Medical Device Consultant, ISO 13485 Compliance, Australian TGA Medical Device Regulations, Regulatory Intelligence

Regulatory intelligence

Strategic regulatory decisions are critical in today’s hypercompetitive environment. Our comprehensive, extensive and up to date Regulatory Information System for all product approvals in Australia, will provide you with relevant, timely and in depth information required for exact and reliable decision making.

Minimise the possibility of a TGA rejection, reduce administrative time delays in reaching the correct decision with regards to correct GMDN codes and product classification. Access other approvals for an improved decision. Determine other manufacturers of similar products. Regulatory Information System has all that information.

We provide a one month free subscription to our Regulatory Intelligence database for all new TGA approvals. You will receive updated information by email by 9 am every Tuesday of every week for four weeks.

As an example for medical devices, we will include total details for manufacturers and sponsors, risk classifications with related GMDN codes applied by the sponsor and associated wording in the intended purpose used to gain TGA approval. Continual access to the Regulatory Intelligence network is by subscription.

This is unique to RQSolutions and related information can either be provided as an one –off service or part of on ongoing service to clients of RQSolutions As an example

As of January 2010, our system has information on more than 59,800 approvals. Of these, more than 27,000 relate to Medicines and the rest to Medical Devices. We note a total of 5,155 Medical Device Manufacturers. Of particular use is information of some 3,500 GMDN Codes that are obviously associated with the kind of product through its intended purpose.

Such data is an obvious benefit to companies already marketing their products in Australia or potential companies who are uncertain of the market place. Be prepared and let us assist you with the landscape on who’s who in Australia.