• ①Are beauty devices and health equipment medical devices? Do I need permission?
• ②Do I need permission even if I want to import and sell medical devices that are already sold in other countries?
• ③I will temporarily store the product at the manufacturer's distribution center.Do I need permission?
• ④I have heard that ``If you call it a health appliance, you don't need to go through any procedures to treat it as a medical device.'' Is that true?
• ⑤There are classifications of medical device manufacturing and sales businesses from Class I to Class III. If I manufacture and sell medical devices of multiple classes, do I have to obtain permission for each class?
• ⑥I heard that colored contact lenses are miscellaneous goods, but have they become medical devices?
• ⑦Is the inclusion of package inserts considered a manufacturing act?
• ⑧What is the point of renewing the permit?
• ⑨What type of application is required when changing equipment or manufacturing processes?
• ⑩Is it okay for the company president to be the general manufacturing and sales manager?
• ⑪Is there a scope in which the general manufacturing and sales manager can concurrently serve?
• ⑫Could you please introduce or arrange for someone who meets the requirements for a general manufacturing and sales manager position?
• ⑬We import medical devices manufactured at overseas manufacturing facilities into Japan. Does the examination body go overseas for inspections?
• ⑭I have made a model change to my product, do I need to submit a notification?
• ⑮There is a template for the QMS/GVP manual, but is it okay to use it?
• ⑯What is the difference between ISO13485 and QMS ministerial ordinance?
• ⑰In addition to medical equipment, we also handle other products. Can I store them in the same place?
• ⑱We have both manufacturing and sales licenses. There are some duplicate books such as inventory/output history, can I unify them into one?
• ⑲If I only purchase products from a manufacturer and sell them, is it okay to apply for permission and notification only at the head office?
• ⑳How long is the license for sales and rental of highly controlled medical equipment etc. valid?
• ㉑Can I request storage management of my company's medical devices at another company's warehouse?
• ㉒Do I need a sales license to exhibit at a showroom or exhibition?
• ㉓I own a medical equipment repair business, but to what extent do you mean repairs?
• 22What should I include in the "item summary" that should be included in the documents attached to the manufacturing and sales certification application?
• ㉕In what cases is succession of manufacturing and sales approval for medical devices allowed?
• ㉖I heard that the department in charge of pharmaceutical affairs holds a seminar, but what kind of seminar is it?
• 23.Please tell me about insurance coverage for medical devices.
• ㉘I heard about a drug supervisor certificate, but what is it?

①Are beauty devices and health equipment medical devices? Do I need permission?

Even if something is called a beauty device or a health device, if it actually falls under the definition of a medical device, it is considered a medical device.
If it is a medical device, you will need a manufacturing and sales license, a manufacturing license, and product approval, certification, and notification.

②Do I need permission even if I want to import and sell medical devices that are already sold in other countries?

Even if medical devices are sold in other countries, it is unclear whether they comply with Japanese standards, so in order to import and sell them in Japan, new approval procedures are required in Japan.

③I will temporarily store the product at the manufacturer's distribution center.Do I need permission?

The distribution center of a manufacturer that ships medical devices is an independent business office and requires a sales license.
If the product is in the distribution process after a shipping request has been made to a carrier, a business license is not required.

4I have heard that ``If a product is labeled as a health device, it does not require any formalities to be considered a medical device.'' Is this true?

The name does not matter as long as the use of the device produces the effects and efficacy defined by the medical device. permission required

⑤There are classifications of medical device manufacturing and sales businesses from Class I to Class III. If I manufacture and sell medical devices of multiple classes, do I have to obtain permission for each class?

If you have permission from a higher level, there is no need to obtain permission from a lower level.

⑥I heard that colored contact lenses are miscellaneous goods, but have they become medical devices?

Previously, color contact lenses were treated as miscellaneous goods if they were non-prescription colored lenses. However, due to numerous reports of health hazards, color contact lenses now require the same "highly-regulated medical device sales business" license as regular contact lenses in order to be sold.

In addition, when selling contact lenses, the following guidelines are in place: ``confirmation that the patient has been examined by a medical institution,'' ``providing information on health hazards and encouraging the patient to see a medical institution if he or she has not visited a medical institution,'' and ``proper use.'' "When you receive information about health hazards, make efforts to provide information such as the nature of the health hazards to the medical institution you visited before purchasing." The Ministry of Health, Labor and Welfare has notified us that it is necessary to comply with laws and regulations regarding health and hygiene.

⑦Is the inclusion of package inserts considered a manufacturing act?

This is a manufacturing activity. In this case, since it is part of packaging, manufacturing registration is required at the place where the work is carried out.

⑧What is the point of renewing the permit?

For both marketing and marketing businesses and manufacturing businesses, the implementation status of the standards stipulated at the time of new application and the revision of the Pharmaceutical Affairs Law will be updated. Check to see if it has been done.

⑨What type of application is required when changing equipment or manufacturing processes?

This is a change application. The application must be submitted with a FD along with the "List of planned manufacturing items and documents related to the manufacturing process related to the change" and a "Summary of the structure and equipment of the manufacturing facility related to the category of the permission to be changed."

⑩Is it okay for the company president to become the general manufacturing and sales manager?

