ashar, M.D., of @US_FDA 's Center for Devices and Radiological Health on the agency’s continuing efforts to educate patients on known risk of lymphoma from breast implants: https://go.usa.gov/xERN3  #MedicalDevic

#ICYMI: Read the statement from Binita Ashar, M.D., of @US_FDA 's Center for Devices and Radiological Health on the agency’s continuing efforts to educate patients on known risk of lymphoma from breast implants: https://go.usa.gov/xERN3  #MedicalDevice #FDA

FDA - U.S. Food and Drug Administration

8-2-2019

Prescription medicine major variation: discretionary power to reduce fees in exceptional circumstances

Prescription medicine major variation: discretionary power to reduce fees in exceptional circumstances

In order to be eligible, sponsors need to meet all eligibility criteria.

Therapeutic Goods Administration - Australia

31-1-2019

TGA statutory advisory committees

TGA statutory advisory committees

New membership of Advisory Committee on Medicines, Advisory Committee on Medical Devices and Advisory Committee on Vaccines

Therapeutic Goods Administration - Australia

25-1-2019

ConvaTec Australia devices

ConvaTec Australia devices

Recall of multiple products - potential for breaches of sterile packaging

Therapeutic Goods Administration - Australia

11-1-2019

Consultation: Good Clinical Practice Inspections Program

Consultation: Good Clinical Practice Inspections Program

The TGA is seeking comments from interested parties on a pilot Good Clinical Practice (GCP) Inspections Program of 12 months duration that will inform a routine GCP Inspections Program. Closing date: 22 February 2019

Therapeutic Goods Administration - Australia

7-1-2019

Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia

Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia

The TGA is seeking your comments on the proposal to introduce new and amended definitions, and a revised scope of the products regulated as medical devices in Australia. Closing date: 18 February 2019

Therapeutic Goods Administration - Australia