Manufacturers' evidence for medical devices
Fact sheet no. 17
September 2009
This Fact Sheet includes the following information (as amended September 2009):
- Who is responsible for submitting manufacturers' evidence?
- Who is the manufacturer as defined in the Therapeutic Goods Act 1989 (the Act)?
- What is meant by manufacturers' evidence?
- Legislative basis for manufacturers' evidence
- The types of certifications to submit as manufacturers' evidence
- What to look for on a European Commission (EC) and an EC-Mutual Recognition Agreement (MRA) Certificate used as manufacturers' evidence
- Submitting a TGA Conformity Assessment Certificate as manufacturers' evidence
- Submitting manufacturers' evidence via TGA's on line eBusiness services (eBS) system
- Maintaining currency of manufacturers' evidence
- Variations to existing manufacturers' evidence
- Reviewing variations to manufacturers' evidence
- The information to be submitted with a variation to manufacturers' evidence
Who is responsible for submitting manufacturers' evidence? (updated September 2009)
The Sponsor of a medical device is the person or company responsible for submitting the manufacturers' evidence notifications and applying to the TGA to have their medical device included in the ARTG. The sponsor is legally responsible for the medical devices and must be a resident of Australia or be an incorporated body in Australia and conducting business in Australia. Under the Act a sponsor is someone who:
- Imports therapeutic goods; or
- Manufacturer's therapeutic goods; or
- Exports therapeutic goods from Australia; or
- Has therapeutic goods exported, imported or manufactured on their behalf.
Who is the manufacturer as defined in the Therapeutic Goods Act 1989 (the Act)?
The manufacturer of a medical device is defined under section 41BG of the Act as the person who is responsible for the design, production, packaging, labelling and assigns the intended purpose for the device.
The manufacturer will hold the Conformity Assessment Certifications and display his/her name and address on the information provided with the medical device (ie product labels and instructions for use). The manufacturer may not necessarily be the person who undertakes the actual manufacture of the device. In some cases this could be performed by sub-contract manufacturers.
What is meant by manufacturers' evidence?
Manufacturers' evidence (also known as conformity assessment evidence) refers to the various certifications the Australian sponsor obtains from the manufacturer and submits to the TGA to demonstrate the manufacturer has:
- Implemented an appropriate quality management system for the manufacture of kinds of medical devices; and
- Applied the appropriate conformity assessment procedures to demonstrate the medical devices conform to the Essential Principles for safety and performance.
Please note:
- The process for receiving, reviewing, accepting and maintaining manufacturers' evidence applies to certifications issued by Notified Bodies as well as those Conformity Assessment Certificates issued by the TGA.
- Manufacturers' evidence is not required to be submitted pre-market for the lowest risk Class I medical devices that are supplied non-sterile and/or do not have a measuring function.
Legislative basis for manufacturers' evidence
| Section of the Act | Legislative provision | Purpose |
|---|---|---|
| Section 41F |
Kinds of medical devices can be included in the ARTG if:
|
Reviewing and accepting manufacturers' evidence provides the TGA with evidence that the requirements have been met, before the medical devices are included on the Australian Register of Therapeutic Goods (ARTG). |
| Section 41FD |
The person submitting an application to include medical devices on the ARTG must certify that:
|
The TGA acceptance of the manufacturers' evidence:
|
| Reg 3.5(1) | Allows for medical devices manufactured outside Australia to have their conformity assessment procedures certified by a body that the Secretary is satisfied has the authority and expertise to undertake that function. | This provision has allowed the TGA to "authorise" Notified Bodies to issue EC Certificates and approve European Conformity Assessment Bodies to issue Conformity Assessment Certificates to European manufacturers under the Australian- European Mutual Recognition Agreement (MRA). |
| Section 41FN(3) |
A condition of inclusion on the ARTG is that at all times while the device is included in the ARTG, the sponsor has:
|
Maintaining currency of the manufacturers' evidence provides confidence that:
|
| Section 41FC(1)(a) | This provision of the Act indicates an application for a kind of medical device "be made in accordance with a form approved by the Secretary". | Under this provision the form (ie manner) includes the submission of a notification form and a copy of the manufacturer's certification issued by a recognised Notified Body. |
The types of certifications to submit as manufacturers' evidence
The TGA will consider the following types of certification as manufacturers' evidence:
For medical devices other than Class I medical devices that are supplied non-sterile and/or do not have a measuring function:
- Certificate issued by a European Notified Body to an overseas manufacturer under the European Medical Devices Directive 93/42/EEC; or
- TGA Conformity Assessment Certificate issued by the TGA; or
- Certificate of conformity issued under the EC-MRA by a recognised European Conformity Assessment Body to a European manufacturer.
