The medical device industry is strictly regulated in most of the major markets all around the world. AWAK Technologies will ensure all its products are designed, developed, manufactured and distributed in all markets complying with all applicable regulatory requirements. The regulations and statutes most relevant to AWAK Technologies are as follows:
ISO 13485 – Medical Devices, Quality Management Systems
ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization. AWAK Technologies was certified for ISO 13485 systems by SGS in September 2008.
Food and Drug Administration (FDA), United States
Within the U.S. FDA, the Center for Devices and Radiological Health is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States.
Medical devices are classified into Class I, II, and III under the FDA system. Generally, regulatory control increases from Class I to Class III. Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); and most Class III devices require a more comprehensive review process, which is the Premarket Approval (PMA).
AWAK Technologies targets to apply the 510(k) clearance path to obtain the marketing approval. Following the 510(k) path, the FDA will review company’s submission and determine whether or not a proposed device is substantially equivalent to a predicate device that is legally in the market. If the two devices are comparable in terms of intended use, technological aspects and safety & effectiveness, the device will be cleared for marketing.
CE (French: Conformité Européene) Marking System, European Union
European Union is the primary regulatory authority for 25 countries encompassing most of the major countries in Europe. The European Union requires manufacturers of medical products to obtain the CE mark for their products before selling them in the European Economic Area.
CE mark is a mandatory conformity symbol to indicate the compliance of the products with European medical device directives. Under the CE Marking system, AWAK Technologies will declare conformity with all essential requirements of the Directives and apply full quality assessment to obtain the CE mark for marketing approval.
Regulatory approvals for medical devices are also required in other markets. For instance, in Singapore, the Health Science Authority is the administrative body that controls the regulations of medical devices. AWAK Technologies will comply with all polices and regulations required by various authorities before entering the markets.