Japan s lucrative medical device market is still the second largest in the world, ahead of china and germany. The term medical device as used in this law refers to medical. These groups of products are listed under annex xvi of the medical device regulations mdr. Japan is the second largest medical device market in the world, with. Key topics include pmda consultations, device classification, foreign manufacturer registration, japanese gcp, product reimbursement, how to expedite product registration and maximize the use of foreign clinical. Marketing and distributing medical products in japan. For example, legal terms and their meanings are sometimes nonuniform even within one regulatory system. Medical devices regulations 238 kb pdf full document.
Requirements for conducting specified manufacturing processes. United states in the united states, the federal food drug and cosmetic act regulate the medical device. It remains a key focus for medical device manufacturers looking to expand their international operations. Amendments to the japanese pharmaceutical affairs law. Information on the great east japan earthquake from prime minister of japan and his cabinet link to prime minister of japan and his cabinet. David jefferys, a medical device expert and senior vice president for global regulatory, healthcare policy, and corporate affairs at eisai europe, ltd.
To keep abreast of the constantly changing medical device industry in japan, the japanese government has significantly revised its pharmaceutical affairs laws. General overview of the brazilian regulatory framework 3. The pmd act affects major areas of medical device regulations, including quality management system compliance, device registration, the regulation of medical software, and thirdparty certifications. May 04, 2010 medical device and fda regulations and standards news. The international medical device regulators forum1 imdrf is an organization comprised of medical device regulators from australia, brazil, canada, china, the eu, japan and the usa with the desire to accelerate global medical device regulatory harmonization and convergence. The japanese quality management system requirements are similar to. Japan medical device regulations all documents listed below were published by the ministry of health, labour and welfare mhlw or the pharmaceutical and medical devices agency pmda and are in pdf format. Issuance of certificates for medical devices for export. Registration of medical devices has always been a complex, timeconsuming, and expensive process. Japan s market for medical devices and materials continues to be among the worlds largest. Registration and listing registration of establishment. Medical devices regulations list of high impact articles. Pharmaceutical laws and regulations devices came into effect on april 1, 2005. A medical device kit means two or more medical devices in one packing unit.
The pharmaceutical and medical devices agency pmda offers consultations to give guidance and advice on clinical trials and data for regulatory submissions. Japan medical device regulatory updates and recent revisions. Japan medical device regulations all documents listed below were published by the ministry of health, labour and welfare mhlw or the pharmaceutical and medical devices agency pmda and are in. Japan market in medical devices and invitro diagnostics. South africa medical devices regulatory systems at country level. List of medical device regulatory documents published by the japanese.
Japan is one of the most established medical device markets globally. All medical devices and equipment have to go through a mandatory set of tests, even though the same tests have been performed during a process. Mdsap international regulations english australia, brazil. Medical device cyber security testing and assessment services. Pmda japan and medical device regulation tuv sud tuv sud. Acceptance of medical device foreign clinical data. Requirement for marketing any new medical devices and ivds in japan.
For the most comprehensive and detailed overview of the japanese medical device regulations, view the japan medical device regulations webcast. The global medical device regulatory market is quickchanging, but with raps global medical device regulations, second edition, in secure pdf format, youll find the answers to all of your questions from your tablet, laptop or smart phone. Pharmaceuticals and medical devices agency pmda 12 fig. A guide for importing medical equipment into brazil. Medical device regulations and utilization of international standards in japan katsuhisa ide div. Note 5 of the specific maintenance management medical devices, for large medical devices, such as installation controlled medical devices specified in paragraph 1, article 93, ordinance for enforcement of the pharmaceutical affairs act, the individual package marking shall be made optional. Pharmaceutical administration and regulations in japan. The regulation of medical devices in the european union 1. A device is defined as an instrument or apparatus intended for use diagnosing, curing, or preventing diseases in humans or animals, or intended to affect the structure or functions of the bodies of humans or animals. Before sharing sensitive information, make sure youre on a federal government site. The global framework for regulation of medical devices. Understanding japanese medical device requirements pmda. This file contains information concerning pharmaceutical administration, regulations, and new drug development in japan updated annually by the. Devices with extremely low risk to the human body in case of problems ex in vitro diagnostic devices, steel made small devices including a scalpel, tweezers, xray film, devices for dental technique general medical device.
