J-PAL Overview
and Update
Boston, USA
2013-10-02
Rie Nakahara
Manager, Active Medical Devices
TUV SUD Japan
TÜV SÜD Japan
13-09-27
Slide 1
Contents for Today’s Presentation
-
PAL Overview
- Updated Information on Revised PAL(Draft)
TÜV SÜD Japan
13-09-27
Slide 2
Contents for Today’s Presentation
-
PAL Overview
- Updated Information on Revised PAL(Draft)
TÜV SÜD Japan
13-09-27
Slide 3
Japanese Regulation System
TÜV SÜD Japan
0
0. Constitution
1
1. Law (e.g. PAL)
2
2. Governmental Ordinance
3
3. Ministerial Ordinances
4
5
6
4. Ministerial Notices
5. Announcements
6. Office Memos
13-09-27
Slide 4
1. Pharmaceutical Affairs Law (YAKUJI-HO)
v
v
v
v
Established on 10 August 1960
Major revision on 31 July 2002
Minor revision on 11 June 2003 (The latest)
Both of the revisions in 2002 & 2003 are effective on 1 April 2005
v Scope
Ø Drugs (Medicine) including In-vitro
diagnostic reagents
Ø Quasi-Drugs (Sanitary & toiletry products)
Ø Cosmetics
Ø Medical devices
TÜV SÜD Japan
13-09-27
Slide 5
Terminology
Abbreviatio
Formal notation
ns
meaning
Japanese Industrial
Standard
National standard in Japan
Most of JIS are identical to international standard (ISO or IEC), but a few JIS are
not identical nor modified.
JIS is used for certificate assessment criteria of Medical Device for
certification
JMDN
Japanese Medical
Devices Nomenclature
code
Code assigned to each medical device term based on GMDN code
JGMP or
J-GMP
Japanese Good
Manufacturing Practice
rule
MHLW Ordinance No. 169 in 2004
Some of governmental officers want to abbreviate the ordinance as “QMS
ordinance” or “QMS rule”, but we use this abbreviation.
MAH
Marketing
Authorization Holder
An organization that has legal responsibility in Japan
Similar to “legal manufacturer” under MDD or CMDR
MHLW
Ministry of Health,
Labour and Welfare
Japanese government, which is responsible for the medical attention
Pharmaceutical Affairs
Law
Law, regulating Drugs (Medicine) including In-vitro diagnostic reagents, Quasi-Drugs (Sanitary &
toiletry products, Cosmetics and Medical devices
Pharmaceuticals and
Medical Devices
Agency
An Independent Administrative Legal Entity, which is responsible for approval of
all of medicines, a certain type of medical devices and IVD reagents
Registered
Certification Body
under PAL
Third party, who has authority to certify a certain type of medical devices and IVD
reagents.
13 RCBs exist in Japan as of 2013 Oct. TUV SUD J is one of them
JIS
PAL
PMDA
RCB
TÜV SÜD Japan
13-09-27
Slide 6
PAL Scheme
Product Certificate
Class II
RCB
Application doc. (STED)
MAH
Controlled
(Contract)
Japan
Class III / IV
J-GMP audit (QMS)
Manufacturing site
TÜV SÜD Japan
13-09-27
Slide 7
Current Change System
Change Type
Actions
Significant Change
Significant Changes on device configuration,
materials, performance ;
New Application is necessary
Partial Change
Application
Review by PMDA or RCB is necessary
Approval of Certification is necessary, before
the changed devices is marketed in Japan
Minor Change
Notification
Just Notification
Approval or Certification is NOT necessary.
Relevant announcement Yaku Shoku Kihatsu No.1023001
‘ Procedures for Changes of Medical Devices ‘ issued on Oct 23, 2008
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13-09-27
Slide 8
Marketing Approval or Certification
IVD
reagents
Medical
Devices
Both are not necessary
(Notification to PMDA)
Class I
Class II
Approval or
Certification
If certification
assessment
criteria is
available
If certification
assessment
criteria is
available
Certificate application to
RCB
If not available
If not available
Approval application to
PMDA
Class III
Approval application to
PMDA
Class IV
TÜV SÜD Japan
13-09-27
Slide 9
PAL in comparison to Other Regulations
Involved
Organizations
Product
Safety
QMS
Vigilance
USA
FDA
3rd Party reviewer
510 (k)
PMA
QSR
MDR
Japan
MHLW
+ PMDA
& Local Gov
(Prefecture)
+ 3rd Party(RCB)
Approval or
Certification
QMS/GMP
(≠ISO13485)
Adverse
event
reporting
EU
Competent
authorities of
member states
Notified Body
MDD
CE Marking
MDD
EN ISO13485
MDD
Vigilance
System
Canada
Health Canada
Registrar
CMDR Device
License
CMDR
ISO13485
CMDR
TÜV SÜD Japan
13-09-27
Slide 10
Contents for Today’s Presentation
-
PAL Overview
- Updated Information on Revised PAL(Draft)
TÜV SÜD Japan
13-09-27
Slide 11
PAL will be revised soon
・Decision @ Cabinet Meeting was made in 2013 May
・Movement to Revised PAL
Due to insufficient deliberation, revised PAL was not concluded in
the Regular Diet Session (No. 183) till 2013/06/26 .