The person responsible for implementing the requirements of the manufacturing and sales business is the General Manufacturing and Sales Manager. If the president were to become the General Manufacturing and Sales Manager, the influence of business perspectives such as profitability would become stronger, and there is a possibility that internal management would not go well.

⑪Is there a scope in which the general manufacturing and sales manager can concurrently serve?

Depending on the type of manufacturing/sales license and the position, a person may serve as a manager, supervisor, or domestic quality management manager. As long as it does not interfere with the performance of each position, a person may hold two or more positions.

⑫Could you please introduce or arrange for someone who meets the requirements for a general manufacturing and sales manager position?

We do not provide job placement or recruitment services. Please use Hello Work (public employment service) or other recruitment agencies to find employment.

⑬We import medical devices manufactured at overseas manufacturing facilities into Japan. Does the examination body go overseas for inspections?

In principle, the investigation for certification of foreign manufacturers is a written investigation. However, an on-site investigation may be conducted if the organization deems it necessary. In the case of an on-site investigation, the investigation fee is different, and the applicant must also cover the travel expenses of the investigator. The "applicant" is the foreign manufacturer.

⑭I have made a model change to my product, do I need to submit a notification?

In the case of a complete model change, it is necessary to apply for new approval or certification as a separate item.

⑮There is a template for the QMS/GVP manual, but is it okay to use it?

What is in the template are the minimum requirements. After meeting these requirements, it is necessary to adjust the content to suit the actual situation.

⑯What is the difference between ISO13485 and QMS ministerial ordinance?

ISO13485 is an international standard for quality assurance of medical devices. QMS Ministerial Ordinance is a quality management standard for medical devices under Japanese law (Pharmaceutical and Medical Device Act). Since ISO is an international standard, obtaining ISO13485 may be a condition when exporting products overseas.

⑰In addition to medical equipment, we also handle other products. Can I store them in the same place?

There is no problem if the storage location is a warehouse, but medical devices and other products must be stored separately in the warehouse.

⑱We have both manufacturing and sales licenses. There are some duplicate books such as inventory/output history, can I unify them into one?

Manufacturing and sales business and sales business are different businesses. Basically, accounts must be created separately.

⑲If I purchase from a manufacturer and only sell it, is it okay to apply for permission and notification only at the head office?

For highly-managed medical devices and special maintenance-managed medical devices, a license is required for each business establishment that handles them. For controlled medical devices, a notification is required for each business establishment that handles them. For general medical devices, neither a license nor a notification is required.

⑳How long is the license for sales and rental of highly controlled medical equipment etc. valid?

It's been 6 years. Renewal procedures are required to continue the permit.

㉑Can I request storage management of my company's medical devices at another company's warehouse?

Warehouse operators that do not have permission (notification) to sell or rent goods are not permitted to manage such goods. They must obtain permission (notification).

㉒Do I need a sales license to exhibit at a showroom or exhibition?

Since the showroom is a business office, a sales permit is required even if there is no sales on the spot. A permit is required if the exhibition has a purpose such as a sales business, but if it is simply a display or exhibition and is managed by the manager of the office nearest to the venue, a permit is not required.

㉓I own a medical equipment repair business, but to what extent do you mean repairs?

The repair of medical equipment means restoring parts that are broken, damaged, or deteriorated to their original condition and function. Repairs include inspections and replacement of deteriorated parts as necessary, but do not include maintenance inspections such as cleaning and replacement of consumables.

㉔What should I include in the "item summary" that should be included in the documents attached to the application for manufacturing and sales certification?

1. Item overview
2. Compliance with certification standards, etc.
3. Comparison with similar medical devices
4. Usage status in foreign countries

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㉕In what cases is succession of manufacturing and sales approval for medical devices allowed?

The cases in which the succession of medical devices is permitted are as follows: 1. When an approval holder undergoes inheritance or merger. 2. When an approval holder transfers all materials and information on the quality, efficacy and safety of the pharmaceutical products, etc. to be succeeded for the purpose of succession of its status by contract with a successor.

Details

㉖I heard that the department in charge of pharmaceutical affairs holds a seminar, but what kind of seminar is it?

Each prefecture holds seminars on the latest trends in pharmaceutical administration. Information is available on the websites of the relevant departments. It is recommended that you attend these seminars after obtaining permission, as you may be able to speak to the relevant officials.

㉗Please tell me about insurance coverage for medical devices.

In order to use approved or certified medical devices of class II or higher in insurance treatment, they must be covered by insurance.
The material price, which is the insurance reimbursement price for medical devices, is divided into the following two types.
1. Items that are included in technical fees and cannot be redeemed separately
⇒Medical equipment commonly used in hospitals, such as MRI, CT, ultrasonic surgical instruments, scalpels, and syringes
2. Separate from the procedure fee, "Specified Health and Medical Materials" have individual material prices set and reimbursed for each function of the medical device.
⇒Single-use pacemakers and catheters, orthopedic materials, and dental materials consumed at hospitals for each treatment or examination

After the manufacturer and distributor obtains approval (certification), they must submit an application for insurance coverage to the Economic Affairs Division of the Medical Policy Bureau according to the classification.

㉘I heard about a drug supervisor certificate, but what is it?

A medical inspection certificate is a certificate required at customs when importing medical devices that have not yet been approved or certified in Japan. However, they cannot be imported for business purposes (selling or giving to others). A medical inspection certificate is obtained by applying to the relevant health and welfare bureau.