Manufacturers must obtain a license, import andor export a medical device andor ivd in south africa. Switzerland the eu single market for medical devices 2. The three pathways to medical device registration in japan in asian market, regulatory by chikako kitayama november 17, 2016 the medical device industry in japan is one of the most attractive markets in the world, and has undergone tremendous growth in the last several years. An overview of medical device regulations in japan regdesk. Pharmaceutical administration and regulations in japan this file contains information concerning pharmaceutical administration, regulations, and new drug development in japan updated annually by the english ra information task force, international affairs committee, japan pharmaceutical manufacturers association jpma. Regulations on medical device, based on risk 4 medical device category in japan class i general mds xray film class ii controlled mds mri, digestive catheters class iii specially controlled mds artificial bones, dialyzer class iv specially controlled mds pacemaker, artificial heart valves ghtf classification and medical device category risk. The regulation of medical devices in the european union. In the case of medical devices, the design, main assembling, sterilization and domestic japan distribution site shall be registered. Nov 17, 2016 the three pathways to medical device registration in japan in asian market, regulatory by chikako kitayama november 17, 2016 the medical device industry in japan is one of the most attractive markets in the world, and has undergone tremendous growth in the last several years. Medical devices regulations 555 kb regulations are current to 20200305 and last amended on 20191216.
Can overseas clinical data be used for medical device approval. The three pathways to medical device registration in japan. Various regulations apply to the development, manufacture, import, marketing, and proper use of drugs and medical devices in the form of the pharmaceutical and medical device act, cabinet orders, mhlw ordinances, etc. Japan medical device regulations updates 2014 webcast slides. Free to download eu medical device classification form. Frequently asked questions faq application for product approval. New regulation in japan and future direction of pmda dr. Update on medical device and ivd regulation in japan. Jan 20, 2019 the japanese medical device market is one of the largest in the world, behind europe and the united states. Do you know the requirements and your responsibilities for. Qms quality management system for medical device in japan.
Improved medical devices clinical trial data required this category is for medical devices that 1 do not have an applicable approval standard or do not meet the requirements of the approval standard. New japan medical device regulations medtech intelligence. We have created an interactive guide to the new eu regulations for medical devices mdr and in vitro diagnostic medical devices ivdr pdf. The conclusion of this thesis is that most countries have similar requirements for. Selling a medical device in japan requires manufacturers to comply with the japanese pharmaceutical and medical device act pmd act and its corresponding registration process. In order to market medical devices in japan, manufacturers must be compliant with the current pmd act. Japan is the second largest medical device market in the world, with medical devices imported from outside of japan representing a substantial percentage of total market share. Ivd regulation in japan 2 reagents drugs analytical medical device ivd ghtf pharmaceutical and medical device act in japan ivd reagents are regulated under the rules based on the medical devices.
The former regulation, japanese pharmaceutical affairs law jpal was replaced by pmd act on november, 25, 2014. October 23, 2019mhlw pharmaceuticals and medical devices safety information no. Ghtf sg1 label and instructions for use for medical. Revision of japanese medical device qms requirements. Soliris partial change approval october 17, 2019report of the pdg. Japan is an economic powerhouse, and its medical device market is one of the biggest in the world. Medical device companies interested in offering their products in japan must comply with japan s pharmaceuticals and medical devices. Quality management systems for medical device manufacturers. These changes, which include increases from 8 to 15 percent, are effective 01 april 2018. Learn about japan medical device and pharmaceutical regulations under the pharmaceuticals and medical devices act pmd act, including the role of the pmda and mhlw agencies, the regulatory approval process for devices and drugs, and the latest developments and news in the field. A medical support stocking that is intended to prevent the pooling of blood in the leg is a class ii medical device and requires a premarket notification. South africa medical devices regulatory systems at country. Some figures on the eu medical device sector over 500 000 types of medical and in vitro. The document is intended to provide nonbinding guidance for use in the regulation of medical devices, and has been subject to consultation throughout its development.
Ensure your networked medical devices conform to cyber security requirements according to medical device regulations. Additionally, the mfds defines several subsets of medical devices in the medical device approval regulations, as follows. Pharmaceutical laws pharmaceutical administration in japan is based on various laws and regulations, consisting mainly of. Heres an example of a regulation and how product codes play a part in the regulation classification of a medical device. Regulatory information pharmaceuticals and medical. Pharmaceutical administration and regulations in japan this file contains information concerning pharmaceutical administration, regulations, and new drug development in japan updated annually by the english ra information task force, international affairs committee, japan. In europe general medical devices are divided into non invasive devices, invasive devices and active devices. Marketing authorization for medical device on 29 october 2007. Jul 30, 2019 its a fillable pdf where you can provide all the information of your medical device and select which classification is applicable.
