How to enter medical products into the European market?

European medical device spending power is very strong. Even in the past few years, the economic development in Europe has been relatively stagnant. However, in all aspects, Europe is still the second largest medical device market in the world after the United States. At present, the sum of medical device sales in all emerging industrial countries does not match Europe. Moreover, with the exception of a few countries such as Albania and Bulgaria, most European countries have a relatively good industrial base. The medical device industry is very developed, and the level of medical care and hospital equipment are also high.

According to foreign media reports, in 2010, the global medical device market had total sales of approximately 184.9 billion euros, of which Europe accounted for approximately 30% (55.3 billion euros). The medical device markets of Germany, France, the United Kingdom, Italy and Switzerland accounted for about 76% of the European medical device market, while other European countries accounted for less than a quarter of the market. This shows that the European medical device market is highly centralized and there are huge differences in economic development. At present, many companies want to enter the European market because once they have established a foothold in the European market, their profits will be higher than those obtained in other continents.

About market access The EU has issued three directives relating to medical device products in order to harmonize medical device management standards in various European countries in accordance with the classification criteria for medical device products. The three instructions are: 1. Active Implantable Medical Devices Directive (ATMD, 90/335/EEC); 2. Medical Device Directive (MDD 93/42/EEC); 3. In Vitro Diagnostic Device Directive (IVD 98/79EEC). Among them, the second directive has the widest scope of application. It covers almost all medical device export products in China, such as medical dressings, medical catheters, disposable syringes, infusion pumps, medical gloves, anesthesia machines, ventilators, and endoscopes. , patient monitors and so on.

Manufacturers who want to enter products into the European market need to carry out production line modifications in accordance with ISO 13460 and other quality management regulations. The EU will send staff from time to time to inspect whether these production companies strictly comply with EU requirements for production and management. The EU implements stricter EN 46001 for the quality assurance system of medical device products (the implementation rules and regulations in the MDD appendix issued by the EU). Only in full compliance with the above provisions, manufacturers can obtain CE certification, that is to obtain the qualification of exporting medical device products to the EU market.

The EU access threshold for medical devices, or CE certification, is equivalent to the FDA's 510(K) regulations. Under normal circumstances, the access speed of the EU medical device market is faster than that of the United States. However, officials of the American Medical Device Industry Association once stated that even if the product has been CE-certified by the European Union, there is no guarantee that it will soon gain a foothold in the European market because it involves many difficulties, such as the establishment of hospitals and other medical device users trust Degree and so on.

Then, after the medical device products obtained the European Union CE certification, how can we successfully occupy the market? In the United States, Cleveland (one of the two major cities in the United States medical device industry, and the other is Boston), Mr. Paz, president of the Medical Device Industry Association, said that there are four measures worth trying.

To obtain the trust of a well-known hospital, make friends with doctors and related personnel who are in charge of medical devices in the famous European hospitals, and let them know about your products. Because only the first major European hospitals are taken away and doctors in large hospitals trust your products, European small and medium hospitals will gradually trust and purchase your products.

It is also a good idea to find a reliable general agent to find product agents in European countries. If you are unfamiliar in Europe, it is difficult to contact the head of the purchasing department of the local medical department. And your company is small and economically strong. Of course you can't compete with big companies like Siemens, IBM, GE and Shimadzu, Toshiba. Then, the shortest way for your product to enter the European market is to rely on reliable local agents. These agents must have a solid foundation of cooperation with the heads of the procurement departments of local hospitals. "If you can find a reliable European agent, it means that your product has entered the European market," Paz said.

It is important to keep in mind that high value products do clinical trials first – if your medical device products are expensive, then it is best to develop your products first in major European countries such as Germany, France, the United Kingdom, Italy, and Switzerland. test. This is because European doctors generally believe that the medical level in Europe is the highest in the world. Most of them do not trust the results of clinical trials in foreign hospitals, especially in developing countries such as China, India and Brazil. Therefore, if you only hold a product clinical trial report from your home hospital, it is likely that you will not be valued by European hospitals. In order for your high-priced products to enter the European market smoothly, you must spend a lot of money to conduct clinical trials in famous European hospitals.

Some members of the American Medical Device Industry Association stated that "this investment is very worthwhile, because once your product can be listed in Europe, then the economic return is considerable."

If you have a product with a relatively low economic value, such as a medical dressing, or a disposable product such as a disposable syringe, or a product with a low technical content such as an operating table or wheelchair, you may wish to Products are sold directly to European distributors. They are often very happy to sell for foreign companies in order to share some of the profits - this is a win-win situation for both parties.