Revised PAL will be taken into deliberation in the Next
extraordinary Diet Session in Mid October 2013.
Revised PAL will be named
’Law for Ensuring Quality, Effectiveness and Safety of Medicines,
Medical Devices and So On’
TÜV SÜD Japan
13-09-27
Slide 12
Why PAL needs to be to revised ?
Pharmaceutical Affairs Law
Medical
Device
Drug
e.g. For active Medical Devices, aggregate of
electrical engineering technologies. Develop
with repeated design and improvements.
Once the constituents of chemical
compounds, changes are seldom
happened.
Control under the same Provision
Law for Ensuring Quality, Effectiveness and
Safety of Medicines, Medical Devices and So On’
Control under separate provisions
TÜV SÜD Japan
13-09-27
Slide 13
Medical Devises V.S Drug
Medical Device
Drug
Company Size
Medium and small sized
companies (about 80%)
Multinational, global companies
Product Types
About 300,000 items
17,000 items
Usage
Technique is required
Usage and Dosage Control
Effectiveness
Also depends on user’s
techniques
Depends on individual difference
Materials
Various materials, material
technologies involved
Natural substances, chemicals
Design and
Development
Upon Market Needs, have
design change & improvement
No Change after being Marketed
Life cycle
18-24 months (for shorter ones)
e.g. more than 10 years
Maintenance・
Repair
Necessary
NOT Necessary (Storage Control
Only)
Regulation
Currently PAL
(Quoted from MHLW issued materials, Mizuho Bank ‘Mizuho Short Industry Focus 2013/07/22)
TÜV SÜD Japan
13-09-27
Slide 14
Please Keep In Mind……
The Contents of this presentation does NOT reflect the final fixed
version of revised PAL . Information will be changed and updated.
Please pay attention to the updated information
Although determined at Cabinet Meeting, the revised PAL is still NOT yet
deliberated.
• Revised PAL (Draft) is under active discussion
• Concrete and Detailed implementations are still NOT determined yet.
Additional new bullet points might be added.
TÜV SÜD Japan
Slide 15
Bullet Points of Revised PAL
1. Constructing regulatory scheme, considering characteristics of
Medical Devices.
2. Encourage New Entry into Medical Device Market
(Promoting design and development of Medical Devices,
Faster Review Process, Liability Relief)
3. Global Harmonization
TÜV SÜD Japan
13-09-27
Slide 16
Bullet Points of Revised PAL
1. Constructing regulatory scheme, considering characteristics of Medical
Devices.
Time consuming Change System
Partial Change : Preparation of Documents, Submission,
Review and Approval
Simplify Partial Change System
・Design Control will be audited in QMS on-site audit for all Medical Devices.
(Design Change is reviewed on-site)
・MAH is also audited for QMS (Now only for Manufacturing Sites)
TÜV SÜD Japan
13-09-27
Slide 17
Image
B
A
Current
B
A
Future
A：J-GMP audit (QMS) :
B：Device change (Partial Change)
TÜV SÜD Japan
13-09-27
Slide 18
Bullet Points of Revised PAL
2. Encourage New Entry into Medical Device Market , Liability Relief
(Promoting design and development of Medical Devices, Faster Review
Process)
a) For Manufacturer’s License :
-Registration / FMA (Foreign Manufacturer Approval) →Listing
• Company only doing design and development:
-Listing will be necessary.
TÜV SÜD Japan
13-09-27
Slide 19
Bullet Points of Revised PAL
Foreign Manufacturer Registration
(Under Current PAL scheme)
TÜV SÜD Japan
13-09-27
Slide 20
Form to be submitted to PMDA( Under JPAL)
•
•
Address in Japanese
and local language.
(in case of legal entity,
the main office’s)
•
•
•
•
•
•
Name in Japanese
and local language.
(in case of legal
entity, the name of
company and
president)
TÜV SÜD Japan
•
•
•
13-09-27
Form No. 18
Application for Registration of Foreign Manufacturing
site of
(Medicines, Quasi-Drugs, Medical Devices)
Name of the site
Location (address) of the site
Category of registration
Outline of building and facilities
Responsible person of the site
– Name
– Private address
Disqualification clause of Applicant (in case of legal
entity, describe its board members)
1. Has it been canceled the license or registration?
2. Has someone been assigned penalty of prison or
over?