Please note:
Some devices are excluded from the EC-MRA agreement <http://www.tga.gov.au/international/ecmra.htm>
Some devices are required to hold TGA certification: Medical devices containing materials of animal, microbial or recombinant origin (draft) (pdf,97kb) <http://www.tga.gov.au/devices/argmd-dranimal.pdf>
For Active Implantable medical devices
- Certificate issued by a European Notified Body to an overseas manufacturer under the European Active Implantable Medical Devices Directive 90/385/EEC (specific to active implantable medical devices); or
- TGA Conformity Assessment Certificate issued by the TGA.
Procedure packs - limited cases
- A Manufacturers' Australian Declaration of Conformity under Schedule 3, Part 7.5 Therapeutic Goods (Medical Devices) Regulations 2002. Can be utilised under specific circumstances for the assembly of a procedure pack/or system (eg first aid kit) using ready made therapeutic goods.
- The template for the manufacturers' Declaration of Conformity for procedure packs/or system under Schedule 3 Part 7.5 is in Guidance Document 5 The Declaration of Conformity <http://www.tga.gov.au/docs/html/devguid5.htm>.
For Invitro diagnostic devices
- Certificate issued by a European Notified Body to an overseas manufacturer of invitro diagnostic devices under the European Invitro Diagnostics Devices Directive 98/79/ EC; or
- An International Standards Organisation (ISO) 13485 certificate from a recognised Notified Body. For further information on Acceptable evidence of good manufacturing practice (GMP) for IVDs <http://www.tga.gov.au/devices/ivd-evidence.htm> visit the TGA website.
Certifications not considered as manufacturers' evidence
The following certifications are not acceptable and should not be submitted to the TGA as manufacturers' evidence:
- Manufacturer's Declaration of Conformity (DoC) other than Schedule 3 Part 7.5 for procedure packs/systems. Other DoC's may be requested at the device application stage by the TGA assessor.
- A certification issued by the US Food and Drug Administration (FDA) is not acceptable because the US and Australian regulatory requirements do not align.
- An International Standards Organisation (ISO) 13485 compliance certificate is not acceptable for medical devices (other than IVDs) because this certificate only covers the quality systems and does not provide evidence that the device conforms to the Essential Principles.
- Test certificates issued by testing facilities demonstrating compliance with an ISO standard are not acceptable as the do not demonstrate the manufacturer has the required quality system or applied the required conformity assessment procedures.
- Design Examination Certificates, or Type Examination Certificates are not acceptable as Manufactures Evidence. These certificates relate to the medical device and may be requested at the device application stage for review as part of the pre-market assessment of the medical device.
What to look for on an EC and MRA certificate
It is essential that the correct certificate, including the relevant attachments are submitted as manufacturers' evidence. Should the information not be correct or an incorrect certificate submitted, the TGA will not accept the certificate. The following details should be present on the certificate and checked by the sponsor prior to submitting to the TGA.
Example 1 - Details to look for on an EC Certificate
Note: This is an example only. Wording and formatting will vary between Notified Bodies.
Please note:
Read certificate carefully and ensure any attachments are included. The attachments could be in the form of an MDD product list; Addendum; Annex; Appendix, Schedule or see overleaf.
Annex or Schedule to an EC Certificate
Determining the appropriate European Conformity Assessment Procedure for the class of device
The table below has been provided to assist sponsors to check the appropriate conformity assessment procedure (expressed as Annex) on the EC certificate is appropriate for the classification of the medical device.
| Classification | Options | Directive |
|---|---|---|
| Class 1 Measuring |
|
93/42/EEC |
| Class 1 Sterile |
|
93/42/EEC |
| Class IIa |
|
93/42/EEC |
| Class IIb |
|
93/42/EEC |
| Class III |
|
93/42/EEC |
| AIMDs and their accessories |
|
90/385/EEC |
Example 2 - Details to look for on a MRA Certificate
Determining the appropriate MRA or TGA Conformity Assessment Procedure for the class of device
The table below has been provided to assist sponsors to check the conformity assessment procedures on the MRA certificate are:
- appropriate for the classification of the device; and
- are in accordance with the Australian requirements under Schedule 3 of the Therapeutic Goods (Medical Devices) Regulations 2002.
