■What's "Restrictive Approval of Medical Equipments Manufactured in Foreign Countries"?

Establish Japan office and take Marketing Authorization Application is thought of as an idea, if foreign medical-equipment company wants to export and sell their products in Japan. But it needs huge costs, furthermore it is high risky way without having adequate experiences and know ledges in Japanese market.Furthermore it is possible that you offer Japanese medical equipment company to take Marketing Authorization Application. But it is possible that you will be controlled product expansion in the market. Now, I would like to suggest you to use a system; "Restrictive Approval of Medical Equipments Manufactured in Foreign Countries". his system is established by the pharmaceutical affairs law. Japanese Marketing Approval Holder who was picked out by foreign medical-equipment company apply manufacturing approval for exporting medical equipment to Japan, and sell imported such equipments in Japan, instead of them. Thus any foreign medical-equipment company, who doesn’t have branch in Japan, is able to directly obtain manufacturing approval in Japan.

The pharmaceutical affairs law article 19-2.1 says;

On this occasion, Such foreign medical-equipment companies who want to apply for "Restrictive Approval of Medical Equipments Manufactured in Foreign Countries" must follow as below.

The Pharmaceutical Affairs Law Article 19-2, Article 19-3, Article 19-4 and Article 20 are concerned to "Marketing Approvals of Drugs Manufactured in Foreign Countries."

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■What are The Differences Between Before and After Revision of the Pharmaceutical Affairs Law?

Before revision, In-County Caretaker (ICC), who applies "Manufacturing Approval" and importer of medical equipment, could be other person. But after a revision of the pharmaceutical affairs law on April 2005, ICC and Marketing Approval Holder (MAH) must to be same person. In fact, MAH should conduct it as both ICC and importer, after that. Furthermore, on the previous pharmaceutical affairs law, ICC did not need any license. On the other hand, MAH must have manufacturing approval of medical-equipments on the new regulations of the pharmaceutical affairs law. ICST has been already approved "No.2 type license for marketing business of medical device" on the revised new law. (Approved license#: 11B2X10002) It shows ICST surely has credentials to be a Marketing Approval Holder (MAH) for No.2 type of medical device.

Here are lists of categories what ICST can handle in Japanese market.
(Sorry, Japanese language only now.)

1. Level 1 category (General Medical Equipment)
2. Level 2 category (Managed Medical Care Equipment)

For your information:
List for all level medical equipments (incl. categories which ICST can’t handle)

■Get a Chance with Using the System "Restrictive Approval of Medical Equipments Manufactured in Foreign Countries"

Many foreign medical companies had overlooked a chance in Japan, because of a lack of understanding these systems. There are three big merits of the System "Restrictive Approval of Medical Equipments Manufactured in Foreign Countries."

• Able to get a manufacturing license directly.
• More chance to expand sales channels.
• Cost reduction.

By directly controlling manufacturing license by yourself, you can control timing for product rollout easier than a situation with ordering selling agents.Thus Foreign Medical Equipments Manufactures are able to get more chance to expand sales channels, without any binding of agent family problems. And a foreign company can reduce much cost than establishing branch in Japan. Also if a foreign company could select a good Marketing Approval Holder who is an expert at the Pharmaceutical Affairs Law, the company may able to take out "Manufacturing Approval in Japan" smoothly. MAH can fully support a foreign company’s applying "Manufacturing Approval" in Japan, that’s why foreign companies, who know very little about The Pharmaceutical Affairs Law, can export and get into Japan market without bothered.

1. Translation original MDD and FDA text, Preparation of documents for applying "Manufacturing Approval" of foreign-made medical-equipments.
2. Updating and Management documents after approved "Manufacturing Approval"
3. Open the window for "Health, Labor and Welfare Ministry", other foreign medical-equipment manufacturer, complaint in Japan, and so on.

If you are interested in exporting medical-equipments to Japan market, Please don't hesitate to contact us anytime! We'll be happy to answer your every question!