Japan is a rich market for medical devices, with the country's ageing population in particular leading to an ever-increasing demand for sophisticated medical care.
While foreign companies seek to expand to export their goods to Japan, many are knocked back by the many registration and authorization procedures. With regulations only getting stricter, it is highly risky to embark on any of these applications without professional guidance - especially the more advanced ones, which can take years to fully process.
At Support Gyoseishoshi Law Firm, we know the ins and outs of the laws surrounding the medical devices industry.
What follows is a basic introduction to the kinds of procedures you will face as a non-Japanese corporation engaging in the manufacturer and trade of medical devices.
For advice tailored to you and your company, contact us today for a free consultation session!
Basic Guide to Permits & Accreditation Procedures
The following shows which permit/accreditation is necessary according to the type of business activity you wish to carry out in Japan.
|Export goods manufactured overseas to Japan||Accreditation as Foreign Manufacturer||・Must be renewed every 5 years|
|Shipping goods made by another company to Japan||Manufacturing and Sale Permit*||・Manufacturer is directly responsible for shipping of goods|
|Shipping goods made by your own company to Japan||Manufacturing and Sale Permit*|
|Manufacturing Permit||・Manufacturer is not directly responsible for shipping of goods
・Does not include permit for shipping
|Manufacturing within Japan||Manufacturing Permit|
|Selling and loaning medical devices in Japan||Sale and Loan Permit||・Procedures vary between different classes of devices, with no permit necessary for Class 1|
|Repairing medical devices in Japan||Repair Permit||-|
Accreditation as a Foreign Manufacturer
In order to import or export goods to Japan which were manufactured overseas, you must first be accredited as a foreign manufacturer. Japan’s regulatory body for medical devices, the PMDA (Pharmaceuticals and Medical Devices Agency), provides a detailed explanation of this procedure in English, a short summary of which we provide below.
※Please note that there may have been changes to the following information since its publication for which we cannot take responsibility. Please contact us for more information or refer to the most recent information available from the PMDA.
What is the accreditation for?
The accreditation process is designed to ensure that foreign manufacturers meet the same requirements as Japanese manufacturers. At the end of the process, foreign manufacturers will be recognized as Accredited Foreign Manufacturers as specified in Article 13-3 of Japan’s Pharmaceutical Affairs Law (PAL).
How long does it take?
There is no set period for the application process. However, it is generally estimated to take approximately 5 months.
Can I apply for multiple types of accreditation in one go?
No. Accreditation applications for different categories must be submitted separately.
What kind of documents do I need to submit?
The basic documents are as follows:
① A medical certificate stating that the applicant is not suffering from any mental disorders or addictions to narcotics, cannabis, opiates or stimulants.
※If the applicant is a corporation, a signed written statement that the relevant executives are not adult wards and do not fall under item 3 (d) and (e) of Article 5 of PAL can be submitted instead.
② A CV/resume of the person who is responsible to the manufacturing establishment.
③ A list of products to be manufactured for export to Japan and documents detailing the manufacturing process.
④ Documentation relating to buildings and facilities of the manufacturing establishment
⑤ Documentation relating to radiopharmaceuticals and the outline of facilities for handling such radiopharmaceuticals (excluding cases in which the amount of radiopharmaceuticals is equal to or less than the limit designated by the Health, Labor and Welfare Minister).
⑥ A valid license certificate issued by the country in which the drugs and/or medical are manufacturer (when the country in question has an established system for marketing licensing, manufacturing licensing, marketing approval, marketing certification of drugs and medical devices or some other equivalent system).
Japanese translations are necessary for all of the above.
Does the accreditation need to be renewed?
Yes, every 5 years.
Do I need to notify the Ministry for Health, Labour and Welfare of any changes following accreditation?
Yes. Changes such as the following should be declared within 30 days of occurrence.
・The name or address of the person responsible for the manufacturing establishment.
・Name of the executives responsible for the services (when the manufacturer is a corporation).
・Name of the manufacturing establishment.
・Major part of buildings and facilities of the manufacturing establishment.
・Category and (deemed) accreditation number, when a foreign manufacturer obtains additional accreditations for another category, or discontinues operation of their accredited manufacturing establishment.
Medical Devices Industry Permit Requirements
Below is an outline of the requirements for the various permits available in the medical devices industry.
N.B. These are general requirements and do not necessarily reflect the reality of what may be needed for your specific application.
Manufacturing and Sale Permit
Manufacturing and Sale Permits require employment and placement of the following individuals:
① Sales and Manufacture Manager
② Shift Supervisor
③ Chief Administrator
④ Quality Assurance Manager of Goods in Japan
⑤ Safety Manager
Please contact us for up to date information on the necessary qualifications for each of these individuals.
The main requirement for manufacturing permits is the employment and placement of a technical supervisor. Depending on the type of medical devices you are handling, the requirements for this individual will be different. Please contact us for more information.
Sale and Loan Permit
Gaining permission for the sale and loan of medical devices requires the following:
① A workplace with adequate lighting, ventilation and standards of hygiene, separated from any living spaces, unhygienic areas and providing the appropriate space for the hygienic handling of medical devices.
② The employment and placement of an appropriately qualified* Workplace Manager.
*Qualifications vary depending on the type of medical devices being handled. Please contact us for up to date information.
In order to acquire a repair permit, your facilities must:
① Allow you to carry out the safe and hygienic repair of medical devices and/or their component parts.
② Enable you to carry out necessary tests on medical devices and/or their component parts.
③ Meet standards for lighting, plumbing, ventilation, hygiene, damp proofing and more.
Meeting the above criteria is not as simple as a tick-box exercise, with specific requirements varying between prefectures as well as the type of repairs you are carrying out. Please contact us to find out more about your specific case.
・Having had a permit revoked in the past 3 years under Article 75 Paragraph 1 of the Pharmaceutical Affairs Law.
・Having had a permit revoked in the past 3 years under Article 75(2) Paragraph 1 of the Pharmaceutical Affairs Law.
・Having finished a period of imprisonment or other more serious punishment within the last 3 years.
・Having committed any other unlawful acts within the last 2 years involving narcotics, psychotropic drugs, poisons or other dangerous medical goods.
・Being an adult ward.
・Being addicted to narcotics, cannabis, opium or psychoactive drugs.
・Being judged psychologically unfit by the Ministry of Health, Labor and Welfare standards to carry out business to the necessary standard.
Classification of Medical Devices
Medical devices are broken down into 4 classes, as shown below.
|1||General medical devices||Devices which present minimal medical risk when damaged
・E.g. extracorporeal diagnostic devices, technical dentistry equipment, band aids, tweezers
|2||Controlled medical devices||Devices which present relatively low risk when damaged
・E.g. MRI scanners, electrical blood pressure gauges, home massage chairs
|3||Specially controlled medical devices||Devices which present relatively high risk when damaged
・E.g. artificial bones, dialysis machines, contact lenses
|4||Devices which are highly invasive and risk danger to human life when damaged
・E.g. pacemakers, artificial heart valves, stent implants
For any further queries about Japan’s medical devices industry or about how to establish your medical devices business, please do not hesitate to contact us!
*Please be aware that the contents of this site are naturally subject to change, meaning that we cannot guarantee their accuracy at the point of access.
For up-to-date information, please contact us directly.*