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Software As A Medical Device

NEW TGA Classification Rules for software

The TGA has proposed new classification rules for software based medical devices, including smart phone apps. This means that classification rules are now based on risk to individual or public health rather than the intended purpose.

In summary, very few software based devices will be class I.

Transition periods apply for those currently ARTG entered, otherwise new rules apply August 2020.

SPEAK TO US TODAY for further information

Contact us on:

@ gloizou@compliancems.com.au

0433124266

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TGA ARTG Medical Device Sponsorship

As per the Australian TGA Medical Device Regulations, before someone can supply a Medical device for sale in Australia they are required to make an application to include the item in the Australian Register Therapeutic Goods (ARTG). The sponsor is the person or company responsible for the importation of therapeutic goods into Australia.

If you are an overseas manufacturer of medical devices and you require Australian ARTG entry, let Compliance Management Solutions act as your sponsor. We aim to provide our customers with the highest level of service with an efficient and cost effective approach.

About CMS:

CMS is a service provider for the following:

Therapeutic Goods:

  • Australian TGA Sponsor for global Medical Device/Medicinal Product/IVD manufacturers
  • TGA Agent/Consultant for Australian Medical Device/Medicinal Product/IVD manufacturers and distributors
  • TGA GMP implementation and maintenance (Medicinal Products / API / Sunscreens), including training
  • TGA complimentary medicines indications evidence
  • TGA Therapeutic Goods Medical Device Regulations & ISO 13485 implementation and maintenance (Medical Devices including IVD’s), including training
  • FDA 510k/PMA/De Novo application preparation for medical devices and in vitro diagnostic products and maintenance in compliance with the 21 CFR Part 800
  • Technical File/Design Dossier preparation and maintenance in compliance with Council Directives – 93/42/EEC, MDR 2017/745, FDA 21 CFR Part 800 and Australian medical device Regulations
  • Technical File/Design Dossier preparation and maintenance in compliance with Council Directives –
  • 98/79/EC in vitro diagnostics, FDA 21 CFR Part 800 and Australian In Vitro Diagnostic Regulations
  • Medical Device/IVD Testing to International/Harmonized Standards (Active/Non-active)
  • 1st / 2nd / 3rd Party medical device/IVD auditor (EN ISO 13485 | IVD 98/79/EC | MDD 93/42/EEC  | MDR | MDSAP)
  • 3rd Party (certification) medical device Notified Body auditor (DQS/LRQA/TUV SUD)
  • 3rd Party (certification) medical device Technical File/Design Dossier reviewer (DQS/LRQA/TUV SUD)
  • International Authorised Representative (Australia, Europe, Vietnam, Singapore, Malaysia, NZ and more)
  • Risk Management ISO 14971 | ICH Q9

Cosmetics:

  • Cosmetics GMP ISO 22716 implementation and maintenance, including training
  • ISO 22716 1st /2nd / 3rd Party Audits
  • Cosmetics Label/Ingredients review for the Australian and International markets including Poisons/Schedule review
  • NICNAS Registration
  • AICS chemical substance database review
  • NICNAS Cosmetic Exemption (CE-1) and Secondary Notification
  • European/Global Production Information File (PIF) / Regulatory Dossier preparation and maintenance including safety assessment

Miscellaneous:

  • Integrated Management Systems implementation and maintenance (ISO 9001 / OH&S / ENV), including training and 1st /2nd / 3rd Party Audits
  • Implementation of Lean Six Sigma Methodologies
  • Equipment commissioning/installation and troubleshooting
  • Validation including process/equipment qualification/sterilization/packaging  
  • Continuous improvement activities including complaint handling investigations and corrective/preventive action
  • Risk Management (ISO 31000)

George Loizou | Director | MDD/MDSAP/MDR Notified Body/AO Lead Auditor | MDD/MDR Notified Body Technical File Reviewer |

C | M | SCompliance Management Solutions – Leaders In Compliance (Australia, Europe, Vietnam, Singapore, Malaysia, NZ)

M: +61 4 33 124266

E: gloizou@compliancems.com.au

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Medical Device Single Audit Program (MDSAP) – TGA, MDR, EU and more…………………………………….

Medical Device Single Audit Program (MDSAP) – TGA, MDR, EU and more…………………………………….

