Certification of controlled medical devices
Updated: July 2024, 9
In order to distribute a medical device domestically, it is necessary to receive medical device approval from the Pharmaceuticals and Medical Devices Agency (PMDA).
For some of the Class II and Class III medical device approvals, you will need to apply for "Medical Device Certification" and obtain a Medical Device Certification Number.
This medical device certification is not carried out by the Pharmaceuticals and Medical Devices Agency, but is entrusted to a certification body called a certification body, which handles everything from receiving applications, conducting reviews, QMS inspections, and issuing certification numbers.
At Support Administrative Scrivener Corporation, we support those who are considering distributing managed medical devices that fall under Class II to the market.
Flow of medical device certification
| Step 1 | Investigation of medical device suitability/application category | We will conduct an investigation to determine whether the medical device you are considering falls under Class II or Class III, and if so, whether it is subject to a "medical device certification application." |
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| Step 2 | Investigation of compliance with certification standards | For medical devices that are subject to an application for medical device certification, certification standards are shown that if they meet these standards, they can receive medical device certification. Certification standards are mainly JIS industrial standards, and it is necessary to verify whether each item is compliant. Verification methods include requesting compliance testing from an external testing organization, conducting the testing in-house, and checking whether overseas inspection reports comply with JIS industrial standards. |
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| Step 3 | Conducting conformance tests to JIS industrial standards | In cases where in-house testing is difficult or foreign test reports are not available in Japan, we request a domestic inspection agency to perform the test and conduct a JIS industrial standard compliance test. If each item is met, an inspection report will be issued. |
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| Step 4 | Medical device certification application form Application form creation | We will create an application form to apply for medical device certification. The application form can be broadly divided into two parts: a certification application form and an attached document called STED. STED includes inspection reports that comply with JIS industrial standards, so it is quite large. |
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| Step 5 | Medical device certification application submission | Apply to the certification body that issues the certificate. Application acceptance and screening methods differ depending on the certification body, so it is important to have a meeting in advance. |
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| Step 6 | QMS conformity survey | A QMS compliance survey will be conducted during the certification application review process. If this is your first case, the investigation will take a total of three days. Preparation should focus on design and development. |
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| Step 7 | Medical device certificate issued | A medical device certification number will be issued and you will be able to start manufacturing and selling medical devices. |
Application for medical device manufacturing and sales certification for controlled medical devices (class II)
For controlled medical devices for which certification standards have been set, manufacturers can apply for designated controlled medical device manufacturing and sales certification to a third-party certification body and receive certification, allowing them to be distributed domestically.
In addition, for medical devices, both overseas and domestic factories must have a management system in accordance with the QMS ministerial ordinance, so at the same time as applying for certification, an application for a QMS conformity survey is submitted and examined.
Documents to be submitted when applying for designated controlled medical device manufacturing and sales certification
| Manufacturing and sales certification application form | [Application form] Designated (advanced) controlled medical device manufacturing and sales certification application form: Form No. 64(1) Foreign Manufactured Designated (Highly) Controlled Medical Device Manufacturing and Sales Certification Application Form: Form No. 64(3) [Notice regarding creation] Matters to keep in mind when preparing an application for manufacturing and sales certification of medical devices (Yakushokuki Sanpatsu 1120 No. 4) Regarding application for manufacturing and sales certification of medical devices (Pharmaceutical Food and Drug Administration Department No. 1120 No. 8) |
| Attached document (draft) | [Notice regarding creation] Regarding the revision of the instructions for the package inserts of medical devices (Pharmacy and Food Safety Agency No. 1002 No. 8) Regarding the guidelines (details) for the package inserts of medical devices (Pharmaceuticals and Food Safety Bulletin No. 1002 No. 1) Q&A regarding instructions for filling out package inserts for medical devices (Administrative communication October 26, 10) |
