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Active dialogue with the ophthalmology community essential for approval process
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 Michael A. Lawless |
The phrase “the FDA is very interested in global harmonization” may at first glance seem similar to “I’m from the tax department, I’m here to help you.”
What are the facts regarding medical device registration in the Asia-Pacific region? In Australia, the process for registration of medical devices aligns closely with the European model. One difference is that there are no requirements in Europe for registration with government agencies, the process being largely conducted by third-party assessors, whereas in Australia, devices must be approved by a regulatory body, the Therapeutic Goods Administration (TGA).
As in Europe, the amount of data required is risk-based. For most class 1 and class 2 devices, an Australian company sponsor would submit data online to the TGA. This would include evidence that the manufacturer has been approved by a third-party assessor to manufacture the kind of device in question. If the TGA finds the data acceptable, it approves the device and includes it on the Australian Register of Therapeutic Goods.
As a result, class 1 and class 2 products that are CE marked can usually be quickly registered in Australia. A pupillometer is an example of a class 1 device.
Within class 2, there is a separate class, 2B, which includes most IOLs and some ophthalmic viscosurgical devices. Here, additional documentation needs to be submitted for audit before approval can be granted. This includes evidence of third-party assessment, clinical evidence, a checklist of compliance to the essential principles as defined by the TGA and a product risk analysis. This audit adds several months to the time for approval.
An additional hurdle applies to class 3 devices. This includes what the TGA describes as biologicals, such as sodium hyaluronate found in OVDs or the material in the STAAR Surgical Visian ICL. For these, the TGA must assess the evidence of conformity before approval, and this process can add at least a year to the approval time compared with Europe. It is expensive. The TGA operates under a 100% cost recovery scheme. It is fully funded from payments for initial registration and annual and audit fees. This cost is borne by companies and ultimately paid by consumers.
This has led to the situation in Australia in which the Visian ICL, although approved by the U.S. Food and Drug Administration, is only available in Australia under the Special Access Scheme (SAS). This means it is not TGA-approved, and the surgeon has to declare that there is no other treatment modality available for that individual patient. Contrast this with the Alcon AcrySof Caché phakic IOL, which is not FDA-approved but is TGA-approved. It does not require SAS approval and gives a level of comfort to both surgeon and patient in Australia.
The TGA has an effective post-mark surveillance function, which requires sponsors to report significant adverse events and device incidents.
As Malvina B. Eydelman, MD, of the FDA, notes in this month’s Cover Story, there was a meeting scheduled for September of the Asia-Pacific Economic Cooperation to look at global harmonization of medical device regulations.
Currently, most countries in the Association for South East Asian Nations do not have mandatory device registration, but the region is in the late stages of developing a Medical Devices Directory. The scheme may require submission and evaluation of a technical dossier for all new devices before registration, and although details have not been finalized, as currently proposed it is likely to lead to delays in availability of new device products in comparison to Europe and Australia.
The taxman may be well-meaning, and bureaucracies often are, but active engagement and dialogue with the ophthalmology community is essential to have sensible processes in place.