| Classification | Options | Legislative reference |
|---|---|---|
| Class 1 Measuring |
|
|
| Class 1 Sterile |
|
|
| Class IIa |
|
|
| Class IIb |
|
|
| Class III and AIMD |
|
|
Submitting a TGA Conformity Assessment Certificate as manufacturers' evidence
The TGA Conformity Assessment Certificate is issued to the manufacturer by the TGA and is held by the manufacturer. Further information regarding TGA Conformity Assessment Certificates is available in Guidance Document 3 Conformity Assessment Procedures <http://www.tga.gov.au/docs/html/devguid3.htm>.
The manufacturer then appoints an Australian sponsor to supply the devices to the Australian market. The Australian sponsor must obtain a copy of the TGA Conformity Assessment Certificate from the manufacturer and submit to the TGA as manufacturers' evidence.
Once the manufacturers' evidence is accepted, the Australian sponsor must then submit the device application to the TGA quoting the Manufacturers Evidence ID number.
Please note:
The Australian manufacturer may choose to also be the Australian sponsor.
The sponsor's process for submitting the TGA Conformity Assessment Certificate to the TGA is a separate process to the manufacturer obtaining the TGA Conformity Assessment Certification.
Submitting manufacturers' evidence via eBs
Creating an e-business account
Before making an application, the Australian sponsor or an authorised person acting on behalf of the sponsor must be a client of the TGA. This is achieved by establishing an eBusiness account with the TGA. This provides access to the TGA's eBusiness System, which is used to make electronic applications for medical devices. The forms and instructions are at https://www.ebs.tga.gov.au.
Submitting a new notification for manufacturers' evidence
- Open eBusiness Home page on the internet at https://www.ebs.tga.gov.au
- Click on secure login
- Type in the eBusiness account name and password
- Click on the Portal
- Click on create applications and submissions
- Click on manufacturers evidence
- Complete all the fields in the new notification form and attach the appropriate certificate (a unique manufacturers evidence reference ID number will be created. Ensure all fields are complete and include the GMDN Codes and classification for all the devices which will be the subject of future device applications
- Once the form is completed, click on validate (check all fields are completed; are correct and the appropriate document is attached)
- Click on submit
- Once approved this manufacturers' evidence reference number will be used by the sponsor in future device applications and ARTG inclusions
Please note:
- Once the manufacturers' evidence is accepted by the TGA, the evidence will be stored under "Accepted Medical Devices Evidence" in the eBS menu.
- The unique manufacturers' evidence ID number remains unchanged.
- As a general rule, sponsors will select this manufacturers' evidence ID number in subsequent applications for medical devices sourced from this manufacturer and covered by the scope of the certificate.
- Design Exam Certificates and Type Exam Certificates are not submitted as manufacturers' evidence. These certificates may be requested at the device application stage.
Please note: (updated September 2009)
If the sponsor experiences difficulties in selecting the manufacturer (name and or address) from the drop down menu in the manufacturers' evidence notification form, please contact the TGA on 1800 141 144 (option 1 manufacturers evidence) or email cab.medical.device.information@tga.gov.au
Maintaining currency of manufacturers' evidence
Expired certificates (updated September 2009)
In most cases the manufacturers' certifications are current for 5 years from the last date of inspection. The expiry date as stated on the certificate is shown on the ARTG inclusion. Once a certificate expires, the sponsor is required to submit and updated certificate as a variation to existing evidence.
Variations to existing manufacturers' evidence (as amended September 2009)
The information on the manufacturers' certificates may change over time and as a consequence the Notified Body will generally audit the facility and/or issue a revised certificate.
These revised certificates are submitted to the TGA as a variation to previously approved manufacturers' evidence. Any changes to the certifications need to be incorporated in the variation notification form in eBS. The variation will be reviewed to determine if the details are acceptable.
Changes to existing manufacturers' certificates
The information on existing manufacturers' certificates which can change over time includes:
- Amending the range of products covered under the scope of the certificate
- Updating the certificate number following reissuing of a certificate
- Updating the expiry date following a surveillance audit and reissue of the certificate
- Altering the conformity assessment procedures (change to the annex route)
- Changing the Notified Body undertaking the audit, or
- Amending the manufacturers' details (name and/or address).