| Materials related to compliance with the standards specified by the Minister of Health, Labor and Welfare as prescribed in Article 23-23-XNUMX, Paragraph XNUMX of the Act | [Material content] Documents explaining that the medical device involved in the application falls under the category of medical devices with certification standards. Materials explaining the purpose of use or effects of the medical device Documents showing conformity to the Japanese Industrial Standards or standards specified by the International Electrotechnical Commission cited in the certification standards Materials explaining that the device is not clearly different from existing medical devices [Notice regarding preparation of documents] Points to note when preparing documents to be attached to applications for certification of manufacture and sale of medical devices (Notification No. 0210-1 of the Director-General for Medical Devices and Pharmaceuticals and Food Safety) |
| If standards are established pursuant to the provisions of Article 41, Paragraph 42 of the Act or Article XNUMX, Paragraph XNUMX of the Act, materials regarding conformity to the standards. | [Material content] Materials regarding declaration of conformity to basic requirements standards Materials related to compliance with basic requirements standards Materials related to tests to prove compliance with basic requirements standards Materials explaining compliance with the standards pursuant to Article 42, Paragraph XNUMX of the Act [Notice regarding document creation] Matters to keep in mind when preparing documents attached to an application for manufacturing and sales certification of medical devices (Yakushokuki Sanpatsu 0210 No. 1) |
Documents to be submitted in QMS conformity survey application form
| Compatibility investigation application form | [Application form] Designated (highly) controlled medical devices, etc. Conformity investigation application form: Form No. 67(1) Foreign Manufactured Designated (Highly) Controlled Medical Devices, etc. Conformity Investigation Application Form: Form No. 67(2) |
| Attachment | [Material content] ① Copy of application form for manufacturing and sales approval, etc. of the applied item or application form for partial change approval, etc. of approval etc. ②ISO13485:2003 certificate, etc., on-site investigation report by another investigator conducted within the past XNUMX years from the date of application for conformity investigation at the facility to be investigated, certificate or investigation of the partner country based on MOU, etc. Copy of report, certificate of conformity issued by foreign authorities, etc. ③ Outline of the manufacturing process of the surveyed items ④ Materials that can confirm the outline of activities carried out at each survey target facility and the interrelationship of QMS at each survey target facility ⑤Other materials specified by the investigator as necessary [Notice regarding creation] Regarding the establishment of QMS investigation guidelines (Pharmaceuticals, Foods, and Foods Supervision Bulletin No. 1024 No. 10) Regarding the handling of standards conformity certificates and QMS conformity investigation applications (Yakushoku Kanpai No. 1119 No. 7/Yakushoku Kansai No. 1119 No. 3) Regarding selection of multiple product group classifications in QMS conformity investigation application (Pharmaceuticals, Foods and Drugs Administration Notice No. 1121 No. 21) Questions and Answers (Q&A) regarding standards for manufacturing control and quality control of medical devices and in vitro diagnostic drugs (Pharmaceuticals, Foods and Drugs Administration Bureau No. 1121 No. 25) |
Frequently asked questions
I want to sell measuring devices related to daily health management such as thermometers and blood pressure monitors.
Thermometers and blood pressure monitors are often considered as medical devices when companies from other industries enter the medical device industry. Measuring devices like this go through the necessary procedures to qualify as medical devices, but at the same time they must also clear regulations such as the Measurement Act.
I want to sell stylish home massage equipment.
Home massage machines are medical devices that fall under Class II. Recently, the size has been reduced from the conventional large ones, and even more stylish home massage machines have appeared.
I would like to develop and sell medical devices using magnets that are effective for stiff shoulders and promoting blood circulation.
There is a definition of home permanent magnet magnetic therapy device, and devices that use magnets to treat affected areas fall under this category. It is necessary to develop medical devices with medical devices in mind from the development stage.
For consultation regarding permits and licenses regarding medical devices, please contact Support Administrative Scrivener Corporation.
At Support Administrative Scrivener Corporation, we provide application support and consulting regarding the Pharmaceutical and Medical Device Act, 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.
We provide legal services related to medical devices based on the know-how and track record that we can accumulate because we are administrative scriveners who handle applications and negotiations with administrative agencies on behalf of companies on a daily basis.
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.
