It is vitally important that a manufacturer decides on a strategy for all potential product markets before commencing the quality system and product approval process. A good strategy can avoid duplication of effort and gain synergy from the different regiemes, but not having a strategy is sure duplication of effort and extra cost and delay in getting to market. Contact Us
Some countries have always had their own requirements for Medical Devices, while others have adopted either the U.S. or E.U. system. Very few countries have a sizeable Healthcare market and no regulation - even the ones that have, usually have a few restrictions that complicate matters! For example: Hong Kong does not currently have any approval process for medical devices, but does have one for a drugs - this includes any kit containing a drug, so even a sterile wipe included in a kit will render the whole kit subject to the approval process!
The U.S. system was for many years the most advanced system of device regulation in the world - possibly it still is, it is certainly the one that is most heavily invested in by governement. The open-ness of the U.S. system made it very easy to copy and adapt. Some countries build their system on the U.S. model, even accepting U.S. 510(k) as evidence of the acceptability of a device.
The problem with the U.S. system is that it requires significant investment from government to operate, and by enshrining control regulations and classification in law is not flexible to a rapidly evolving market.
The EU system is the substantive base for the Global Harmonization Task Force (GHTF) model, currently being propergated by the International Medical Device Regulators Forum (IMDRF)
In recent years, the GHTF system has proved a very seductive model for governments wanting to better regulate Medical Devices without a major on-going investment. The methodology means that the need to get regular updates through the legislature is minimal. The size of the Authority that has to be funded by the government is fairly minimal as nearly all the work is sub-contracted out to Notified Bodies and paid for by industry.
Whether this model really provides the same level of assurance for the patient and clinician as the U.S. one is still open to dispute; that it can work if industry and NB's behave responsibly and it is extreemly cost effective seems proven.
There remains a great diversity of Regulatory Regiemes, and whether unique, or based on one of the two large models (U.S. or E.U./GHTF/IMDRF) there are significant differences between each and every country. It is vital to step back at the outset of any project, assess the requirements of all markets holistically and plan an integrated program of testing, submissions/approvals and follow-up to minimize duplication. The order of market entry often flows from regulatory process rather than any marketing desire, consequently the regulatory strategy needs to be integrated with the business plan. Those who work alone, treat each market as a discrete project and are led by events ... will have a long, painful and expensive lesson!