Increased requirements are imposed on such equipment during certification, because human life and health directly depend on its quality and safety. The rules apply to both domestic and foreign medical equipment. All medical equipment is subject to mandatory certification for compliance with State Standards. Without a document of devices (or in some cases, a declaration of conformity) medical equipment cannot be allowed to be sold and used. According to the Government Decree “Unified list of products subject to mandatory certification and Unified list of products, confirmation of conformity of which is carried out in the form of a declaration of conformity” the following medical equipment is subject to mandatory certification: medical devices and accessories, surgical instruments and related products. In addition, medical device companies may be required to make a declaration of conformity (MCC) and certification of compliance (COC) document and submit it to the local authority.
Similarly, the requirements for auditing medical devices are much stricter than the requirements for pharmaceuticals. The requirements for medical devices and accessories, surgical instruments and related products are regulated by the Rules for Auditing Medical Devices and Accessories and Auditing Medical Instruments. Under these regulations the auditor must report immediately to the local authority, when discrepancies are detected by the inspection. When the auditor observes problems with a medical device or accessories, according to the Rules for Auditing Medical Devices, the representative or inspectors of Australian must immediately contact the manufacturer, if there is a request. If the manufacturer decides to comply, they should report the manufacturer and the following information:
Description of the medical device or accessory
Recording date, production date and batch number of the medical device or accessory. Product name and manufacturing information (location of the manufacturing facility, name of the employee of the company and contact details)
Information about the person or entity that requested for the verification and (follow up of what was requested)
Information about the company providing an audit or inspecting the medical device or accessory.
The majority of the devices and accessories subject to mandatory certification are limited to local medical systems, such as hospitals, clinics and medical centers. However, the documentation of some devices, such as MRI systems, are submitted to Australian for worldwide certification. Even so, according to the Regulations (Regulation 2.1) every international medical device or accessory that is not certified by Australian or international medical certification agencies, or that does not comply with the Technical Standards for International Medical Devices (TS4-1) should be rejected by the supplier or importer. The documentation of international medical devices (such as MRI machines) is not submitted to Australian for certification.
The procedure for auditing medical devices and accessories is different from the procedure for pharmaceuticals. A license from the Australian Medicines and Health Products Agency (Medicines and Health Products Regulatory Agency) or a registration from the Australian Health Technology Assessment is not necessary for auditing the medical devices or accessories. As for pharmaceuticals, the Australian Government regulates the import and sale of medical devices and accessories.
To conclude, according to the Government Decree “Unified list of products subject to mandatory certification and Unified list of products, confirmation of conformity of which is carried out in the form of mandatory declarations and audits, subject to the approval of the local authority” there is a list of medical devices and accessories that must be certified and comply with the Australian regulations.
Benefits of conducting an audit of medical devices
An audit of medical devices by a medical device consulting company ensures the entire product life cycle is assessed by the same consultant.
This type of audit helps reduce the costs for medical device manufacturers. If a manufacturer does not comply with the requirements of regulations or medical regulations, it should be able to accept the consequences of a violation. Such an audit of medical devices and accessories enables the manufacturer to know exactly what is required to perform the manufacturing process of the medical device and apply the correct procedures.
A medical device consulting company, such as NeuroLogica, performs the process of auditing a medical device or accessory in a flexible way. In this way, an auditing of medical devices and accessories is not only a medical consultation service. It also includes a product compliance monitoring program that can be implemented in various phases of the product’s lifecycle, or as a recurring part of a medical device or accessory audit.
The process of an audit of medical devices includes following the following steps. The decision of doing an audit of medical devices depends on the requirements, the company, and the type of product.
Involve the manufacturer and verify the design of the medical device, not only the production.
If the manufacturer is under FDA, USDA, or CE registration, they should be able to submit the original design or the approved design for verification, and they are able to provide specific information on the process, manufacturer and where the product is manufactured.
Confirm the compliance of the medical device or accessory to regulatory requirements (medical devices must comply with FDA, USDA, or CE regulations).