Building a QMS system

Updated: July 2024, 9

At Support Administrative Scrivener Corporation, one of our specialized fields is application for permits and licenses related to medical devices and operational support for business operators.

We are not just experts in creating documents. We are experts in helping businesses starting new businesses smoothly, and businesses that have already received permission to operate businesses based on legal compliance.

For medical device business operators, we will introduce the QMS construction menu along with examples that we have been in charge of implementation.

From GQP to QMS

With the enforcement of the "Act on Ensuring the Quality, Efficacy, and Safety of Pharmaceuticals and Medical Devices, etc." (abbreviation: Pharmaceutical and Medical Devices Act), the former Pharmaceutical Affairs Act required manufacturers and distributors to maintain quality control systems based on the GQP ministerial ordinance. Currently, a quality control system based on the "Ministerial Ordinance on Manufacturing Control and Quality Control Standards for Medical Devices and In-Vitro Diagnostic Reagents" (abbreviation: QMS Ministerial Ordinance) is required.

Standards based on the GQP Ministerial Ordinance have been removed.

QMS system required in the manufacturing and sales industry

Prior to the enforcement of the Pharmaceuticals and Medical Devices Act, when applying for a license for a manufacturing and sales business, GQP procedure manuals and record forms were created, and permission was granted after being reviewed by the prefecture, but the Pharmaceuticals and Medical Devices Act After enforcement, permission will be granted after establishing a system based on the QMS Ministerial Ordinance.

However, building a QMS (Quality Management System) has many aspects related to the medical devices being handled, and it can be difficult to build a complete QMS, especially at the stage of applying for a new license.

Therefore, when prefectures conduct licensing examinations, the Ministry of Health, Labor and Welfare has issued the "Ministerial Ordinance Concerning Standards for Systems that Perform Work Related to Manufacturing Control or Quality Control of Medical Devices or In-Vitro Diagnostic Reagents" to ensure compliance. This is one of the requirements for permission.
This Ministerial Ordinance is called the "System Ordinance."

1 Standards related to organizational structure (related to Article 3, Paragraph 1 of the Ministerial Ordinance on Structure)

Manufacturers and distributors, who have the heaviest responsibility in distributing medical devices to the market, must establish a quality control supervision system, carry out documentation, and maintain the necessary organizational structure and quality control supervision documents. It is necessary to establish the organizational structure necessary to appropriately manage and store records, and the necessary organizational structure to appropriately manage and store records.

When applying for a permit, you will need to prepare a document certifying that you have a system that meets the requirements below and undergo an examination.

① Requirements related to quality control supervision system
② Requirements related to documentation of quality control supervision system
③ Requirements related to quality control supervision system standards
④ Requirements related to the management of quality control supervision documents
⑤ Requirements related to record management

2 Standards related to personnel assignment (related to Article 3, Paragraph 2 of the Ministerial Ordinance on System)

Medical device manufacturers and distributors are required to appoint a supervisor, general marketing and sales manager, etc. so that they can properly perform quality control operations based on the QMS ministerial ordinance.

When applying, you will need to submit a document that describes the career history, responsibilities, management system, etc. of the person in charge below, and it will be reviewed.

① Management supervisor
② Manager
③ General manufacturing and sales manager
④ Domestic quality operations manager

Response to QMS system ministerial ordinance for limited type 3 medical device manufacturers and distributors

A limited type 3 medical device manufacturer is a company that only manufactures and sells medical devices other than general medical devices designated by the Ministry of Health, Labor and Welfare as requiring careful manufacturing control and quality control (limited general medical devices). .

The following provisions of the QMS System Ministerial Ordinance do not apply to Limited Type 3 Medical Device Manufacturers:

For consultation regarding permits and licenses regarding medical devices, please contact Support Administrative Scrivener Corporation.

At the Support Administrative Scrivener Corporation, we provide application support and consulting regarding the Pharmaceutical and Medical Device Act for everyone, from those newly entering the medical device industry to existing marketing distributors, manufacturers, and distributors. .

Applications for medical devices are highly specialized and can be said to be one of the fields in which there are few administrative scriveners who can handle them.

Our staff has a track record of applying in all prefectures across the country. Please contact us by all means.

Our dedicated staff handles cases nationwide.