Medical Device Directive and DIMDI Registration in China

Medical Device Directive

Compliance with the Medical Device Directive for products from China

All medical devices placed on the market in Germany are subject to the Medical Devices Directive – whose somewhat unwieldy actual name is “Directive 93/42/EEC concerning medical devices”. It sets out the requirements for the safety and marketability of medical devices.

It is not possible to import medical devices into Germany without complying with the conditions of the Medical Device Directive.

Not all medical devices from China are covered by the directive. By definition, it covers products that serve the following purposes:

• Detection, prevention, monitoring, treatment or alleviation of disease.
• Detection, monitoring, treatment, mitigation, or compensation of injury or disability.
• Examination, replacement or alteration of the anatomical structure or of a physiological process.
• Contraception

There are a number of exceptions, for medical devices from China or other countries. The following items are not within the scope of the Medical Directive:

• active implantable medical devices (e.g. pacemakers) are subject to Directive 90/385/EEC
• In vitro diagnostic medical devices are subject to Directive 98/79/EC
• solid non-reusable units with a drug (drug kit)
• Other national exceptions

Agentur Frisch can provide you with expert advice on this subject. We can tell you whether the product you imported from China for the German market falls under the scope of the Medical Directive or any other national directive.

Production of medical devices from China

If your imported product is covered by the Medical Directive, you must comply with special regulations. Depending on the risk class, there may be different actions you need to take. There are four classes in the production of medical devices in China according to the Medical Device Directive:

• Class I, low risk
• B. Reading glasses, wheelchairs, clinical thermometers

• Class IIa, medium risk
• B. Dental fillings, hearing aids, ultrasound equipment

• Class IIb, high risk
• B. Condoms, infusion pumps, contact lenses

• Class III, high risk
• B. Cardiac catheters, hip implants, breast implants

For Class I medical devices, the relevant technical documentation is sufficient for approval. Products in Class II and above must be inspected by a notified body. We can help you to comply with the Medical Device Directive for products from China by preparing the documents already in the course of the production of the medical devices in China, or by performing all the steps necessary for the preparation of the independent verification of your medical devices from China.

DIMDI registration and general medical guideline compliance for products from China

For some steps in the compliance with the Medical Device Directive for products from China, the action of a “qualified person” is required. The requirements for these are clearly defined by the directive. Agentur Frisch will be happy to find you a qualified, liable person who is also responsible for the DIMDI registration.

Importing responsibly – medical devices from China

We recommend that you do not take the issue of compliance with the Medical Device Directive lightly when dealing with products from China. Even during the production of medical devices in China, it is necessary to ensure the highest standards and to fulfill all conditions with regard to the Medical Device Directive.

As an experienced China import service provider, we offer you all the service you need in connection with compliance with the Medical Device Directive 93/42/EEC. We work exclusively with trustworthy producers in China, and carry out inspections and documentation with the utmost conscientiousness.

Importing medical devices from China is a matter of trust. Rely on us as your experienced, reputable China importer.