Navigation of the regulatory process of the Japan PAL

Navigation of the regulatory process of the Japan PAL

BSI has identified the top 22 ordinances, notifications and memorandums which are fundamental to navigating the regulatory process of the Japan PAL.

●Ministerial Ordinances

MHLW Ministerial OrdinanceNo.135 (GVP)   (PDF size 44Kb)
Ministerial Ordinance on Standards for Safety Assurance for Drugs, Quasi-drugs, Cosmetics and Medical Devices after the marketing

MHLW Ministerial Ordinance No. 136, 2004 (GQP) (PDF size 74Kb)
Ministerial Ordinance on Standards for Quality Assurance for Drugs, Quasi-drugs, Cosmetics and Medical Devices. English translation is available

MHLW Ministerial Ordinance No. 169, 2004 (QMS) (PDF size 74Kb)
Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostic Reagents. English translation is available

MHW Ministerial Ordinance No. 2, 1961(PDF size 190Kb)
Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostic Reagents.English translation is available


●Ministry Notifications

【Specifically Designated Maintenance Medical Devices】

MHLW Notification No. 78 March 11, 2005 (PDF size 138Kb)
Revised list of the Specifically Designated Maintenance Medical Devices, as designated by MHLW

【Specially Controlled/Controlled/ General Medical Devices】

MHLW Notification No. 71March 10, 2005 (PDF size 163Kb)
List of the Specially Controlled Medical Devices, Controlled Medical Devices and General Medical Device as designated by MHLW

MHLW Notification No. 83 March 10, 2005 (PDF size 6Kb)
Partial amendment of Special Controlled Medical Devices

Notification by Yakushoku No. 0311005* (PDF size 55Kb)
andNotification by Yakushoku No. 0311005 Exhibit (PDF size 1Mb)

Partial amendment of Specially Controlled Medical Devices, Controlled Medical Devices, General Medical Devices and Specifically Designated Maintenance Medical Devices

【Specially Designated Installation Medical Devices 】


MHLW Notification No. 77 March 11, 2005 (PDF size 34Kb)
Revised List of Specially Designated Installation Medical Devices as designated by MHLW

【Control of Design and Development required Medical Devices】

MHLW Notification No. 84 Mach 18, 2005 (PDF size 94Kb)
List of Medical Devices designated by the Minister, based on the Ministerial Ordinance No. 169, Chapter 4, Article 1, which describes the standards of manufacturing and quality control for Medical Devices and IVD reagents (designation of the Medical Devices that need Control of Design and development)

【GMP required Class 1 Medical Devices】

MHLW Notification No. 85, March 18, 2005 (PDF size 55Kb)
List of General Medical Devices, as designated by MHLW, requiring manufacturing and quality control (QMS ordinance is applicable)
Designated Controlled Medical Devices

MHLW Notification No. 112, March 25, 2005 (PDF size 291Kb)
List of Designated Controlled Medical Devices designated by the Minister (Medical Devices subject to Product Certification by the Registered Certification Bodies.)
Designated Controlled Medical Devices

【Registered 3rd Party Certification Bodies】

MHLW Notification No. 252, June 7, 2005 (PDF size 29Kb)
List of the Registered Certification Bodies

MHLW Notification 391,September 2, 2005 (PDF size 10Kb)
ppointment of JAAME as Registered Certification Body ? JAAME (Japan Association for the Advancement of Medical Equipment)


●Notice by Bureau, Division and Offices at MHLW and Office Memorandum

【Registered Certification Segments】

Office Memorandum, September 15, 2004 (PDF size 76Kb)
Description of the registered segments of product certification that may be conducted by Registered Certification Bodies. This memo describes the 21 segments of Medical Devices and 1 segment of IVD regents. MAH (Maker Approval Holders) and Foreign manufacturers may choose a CB by referring to this memorandum.

Notice by Yakushokuki 0401001 April 1, 2005** (PDF size 2Mb)
List of all Class II Medical devices and provides information on the Japan Nomenclature, registered segments of certification, and applications of essential principle notification (i.e., whether the MD is Designated Controlled MD or not).

【Package Inserts】

Notice by Yakushokuan No. 0310001 March 10, 2005*** (PDF size 66Kb)
This notification is issued from Safety Division of Pharmaceutical and Food Safety Bureau of MHLW, especially the instructions for the description of safety. This includes the example of description for the Biological-origin Medical Devices.

Notice by Yakushoku No. 0310003, March 10 2005* (PDF size 41Kb)
Summarizes the matters indicated in Package Insert Notice, such as basic rules of device description, required contents listing, order and instructions. Package Insert is the document which describes the instruction manual, specifications etc.

【Application for certification related matters】

Notice by Yakushoku No. 0331032, March 31, 2005* (PDF size 181Kb)
Notification regarding the application of product certification for Medical Devices. It describes the conformity to Essential Requirement Standard and Certification Conformity Standard (JIS)

Notice by Yakushokuki No. 0331008, March 31, 2005**  (PDF size 1Mb)
An essential and necessary notification regarding cautions in order to describe the contents specifically in the application forms and attachments for the Medical Device product certification.

【Manufacturers】

Notice by Yakushokuki No. 0707001, July 7, 2005** (PDF size 386Kb)
Required attachments for the application of “Accreditation of Foreign Manufacturers of Medical Devices and IVD Reagents”

Office Memorandum, July 7, 2005 (PDF size 185Kb)
Q&A regarding required attachments for the application of “Accreditation of Foreign Manufactures of Medical Devices and IVD Reagents”

Note:
Notification by Yakushoku*
Yakushoku - Pharmaceutical and Food Safety Bureau at Ministry of Health, Labour and Welfare

Notification by Yakushokuki**
Yakushokuki - Office of Medical Devices Evaluation, Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau at MHLW

Notification by Yakushokuan***
Yakushokuan - Safety Division, Pharmaceutical and Food Safety Bureau at MHLW

For further information on Japan's Pharmaceutical Affairs Law and QMS requirements, please email us at sales.japan@bsigroup.com or contact BSI Japan on+81-3-6890-1177.



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