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2020年7月12日

Requirements for medical device license in Japan

Hi, this is Seika from support Gyoseishosi Law Firm.

Thank you for watching this seminar video.

Today I would like to introduce how to get medical device license in Japan. Also I will tell you detail

requirements and approximate time and costs.

1.Category of medical devices

All medical devices are categorized based on risk for human bodies.

Class1:General medical devices

Lowest lisk for human bodies such as eye glasses, surgical knifves, bandaid.

Class2: Controlled medical device

Relatively low risk for human bodies such as massage machines, MRI, Thermometer

Class3: specially-controlled medical device

Relatively high risk for human bodies such as contact lenses, implant

Class4 : specially-controlled medical device

invasive device and the highest risk for human body such as Heart pacemakers, stent.

Depends on this category, necessary licenses are different.

2. Necessary lincenses

If you plan to

①Market your products and manufacture medical devides by your self including storage and packageing, you need both marketing license and manufacturing license

②Market your products by your self but outsource all manufacturing process including storage and packageng, you need marketing license only.

③Just manufacturing medical devices, and ask other company to market your products, you need manufacturing license only.

Please note that this marketing license is different from selling license, so with this license you cannot sell medical devices to final uses such us clinics or individuals.

Also, manufacturing license is necessry for each place. So if you have several places for main assembly or storage, you need to get several manufacturing licenses.

3. Requirements for marketing license

The most diffficult thing for foreign companies is that hiring responsible people.

Basically they need to be ful time workers.

①You need three posisions to meet requirements

・Marketing Directors

Employ a person graduated from university and majord in science such as physics, chemistry, biology, engineering, information science, metallurgy, electricity, mechanics, pharmacology, medicine, or dentistry.

Or emply a person who has three years experience of engaging in quality control or post-marketing safety control of medicine or medical device .

And graduated from technical high school and learn physics, chemistry, biology, engineering, information science, metallurgy, electricity, mechanics, pharmacology, medicine, or dentistry

Foreign university is OK, but we need to ask government individually and prepare documents if the person meet requirements.

・Quality assurance manager

Three years experience of quality control or manufacturing control of medicine or meidcal devices. Or experience of quality control in factory which has ISO 9001 or ISO 13485.

Experience in other company is addmitted.

・Safety control manager

If you want to sell specially-controlled medical devices, three years experience of safety control is required. But for other medical devices, anyone can be Safety control manager.

②Renting a real office

You need to rent a real office and get your own space.

Vertual office is not allowed.

Before getting manufacturing license, local government visit your office and check the place.

③Preparing QMS manuals and GVP manuals

You need to prepare Quality Management System called QMS and comply with Good Vigilance Practice called GVP to meet requirements.

When local government visits your office, they also check if you have QMS manuals and GVP manuals and responsible people understand them well.

4. Requirements for manufacturing license

①Hiring a technical manager

Same requirements for Marketing Directors.

②Renting a real office

You need to rent a real office and get your own space.

And need to prepare adequate storage space.

Vertual office is not allowed.

Before getting manufacturing license, local government visit your office and check your facility.

5. Flow of getting licenses

Hiring people and making documents

Appply to local government with registration fees.

On-site survey

Getting licenses

After getting marketing license, plese make sure that you have to register your medical device one by one.

6. Time and Cost

It depens local govertment, but usually it takes 2months to get license after applcation.

Preparation time would be 1 or 2 months additionally.

The license is valid for 5 years. Every 5 years, reneal is required.

To sum up, obtainig necessary licenses are quite hard for foreign companies, so I will explain alternative way in next time.