Any of these changes to the manufactures certificate needs to be updated on the existing manufacturers' evidence. The process for updating this information is to submit a variation to manufacturers' evidence via the online eBS System.
Submitting a variation to manufacturers' evidence
- Open the eBusiness Home page on the internet at https://www.ebs.tga.gov.au
- Click on secure login
- Type in the eBusiness account name and password
- Click on Accepted Medical Device Evidence
- Open the manufacturers evidence which needs to be updated
- Click on Create Variation and wait for confirmation that variation has been created
- Close manufacturers evidence
- Go to View Drafts located under the portal on the secure web view page of eBusiness Services
- Open manufacturers evidence and make the required amendments
- Attach copy of the re-issued certificate and any other supporting documents
- Validate the variation, and
- Click on submit.
Please note:
Sponsors must attach a document to the manufacturers' evidence to enable the notification to validate. Ensure all attachments to the certificate are included.
Reviewing variations to Manufacturers' Evidence (updated September 2009)
The TGA reviews the content of an EC certificates against the minimum requirements recommended by the Co-ordination of Notified Bodies Medical Devices (NB-MED) directive NB-MED/2.5.1/Rec4 for the minimum content of mandatory certificates.
This is explained earlier in this fact sheet: What to look for on an EC Certificate
When a reissued Certificate is submitted to the TGA, the TGA will compare the reissued certificate with the previous version of the certificate. Any differences are then considered in relation to possible consequences for existing ARTG inclusions. The differences of most concern include:
- Different manufacturers name and/or address (affects the definition of kind of device under section 41BE of the Act)
- Reduction on the conformity assessment procedures applied by the manufacturer (existing ARTG inclusions, particularly for the higher classified devices, may no longer be manufactured according to the required conformity assessment procedures)
- Reduction in the scope (range) of products covered by the certification (existing ARTG inclusions may no longer be manufactured under a quality system or to the required conformity assessment procedures)
- EC certificates submitted to replace an existing MRA certificate.
1. Amendment to the name of the existing manufacturer (updated September 2009)
The TGA recognises that there may be situations when a manufacturer may amend its name but all other aspects remain unchanged. There is no change of manufacturer, quality management system, conformity assessment procedures or devices supplied under existing ARTG inclusions.
In this situation, the TGA will consider a variation to manufacturers' evidence to amend the name of the manufacturer associated with existing ARTG entries. However, before making the amendment, the TGA will require additional documentation to verify the amendment is in relation to the existing manufacturer and not a change of manufacturer.
There are three key pieces of information which can help verify who the manufacturer is, under the Therapeutic Goods Act 1989, section 41BG and determine whether the amendment can be made to the manufacturer's details which will affect existing ARTG records:
- The details about the name manufacturer on the EC certificate
- The records held by the Notified Body who undertook the review and/or issued the revised EC Certificate as a result of the amendment to the manufacturers details, or
- Documentation from the manufacturer explaining the amendment to the name
If the manufacturer is considered to be a different person for the purposes of section 41BG(1) of the Act and the devices are manufactured under a new manufacturer this would be considered a different kind of device under section 41BE of the Act and would require new manufacturers' evidence, new medical device application(s) and with subsequent new ARTG inclusion(s).
Please note:
If the name change is due to a change of manufacturer, do not submit a variation to existing manufacturers' evidence. This requires new manufacturers' evidence, new device applications and new ARTG inclusions.
If the name or address of the manufacturer has been amended, the sponsor will need to attach documentation to verify whether the amendment is in relation to the existing manufacturer or represents a change of manufacturer.
2. Change to the Manufacturer's address (updated September 2009)
A similar situation occurs when the TGA is notified of a manufacturer's change of address. The TGA require additional documentation from the Notified Body and/or manufacturer to verify the change in address is in relation to the existing manufacturer. The key question for clarification is:
- Has the manufacturer re-located to a new address? or
- Is this new address an additional site?
If this address is a re -location the Client records held by TGA are updated to reflect the new address information.
If this is an additional site, the question to be clarified is whether this site operates under its own CE certificate and QMS (ie is responsible for the devices it designs, manufactures, packages, labels and supplies under its own name). If this is the case, the manufacturer at this new site is a different manufacturer for the purposes of section 41BG of the Act. A new manufacturer's evidence and new device application will be required and the new address will be added to the same CLIENT Id.
