Companies often come on a riddle when they intend to register their product in a region with higher ROI (return on investment) due to higher initial product registration process cost. At RQLogix we aim to assist our clients with optimum solutions to avoid regulatory submission pitfalls.
Most of the regulators / countries are accepting already registered products. These products are often low risk products and with increasing competition / low margin products. For higher classification and novel devices, the registration process require attention to detail and preparation, even these products are registered in overseas market. In the Australian market, they often get setback and face a lengthy registration process, if devices are selected for an application audit. Some class IIb devices and all class III devices require mandatory application audit.
Check our website to understand Australian regulatory requirements.
Our services are based on in-house highly knowledgeable professionals from the field of medical devices, pharmaceutical and biological sector.
We also pride our self in providing assistance to our clients with other regulatory avenues such as CE marking, EMA, US FDA, Health Canada and registration of products in New Zealand, Taiwan, Singapore, Japan and China.
Company’s Keywords:
2
medical devices
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2018
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