REGULATION

Brave new world: how to navigate
the new Japanese medical
device regulatory landscape
For more than 50 years, medical devices in Japan were regulated the same way as drugs. But all thischanged at the end of last year when a new legislation came into force, enabling devices to finally havea separate regulatory route which would hopefully expedite their entry to market. Masanori Otake*discusses the three most significant changes how devices are regulated and advises on how to navigate
the new landscape
On 25 November 2014, thePharmaceuticals and Medical Devices
Act (PMD Act) was enforced. The newact – officially known as the Act for
Ensuring Quality, Effectiveness andSafety of Pharmaceutical Products
and Medical Devices – amends andreplaces the Pharmaceutical Affairs
Law (PAL), which had been used forregulating medicines and devices alikesince 1960. The aim of the amendment
was not only to introduce new rules
for reinforcing the safety measuresfor devices and drugs, but it alsoestablished – for the first time – aseparate regulatory framework for
medical devices.
The details of the amendment arewide ranging and comprehensive, andthey are individually discussed. For
example, to reinforce safety measures,submission of package inserts forClass IV devices became obligatory;
in addition, the content description
on the package inserts and theoperation rules for all medical devices
were reviewed. Rationalization of
the application document content for
approvals and certifications, as wellas the procedures required forchanges and additions, are now being
reviewed in terms of their detailed
operational regulations.
Even in the short period between
the writing of this article in December
2014 and it being published, newoperation rules would have beenreleased and more updates made.
This article will highlight somechanges which could have significant
implications for medtech companies,
as well as potential remaining issues.
January 2015

as medical devices, and 3) evaluation
system on performance of usage.

Masanori Otake: The newrules have achieved more
fruitful, mutual discussions
between the Japanese
government and industry
associations
Key changes to Japanese
medical device regulation

The PMD Act introduces several
changes to the way medical devices
will now be regulated. Amongthese, the three most significant
are: 1) streamlining of the quality
management system (QMS) and theshift from a licensing system to aregistration system for the medicaldevice manufacturer, 2) the regulationof standalone (software) programs
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1) QMS and the shift from a licensing
system to a registration system
For the purposes of this article, it isimportant to clarify the difference
between “marketing authorization
holders (MAH)” and “manufacturers.”
Up till now, manufacturers ofmedical devices have been required toobtain a license. However, this step isno longer needed under the PMD Act;
instead, manufacturers are now only
required to register. Generally, alicense can be obtained after themanufacturer passes an examination;on the other hand, registration justentails the manufacturer submitting
the necessary information. But
while the required procedure for
manufacturers has been simplified, it is
not accurate to regard this change asjust a simple deregulation.
Medical devices are machines ormaterials, and the improvement cycle
for medical technologies is much
shorter than that of drugs. A systemthat is appropriate for managing suchproducts with frequent improvement
cycles would not need to individuallycontrol the manufacturing processesof each manufacturer. Instead, itwould look at the “whole” system of
manufacturing and quality control of thedevices. Based on this concept, having
manufacturers undergo a registration
procedure will be enough to maintainquality and safety of the products.
Consequently, the person in
charge of managing the whole quality
system of devices is obliged to be© Informa UK Ltd 2015

1

REGULATION

highly responsible. In this case,an MAH is supposed to assume
the responsibility. Therefore, anMAH, capable of obtaining productapproval and clearance, is responsible
for managing the whole quality
management system (QMS), including
manufacturer systems.
For manufacturers, the classificationof manufacturing facilities (general,sterilization, organisms, packaging
and labelling etc.) has been abolishedunder the new PMD Act. However,
the types of manufacturers havealso been revised. For example,
design manufacturers will need to beregistered.
In addition, the system’s operations
have been streamlined, including
the case that QMS examinations
can be omitted when the registered
manufacturing facilities (a combination
pattern, if multiple facilities exist)
and the products produced at
manufacturing facility have matchingproduct groups.
The updated system assumes thatan MAH is responsible for the QMS
and for managing manufacturers.
It is relatively easy to coordinate
steps when an MAH and amanufacturer exist as one company.
However, it becomes more complex
if a manufacturer was the parent
company located overseas, and theJapanese MAH is its subsidiary.
Legally, a manufacturing supplieris responsible for the whole QMS,
including the parent company’s
manufacturers, even if it is a subsidiary.
In reality, however, a subsidiarymust follow the policies of its parent
company (this is even more relevant
if the subsidiary has a relationshipwith another company based on just abusiness agreement). Sharing roles isrequired to bring together the need forcompliance and reality.
It is important to understandcarefully the details of the PMD Act
and clarify the sharing of roles between
a Japanese MAH and an overseas
manufacturer. Then, it would be possible
to streamline the quality management
system by properly organizing theregistered manufacturing facilities andthe product groups, as mentioned
earlier. Employees responsible formanaging the quality system at eachcompany are expected to act positively
in this aspect.
2January 20152) Standalone programs regulated as
medical devices
Under the previous PAL, standalone
programs could not be regulated as
medical devices but the amendment
has changed that. A standalone
program is defined as a program thatis installed on a PC for the purposeof being used as a medical device.
Previously this type of program was
not approved unless it was together
with PC hardware. However, theamendment now states that astandalone program “can be a medicaldevice” so can be regulated, approved
and sold as such. This puts Japan on
par with Europe and the US, wherestandalone programs are alreadytreated as medical devices.
That said, a standalone program inJapan does not mean a system control
program mounted on a medical device.
Therefore, a system control program
cannot be extracted for sale because
it needs to be approved as part of a
medical device.
For example, previously, a treatment
planning program used in radiotherapy
to determine radiation dose andpositioning would not have beenaccepted as a medical device. This isbecause under the legal interpretation,a program itself cannot provide
treatment. Pursuant to the amendedact, however, such a program shall beaccepted as a medical device. Similarly,
due to the recent fitness boom, a large
number of programs relating to healthand medicine have become widely
available on smartphones or tablet
devices. There is the possibility thatsuch programs are (or, can be) accepted
as medical devices depending on theirclaims and risks. For programs originallydeveloped for medical purposes, asinitially mentioned, specific contents ofapplication documents are now underreview. For programs where it is difficult
to judge whether they can or cannot
be accepted as medical devices, thecriteria to determine their eligibility
is continuously under discussion.
Particularly in the IT field, there is also
a possibility that unexpected programs
will be developed. The Japanese
government is, together with industry
associations, required to formulate
an operation rule that is flexible andnot bound to the existing regulations
with hardware based on the uniquecharacteristics of programs, in order towww.clinica.co.uk