Achieve access to multiple markets with a single audit

The International Medical Device Regulators Forum (IMDRF) established a working group to develop a standard set of requirements for auditing organizations (Certification Bodies) performing regulatory audits of Medical Device manufacturers’ quality management systems. Termed the Medical Device Single Audit Program (MDSAP), the requirements will be applicable to regulatory authorities, as well as third-party organizations that conduct such audits.

What is MDSAP?

The objective of the MDSAP is to develop, manage, and oversee a single audit program that will allow a single regulatory audit of a Medical Device manufacturer, conducted by an MDSAP recognized auditing organization, to satisfy the needs of multiple regulatory jurisdictions.

How can CMS support you?

If you like to participate in the program please contact me for further information.

Regards,

George Loizou | Director | MDD/MDSAP/MDR Notified Body/AO Lead Auditor | MDD/MDR Notified Body Technical File Reviewer |

C | M | SCompliance Management Solutions – Leaders In Compliance (Australia, Europe, Vietnam, Singapore, Malaysia, NZ)

M: +61 4 33 124266

W: compliancems.com.au

E: gloizou@compliancems.com.au

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MDR 2017/745

GOODBYE GMDN………………          HELLO EMDN

The EMDN will be the nomenclature used when registering medical devices In the Eudamed database. Although mapped to the current GMDN Nomenclature, it is stand alone and will be used in future as a searching tool by EU Operators.

 

SPEAK TO US TODAY

Contact us on:

@ gloizou@compliancems.com.au

 +61 433 124 266

 Kew, Victoria

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MDR 2017/745 GOODBYE MDD………………….. WELCOME BACK MDD


                                                GOODBYE MDD…………………..          welcome back MDD………

With the commission proposing a postponement to the MDR until may 2021, it now may be possible to submit MEDICAL DEVICE CONFORMITY ASSESSMENT applications again under the mdd.

Which notified bodies will accept applications again under the mdd and which will not?

SPEAK TO US TODAY for further information or for a quote

Contact us on:

@ gloizou@compliancems.com.au

 +61 433 124 266

Melbourne, Victoria

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C | M | S GONE GLOBAL

Need TGA / European or Asian Medical Device Representation?

MEDICAL DEVICES LICENSE HOLDING / SPONSORSHIP / EC REPRESENTATION

Our latest service just launched and we’ve gone GLOBAL!

Check out our website for more information and quotation……………….via contact us. Compliance Management SolutionsMelbourne, Australia (Head Office)

E: gloizou@compliancems.com.au

M: +61 433 124 266

W: https://compliancems.com.au

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Cosmetics GMP for Export Purposes (ISO 22716) – Responsible Person

Cosmetics GMP for Export Purposes (ISO 22716) – Responsible Person

C | M | S can now act as your European responsible Person.

If you are a cosmetics exporter, you may have had been notified by mandated bodies that you require to comply with EC Regulation 1223/2009.

What are the requirements for this regulation?

All cosmetic products exported to Europe/Asia/NZ will have to be produced according to Good Manufacturing Practices.

Cosmetics Good Manufacturing Practices (GMP) is one of the pillars of the New European Regulation for Cosmetics. This regulation sets the requirements to ensure consumers’ safety. Amongst these new legal requirements, all cosmetic products circulating onto the European Market will have to be produced according to Good Manufacturing Practices; a Product Information File (PIF) is also required to demonstrate the cosmetic safety assessment.

This can be demonstrated by implementing ISO 22716.

Why implement Cosmetics Good Manufacturing Practices?

  • Comply with the new overseas legal requirements
  • Demonstrate to stakeholders (customers, retailers, importers etc) that your facility complies with GMP
  • Inspire consumers’ confidence
  • Ensure access to your markets  

For more information about the Cosmetics Regulation or for an obligation free quotation, please feel free to contact us.

E:  gloizou@compliancems.com.au

M: +61 4 3312 4266

W: https://compliancems.com.au

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TGA Australian Medical Device Sponsorship / License Holding

As per the Australian TGA Medical Device Regulations, before someone can supply a Medical device for sale in Australia they are required to make an application to include the item in the Australian Register Therapeutic Goods (ARTG). The sponsor is the person or company responsible for the importation of therapeutic goods into Australia.

If you are an overseas manufacturer of medical devices and you require Australian ARTG entry, let Compliance Management Solutions act as your sponsor. We aim to provide our customers with the highest level of service with an efficient and cost effective approach.

