The Australian Declaration of Conformity (DoC) for medical devices is a required document by both the Therapeutic Goods Administration (TGA)and the Australian Communications and Media Authority (ACMA).
The verbiage implies that products supplied to Australia or exported from Australia, comply with the Essential Principles (EPs), the classification rules as well as conforming to adequate conformity assessment procedures and related standards.
This applies to any device whether it is produced locally or intended to be imported to Australia. It makes the word ‘supplier’ an umbrella term that covers manufacturers, importers, wholesalers, or any other authorized representative.
In the context of the medical device pre-market registration procedure and post market approval process with the TGA, the regulatory body requires suppliers to have a DoC cover three main compliance aspects:
1. Compliance with EPs that are detailed in the Medical Devices Therapeutic Act and Regulations, anddivided into two main categories:
• General principles, applicable to all the devices. These are related to health and safety, including the long termsafety, the suitability of the device according to its intended purpose, the transport and storage requirements, and associated benefits/adverse effects .
• Design and construction principles that are specific to the intended purpose and properties of the medical device. Those specific principles are related to the chemical, physical and biological properties, infection and microbial contamination, construction and environmental properties, specificities if any measuring function, radiation, connection or inclusion of an energy source in the device, information to be provided with medical devices, and the clinical evidence.
2. Applicable classification rules.
3. Conformity assessment adequate procedures, which the manufacturer is responsible to choose and which relies on the classification level of the medical device. Indeed, TGA provides six templates and gives orientation about how to fill each one. There are some classes where several templates can be used alternatively depending on the classification rule used for the device to register.
ACMA is the second regulatory body involved in the conformity assessment of a medical device when it is under one of the following categories:
According to each category, ACMA gives direction about the compliance procedure, involving several steps.After showing compliance by submitting a labelling notice, identifying relevant technical standards and testing requirements and applying them to the medical device, suppliers are required to complete a DoC, in order to be able to register (or renew registration of) the device into the national database for one year. The supplier is then considered to be ‘responsible’. This step is also crucial in order to obtain the Regulatory Compliance Mark (RCM), which is an official label that proves that the medical device complies with the standard applied.
To note that the registration to the national database does not exempt suppliers from registration with other regulatory bodies such as the Electrical Regulatory Authorities Council (ERAC) to substantiate electrical safety, although the same database is used in this case.
After confirming compliance with adequate conformity assessment procedures, TGA issues certification while ACMA is responsible then to register the device in its national database where labels will require the inclusion of the Regulatory Compliance Mark (RCM). ACMA can also require any related documentation for potential audits.
The DoC grants several advantages for suppliers and the manufacturer.
Indeed, the sign off of the DoC by the manufacturer attests that associated products comply with the Essential principles. Additional conditions can refer to required notifications by the manufacturer to the supplier where substantial changes to the product are undertaken orwhere post market complaints and Adverse events are reported in geographies other than where the product is approved.
On the basis that the content of the TGA template is not inclusive, the document can also include a reference to not only the parent product but all associated approved variances of the same product with the same intended purpose. A tabular representation could have all respective catalogue numbers with Label and Instructions for Use as attachments, forming referenced approved materials as a cross check to product approved for supply.
The DoC is considered a powerful document committing both manufacturer and supplier to compliance requirements. The DoC, where additional inclusions of particular clauses in TGA provided templates, can be regarded as a contractual agreement duly signed by the importer and the manufacturer of the associate product.
RQSolutions (www.rqsolutions.com.au) services the global Therapeutic Goods Industry, with over 35 years’ expertise, in Sponsorship, TGA Registrations, PLAC related Government Reimbursement, ISO13485 based Quality Management and document management optimisation. We are based in Australia and a heartbeat away from our colleagues at the TGA. Let us share with you, the various available options to register your Medical Devices in Australia. We look forward to hearing from you to email@example.com
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