allow real technology development inthis field. On the other hand, applicantsneed to ensure they keep up withthe trend of relevant regulations andoperation rules.
It is important to note that programs
which correspond to Class I medical
devices would not be regulated as
devices and therefore need not besubmitted for regulatory clearance.
However, discussions with theregulatory authority must still be
conducted on how to advertise theeffectiveness of these programs.
Operations have already begun underthe voluntary guidelines created byindustry associations for programs not
accepted as medical devices. So the key
to success for new players in this field is
to “use” the regulations in considering
their individual business strategy.
3) Evaluation System on Performanceof Usage
The Post-Marketing Surveillance
System (PMS) has been renamed the‘Evaluation System on Performance ofUsage’ under which each applicable
case and the duration of each case is
now determined individually.
Under the previous PAL, it wasuniformly specified that the applicable
cases were all “new medical devices”,
and that the applicable period shouldbe, in principle, three years (four yearsfor new structure medical devices;seven years for medical devices thatare used to treat rare diseases). This is
now changed under the new Evaluation
System on Performance of Usage of
the PMD Act, so that the applicable
medical device and the surveillance
period can be specified for each case.
In other words, there is a possibility
that while a “new medical device” may
not be subject to the new Evaluation
System, an “improved medical device”
may be subject to the evaluation.
This shall be judged in the productreview process and will depend on thedevice’s individual characteristics.
This system change has givenrise to pros and cons. While it isreasonable that the system is not
uniformly applied, potentially, thiswill depend on the judgment madeby the Pharmaceuticals and Medical
Devices Agency (PMDA) reviewers or
the reviewing doctors requested by
the PMDA. It would then be harder topredict the burden of the evaluation© Informa UK Ltd 2015

REGULATION

system on performance of usage
for which heavy cost is required.
Therefore, the government andindustry associations will be required
to hold in-depth discussions in thefuture to clarify the judgment criteriaof the applicable case of the evaluationon performance of usage and thetransparency of the decision process.

Conclusion

Prior to the PMD Act, the last
amendment to the PAL was enacted
in 2002. At that time, companies weregiven a transition period of three years
before the amended PAL came intoforce. With the PMD Act, the transition
between promulgation and enforcement
has only been one year. As a result,the act has been enforced without
sufficient review of the actual operation.
In terms of QMS, some problems
remain unsolved regarding the actual
method of surveillance. Other issues
may also be identified after operations
are conducted. These issues may be inareas such as the unit programs and theevaluation system on performance ofusage as mentioned previously.
That said, compared with theJanuary 2015previous amendment in 2002, it seems
to have achieved more fruitful, mutual
discussions between the Japanese
government and industry associations
aiming to specify the operation rules
based on the concepts of the new
PMD Act. A remaining challenge will
be whether both the applicant andthe reviewer (especially the PMDA
and the third-party certification agentsi.e. notified bodies) can implementa reasonable operation that keeps inmind what is most needed. Medical
devices are no longer managed under
the PAL, which had previously followed
the rules for pharmaceutical products.
The applicant is now responsible andauthorized to develop their medical
devices and apply for approval byunderstanding the purpose of therelevant regulations and complying tothese new requirements; conversely,
the reviewer is required to make new
judgments in accordance with thespecific characteristics of medical
devices, and not take into accountreview precedents that had applied
to previous drug regulations. It should
also be noted that the development
and submission of medical devices

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will not be achieved without aprofitable business.
In conjunction with theamendment, the action programaiming to accelerate product reviews– which was implemented for fiveyears – was renamed as a five year
“collaboration plan” in 2014, to
support the acceleration of productreviews. The number of PMDA
reviewers has increased as planned,
but an improvement in submission
procedures and review quality is stillrequired. Proper implementation by“collaboration” will be the key forsuccess of this amendment.
*Masanori Otake is the chairmanof the regulatory affairs and quality
assurance committee at American
Medical Device and Diagnostics
Manufacturers’ Association in Tokyo.
He is also regulatory affairs and policy
manager, healthcare, at GE Japan. For
more information, contact the AMDD
at http://amdd.jp/en/index.html
This article was first publishedby Clinica Medtech Intelligence(www.clinica.co.uk) on 26 January 2015.

© Informa UK Ltd 20153