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

Medical Device Single Audit Program (MDSAP) – TGA 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
Compliance Management Solutions
E: gloizou@compliancems.com.au | M: +61 4 3312 4266
W: compliancems.com.au

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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:

Cosmetics:

  • Cosmetics GMP ISO 22716 implementation and maintenance, including training
  • ISO 22716 1st /2nd Party Audits
  • Cosmetics Label review for 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

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 Therapeutic Goods Medical Device Regulations & ISO 13485 implementation and maintenance (Medical Devices including IVD’s), including training
  • Technical File/Product Dossier preparation and maintenance in compliance with Council Directives – 93/42/EEC Medical Devices
  • Technical File/Product Dossier preparation and maintenance in compliance with Council Directives – 98/79/EC in vitro diagnostics
  • Medical Device Testing to International/Harmonized Standards (Active/Non active)
  • 1st /2nd Party Audits
  • Risk Management ISO 14971 | ICH Q9

Miscellaneous:

  • Integrated Management Systems implementation and maintenance (ISO 9001 / OH&S / ENV), including training
  • 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)
Compliance Management Solutions
Melbourne, Australia

E: gloizou@compliancems.com.au

M: +61 433 124 266

W: https://compliancems.com.au

Posted on

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:

Cosmetics:

  • Cosmetics GMP ISO 22716 implementation and maintenance, including training
  • ISO 22716 1st /2nd Party Audits
  • Cosmetics Label review for 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

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 Therapeutic Goods Medical Device Regulations & ISO 13485 implementation and maintenance (Medical Devices including IVD’s), including training
  • Technical File/Product Dossier preparation and maintenance in compliance with Council Directives – 93/42/EEC Medical Devices
  • Technical File/Product Dossier preparation and maintenance in compliance with Council Directives – 98/79/EC in vitro diagnostics
  • Medical Device Testing to International/Harmonized Standards (Active/Non active)
  • 1st /2nd Party Audits
  • Risk Management ISO 14971 | ICH Q9

Miscellaneous:

  • Integrated Management Systems implementation and maintenance (ISO 9001 / OH&S / ENV), including training
  • 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)
Compliance Management Solutions
Melbourne, Australia

E: gloizou@compliancems.com.au

M: +61 433 124 266

W: https://compliancems.com.au

Posted on

Cosmetics GMP for Export Purposes (ISO 22716)

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

Posted on

MDSAP – Medical Device Single Audit Program

Medical Device Single Audit Program (MDSAP) – TGA

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
Compliance Management Solutions
E: gloizou@compliancems.com.au | M: +61 4 3312 4266
W: compliancems.com.au

Posted on

MDSAP – Medical Device Single Audit Program

Medical Device Single Audit Program (MDSAP) – TGA

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
Compliance Management Solutions
E: gloizou@compliancems.com.au | M: +61 4 3312 4266
W: compliancems.com.au