90/385/EEC (AIMD)

International Laws and Regulations

Active implantable medical device (AIMD) is any active medical device that is intended to be totally or partially introduced into the human body for diagnostic or therapeutic purposes. Directive 90/385/EEC regulates the market readiness and service parameters for AIMD. Before the product can reach the global markets, it is required to qualify a 90/385/EEC standard.

Directive 90/385/EEC specifies the manufacturers and importers must meet to apply the CE mark and it is subject to strict standard and definition of health and safety before free movement in European markets.

By choosing third-party registrar, you are choosing to partner a dedicated team of experts who are ensure that your operations are running at maximum efficiency, safety and quality.

Services

90/385/EEC certification process begins with a thorough evaluation from product design, manufacturing till launching to the market, as well as examine whether or not your quality management documentation fulfills the requirements of the standard. Our experts will provide extensive guidances and assistances along every stage, ensure the assessment of your quality system is carried out effectively & efficiently.

Benefits

As an accredited third-party registrar, we have the authority to award 90/385/EEC certification which is recognized globally. With the CE marking, you're able to get the primary evaluation of European Markets, it's like a ticket for entrance to get the back-up support by European Union member. (European Union Directive has required mandatory to all medical devices products introduced to EU Market.)

References

The medical devices are subject to the specific regulations of different countries before sale is permitted.

For those Medical Device Manufacturers outside of EU member states are also required to find and assign one of European Union's representatives, who must be in the member state under the legal register, and be able to execute concerning duties of the marketing while keeping the connection with European Union competent authority.

We carry out the audit in accordance to 90/385/EEU (AIMD) directives in each production process and related documentation of quality management.

We can provide a medical devices audit under China (CFDA & CCC), USA (FDA 510(k)), Ministry of Health, Labour and Welfare, Japan (MHLW), Korea (KFDA) and other countries' regulations.

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