About CMS:

CMS is a service provider for the following:

Therapeutic Goods:

  • Australian TGA Sponsor for global Medical Device/Medicinal Product/IVD manufacturers
  • TGA Agent/Consultant for Australian Medical Device/Medicinal Product/IVD manufacturers and distributors
  • TGA GMP implementation and maintenance (Medicinal Products / API / Sunscreens), including training
  • TGA complimentary medicines indications evidence
  • TGA Therapeutic Goods Medical Device Regulations & ISO 13485 implementation and maintenance (Medical Devices including IVD’s), including training
  • FDA 510k/PMA/De Novo application preparation for medical devices and in vitro diagnostic products and maintenance in compliance with the 21 CFR Part 800
  • Technical File/Design Dossier preparation and maintenance in compliance with Council Directives – 93/42/EEC, MDR 2017/745, FDA 21 CFR Part 800 and Australian medical device Regulations
  • Technical File/Design Dossier preparation and maintenance in compliance with Council Directives –
  • 98/79/EC in vitro diagnostics, FDA 21 CFR Part 800 and Australian In Vitro Diagnostic Regulations
  • Medical Device/IVD Testing to International/Harmonized Standards (Active/Non-active)
  • 1st / 2nd / 3rd Party medical device/IVD auditor (EN ISO 13485 | IVD 98/79/EC | MDD 93/42/EEC  | MDR | MDSAP)
  • 3rd Party (certification) medical device Notified Body auditor (DQS/LRQA/TUV SUD)
  • 3rd Party (certification) medical device Technical File/Design Dossier reviewer (DQS/LRQA/TUV SUD)
  • International Authorised Representative (Australia, Europe, Vietnam, Singapore, Malaysia, NZ and more)
  • Risk Management ISO 14971 | ICH Q9

Cosmetics:

  • Cosmetics GMP ISO 22716 implementation and maintenance, including training
  • ISO 22716 1st /2nd / 3rd Party Audits
  • Cosmetics Label/Ingredients review for the Australian and International markets including Poisons/Schedule review
  • NICNAS Registration
  • AICS chemical substance database review
  • NICNAS Cosmetic Exemption (CE-1) and Secondary Notification
  • European/Global Production Information File (PIF) / Regulatory Dossier preparation and maintenance including safety assessment

Miscellaneous:

  • Integrated Management Systems implementation and maintenance (ISO 9001 / OH&S / ENV), including training and 1st /2nd / 3rd Party Audits
  • Implementation of Lean Six Sigma Methodologies
  • Equipment commissioning/installation and troubleshooting
  • Validation including process/equipment qualification/sterilization/packaging  
  • Continuous improvement activities including complaint handling investigations and corrective/preventive action
  • Risk Management (ISO 31000)

George Loizou | Director | MDD/MDSAP/MDR Notified Body/AO Lead Auditor | MDD/MDR Notified Body Technical File Reviewer |

C | M | SCompliance Management Solutions – Leaders In Compliance (Australia, Europe, Vietnam, Singapore, Malaysia, NZ)

M: +61 4 33 124266

W: compliancems.com.au

Posted on

Medical Device Single Audit Program (MDSAP) – TGA, MDR, EU and more…………………………………….

Medical Device Single Audit Program (MDSAP) – TGA, MDR, EU and more…………………………………….

Achieve access to multiple markets with a single audit

The International Medical Device Regulators Forum (IMDRF) established a working group to develop a standard set of requirements for auditing organizations (Certification Bodies) performing regulatory audits of Medical Device manufacturers’ quality management systems. Termed the Medical Device Single Audit Program (MDSAP), the requirements will be applicable to regulatory authorities, as well as third-party organizations that conduct such audits.

What is the MDSAP?

The objective of the MDSAP is to develop, manage, and oversee a single audit program that will allow a single regulatory audit of a Medical Device manufacturer, conducted by an MDSAP recognized auditing organization, to satisfy the needs of multiple regulatory jurisdictions.

How can CMS support you?

If you like to participate in the program please contact me for further information.

Regards,

George Loizou | Director | MDD/MDSAP/MDR Notified Body/AO Lead Auditor | MDD/MDR Notified Body Technical File Reviewer |

C | M | SCompliance Management Solutions – Leaders In Compliance (Australia, Europe, Vietnam, Singapore, Malaysia, NZ)

M: +61 4 33 124266

W: compliancems.com.au