Medical devices can in turn be regulated as one group or regulated separately, usually as one of the subgroups. In the same way, regulation of medical devices manufactured outside of japan was transferred from an accreditation system to a registration system. The term medical device as used in this law refers to medical appliances or instruments excluding regenerative medicine products intended for use in the diagnosis, treatment or prevention of disease in humans or animals, or intended to affect the structure and functions of the. New regulations of noncorrective colored contact lenses under the pharmaceutical affairs law issuance of certificates for medical devices for export revision of japanese medical device qms requirements. Many of the changes discussed above will help more foreign medical device companies get their products on the japanese market sooner. The contents are not abstracts of governmental rules or regulations but concise descriptions of most. Medical devices regulations 555 kb regulations are current to 20200305 and last amended on 201912. Japan medical device regulations published by japanese pmda. Diagnostic reagent is included in the definition of a medical device see above. Regulations for building and facilities, must be met by the medical devices manufacturers in order to obtain accreditation by mhlw as a foreign manufacturer.
Pmda medical device registration and approval in japan. The major product categories comprising japans domestic medical device production include. A holder of marketing authorization for medical devices or invitro diagnostics shall, when intending to market medical devices or invitro diagnostics notify the minister of health, labour and welfare thereof for each such item beforehand, pursuant to the provisions of an ordinance of the mhlw. Legislation and guidelines medical devices acts and regulations the therapeutic products directorate tpd applies the food and drug regulations and the medical devices regulations under the authority of the food and drugs act to ensure that the pharmaceutical drugs and medical devices offered for sale in canada are safe, effective and of. A guide for importing medical equipment into brazil 1. Japanese medical device companies maintain high market share in these product segments. Current japanese regulatory systems for generics and. Gain an understanding of the roles of the mhlw and pmda in medical device registration, the process leading to approval, or shonin, classifications for medical devices, and other requirements such as documentation and clinical trials. The distribution of medical devices in japan is regulated in accordance with the pharmaceutical and medical device act pmd act regulation by the ministry of health, labour and welfare mhlw.
Understanding the regulatory requirements of the japanese medical device market. Revise medical device regulations based on its characteristics 3. Bsi is designated as an rcb for all class ii and designated. It is important that foreign medical device manufacturers study these new regulations so they can use them to their advantage to succeed in the japanese marketplace. The term medical device as used in this law refers to medical appliances or instruments excluding regenerative medicine products intended for use in the diagnosis, treatment or prevention of disease in humans or animals, or intended to affect the structure and functions of the bodies of humans or animals, as specified by cabinet order. Find out how tuv suds services help your organisation assess and test devices to assure conformity to the eu mdr and other global requirements like the us fda, china fda and the japan ministry of health and welfare. Overview of riskbased medical device regulations in japan. Procedures for developing postmarketing study plan. Jan 29, 2014 to the metoo medical device section below improved medical devices clinical trial data not required and not compliant with approval standards this category is for medical devices that 1 do not have an applicable approval standard or do not meet the requirements of the approval standard. For companies that want to tap into small and mediumsized markets in japan, the best strategy is probably to export to a japanese importer or distributor.
New regulation in japan and future direction of pmda. Oct 01, 2004 the japanese medical device evaluation system the definition of a medical device in japan is similar to the u. An introductory guide to the medical device regulation mdr. On 31 january 2018, japan s pharmaceuticals and medical devices agency released cabinet order no. Japanese medical device regulations the certification process. This process is overseen by the pharmaceuticals and medical devices agency pmda, a division of the ministry of health, labour and welfare mhlw.
Shinkasumigaseki building, 332 kasumigaseki, chiyodaku, tokyo 0 japan. Japan s requirements for reporting medical device adverse events. Marketing and distributing medical products in japan mddi. The regulation of medical devices is a vast and rapidly evolving field that is often complicated by legal technicalities. Japanese medical device qms requirements and other related regulatory information. Information on the great east japan earthquake from ministry of health, labour and welfare. Japan regulatory approval process for medical devices. Current japan pmda regulations are laid out in the pharmaceuticals and medical devices act pmd act, also known as the act on securing quality, efficacy and safety of pharmaceuticals, medical devices, regenerative and cellular therapy products, gene therapy products, and cosmetics. Adverse event and serious adverse event reporting korea. International classification risk base medical device classification classification risk level type of regulation.
Legal national regulatory authority medical device definition. Strengthen safety measures regarding drugs and medical devices 2. Japans pmda to raise medical device and ivd registration. Medical device regulations and utilization of international. Japan medical research development institution act 2014. That said, despite being a very technologically developed country that is home to many large, multinational medical device corporations, a high percentage of the medical devices marketed and sold in japan come from foreign manufacturers. A medical device combination means two or more medical devices combined into one medical device, which exercises combined functions. Medical devices should be designed and manufactured in such a way that, when used under the conditions and for the purposes intended and, where.
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