Please note:
If the new address is an additional site operating under its own EC certificate, do not submit a variation to existing manufacturers' evidence. This is likely to be a new Client, new manufacturer's evidence, new device applications and new ARTG inclusions.
2. Reduction in the conformity assessment procedures (updated September 2009)
If the conformity assessment procedures (annex route) stated on the updated EC certificate has been reduced from the previous certificate, the TGA may require confirmation from the sponsor to clarify whether devices supplied under existing ARTG inclusions are still adequately covered by the reduced conformity assessment procedures.
3. Reduction of scope on Certificate (updated September 2009)
If the scope of product(s) referenced on the Certification has been reduced from the previous certificate, the TGA may require confirmation from the sponsor to clarify whether devices supplied under existing ARTG inclusions are still adequately covered by the scope of the certificate.
4. MRA Certificates replaced by an EC Certificate (updated September 2009)
A MRA certificate signifies the manufacturer has been assessed for and met the Australian regulatory requirements. The certification is considered equivalent to a TGA Conformity Assessment Certificate and the device application is processed accordingly.
An EC certificate, however, signifies compliance with the European Medical Devices Directive. Given there are similarities between the European and Australian requirements, the TGA will take an EC Certificate into consideration as part of a pre-market assessment of the device for compliance with the Australian requirements.
If an MRA certificate issued to support a device application for inclusion on the ARTG, the TGA will expect the subsequent updated certificates to also be issued Under the EU-MRA.
The information to be submitted with a variation to manufacturers' evidence (updated September 2009)
The following table outlines documentation to be submitted with a notification to support the types of variations to existing manufacturers' evidence.
| The variation | Supporting documents required | Rationale |
|---|---|---|
| Add GMDN Code or class | Ensure that the of current certificate scope supports the new GMDN code and or the Annex route supports the new Class of device | A TGA business rule requires a document to be attached to the manufacturers' evidence form to enable validation |
| Change issue certificate number | Copy of the re-issued certificate | Verify certificate number |
| Update the certificate re-issue date | Copy of the re-issued certificate | Verify the re-issue date and check the revised date is in the dd/mm/yy format |
| Update the certificate expiry date | Copy of the re-issued certificate | Verify the revised expiry date and check the revised date is in the dd/mm/yy format |
| Change to the scope of products on the certificate | Copy of the re-issued certificate | Verify the change in scope of the certificate and ensure products included on the ARTG are still covered by the revised scope of the certificate |
| Change to the conformity assessment procedures | Copy of the re-issued certificate | Verify the change in procedures and ensure products included on the ARTG are still covered by the revised conformity assessment procedures |
| Change of Notified Body | Copy of the re-issued certificate | Verify the change in Notified Body and ensure the new auditing Body is a recognised Notified Body under the relevant European Council Directive |
| Amend the name of the existing manufacturer (as amended September 2009) |
Copy of the re-issued certificate + Documentation from the Notified Body that issued the amended certificate verifying whether the amended name of the manufacturer is considered to be the same manufacturer as defined under Article 1(f) of the European Medical Devices Directive 93/42/EEC. Letter from the manufacturer explaining the reasons for the amended name. |
It's important to establish whether the amendment to the name of the manufacturer is due to a simple name amendment or represents a change of manufacturer. The definition of a manufacturer under section 41BG(1) of the Act is the same as the definition under Article 1(f) of the European Medical Devices Directive 93/42/EEC. The change can affect the definition of a separate kind of device under section 41BE of the Act resulting in illegal supply of existing product. |
| Change of address of the manufacturer (as amended September 2009) |
Copy of the re-issued certificate + Documentation from the manufacturer to verify whether this is a relocation or an additional site. If this is an additional site, also require documentation from the Notified Body to verify whether this new site is considered to be a different manufacturer under Article 1(f) of the European Medical Devices Directive 93/42/EEC. |
If the manufacturer has relocated to a new site, the address is updated in the TGA's CLIENT database which will update all ARTG records for products sourced from the manufacturer. If the new address is an additional site operating under its own separate EC certificate, it is likely to be a different manufacturer. The new address will be added to the existing CLIENT Id and a new manufacturers' evidence, device application and ARTG entry will be required for product sourced from the new site. |