3. Has someone violated PAL or related regulations?
4. Is someone in the dock of commencement of
guardianship?
Note
Statement “Hereby, I apply for the registration.”
Date
Slide 21
Documents to be attached
1. Medical certificate that describes if the applicant (in case of legal entity, the board member) has
mental illness or be addicted to drugs
2. Job history of the responsible person at the site
3. List of manufacturing products (i.e. products scheduled to be exported to Japan) and Description
of manufacturing process
4. Description of building and facility in the manufacturing site
5. If radioactive medicine is manufactured, kind of the radioactive medicine and summary of
equipment to deal the radioactive medicine
6. If the country, where the manufacturing site located in, has system license of MAH, manufacturing
site, approval or certificate of product, or equivalent, a copy of such license or approval/certificate
• The MAH can take manufacturing site’s duty for application of registration.
TÜV SÜD Japan
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Slide 22
• b) Expansion of Certification Scope of 3rd Party (RCB)
Classification
Definition
Examples
Current
Future
TÜV SÜD Japan
Class1
Class 2
Class 3
Class 4
Extremely little risk to
the human body even
if they fail
Relatively little risk to
the human body even
if they fail
Relatively high risk
to the human body if
they fail
Medical devices that
are highly invasive
upon the patient and
may directly
endanger the
patients’ life if they fail
IVD Instrument,
Surgical Knife・
Forceps, X ray Films
Ultrasound Equipment, Dialyzer, respirator
Blood Pressure Meter
(Electrical), MRI
Notification
Notification
13-09-27
3rd Party
Certification
3rd Party
Certification
Pace Maker, Artificial
heart valve
Approval （Reviewed by PMDA）
Approval
（Reviewed by
PMDA）
Slide 23
Bullet Points of Revised PAL
2. Encourage New Entry into Medical Device Market , Liability Relief
(Promoting design and development of Medical Devices, Faster Review
Process)
• C)QMS Audits will be streamlined
-QMS conformity attestation (in Japanese, Kijun Tekigo Sho)
will be issued to QMS including MAH and manufacturers for the
product category.
-Audit is NOT done by prefectures any more
TÜV SÜD Japan
13-09-27
Slide 24
Image of Kijun Tekigo Sho (QMS Conformity Attestation )
MAH
Manufacturer
Design Facility
MAH
Sterilization
contractor
QMS Conformity Attestation is issued
(for Product Category)
TÜV SÜD Japan
13-09-27
Packaging
Contract
Design
Foreign Manufacturing
Site
Sterilization
Contractor
QMS Conformity Attestation is issued
(for Product Category)
Slide 25
3. Global Harmonization
Stand alone Software will be regulated
Current J PAL
Revised PAL
Stand alone software
Changed to
Software part
（program）
Hardware
part
Software alone itself is NOT regulated
under current JPAL .
Regulated with combination of software
and hardware part.
TÜV SÜD Japan
13-09-27
Software Part
（program）
Program itself will be regulated.
※already regulated as Medical
Device in EU, and USA
Slide 26
Intended
for
diagnosis
and
treatment
Category
Software as
part of Medical
Device
Stand alone
Medical use
Software
Definition
Product Example
Embedded Software in to Medical
Device
Embedded software into CT
Optional Software for Medical
Devices
Software installed for Medical
Work Station (Separately Sold)
Application software for Medical
use ①
Software alone has the
Effectiveness for Medical purpose,
and intended for diagnostics. Sold
as software alone, intended to be
installed in the general purpose
hardware such as personal
computer etc.
Software currently regarded as
Non Medical Devices
Application software for Medical
use ②
Processing of patient clinical
information and image information
collected from Medical Devices is
NOT done. However, for diagnostic
purposes, intended for data
storage, transfer, or displaly.
Includes. Sold as software alone,
intended to be installed in the
general purpose hardware such as
personal computer etc.
Software currently regarded as
Non Medical Device
e.g. PACS(Picture Archiving and
Communication System), Server
software, biological test software
Japan
EU
USA
※
○
○
○※
○
○
×
↓
○
○
○
×
↓
○
○
○
※Regulated as software installed Medical Devices
TÜV SÜD Japan
13-09-27
Slide 27
Bullet Points of Revised PAL
3. Global Harmonization
Current QMS : ≠ ISO 13485 (some delta parts)
Revised : ＝ISO 13585 (????), JGMP Chapter 3 is deleted
TÜV SÜD Japan
13-09-27
Slide 28
Summary of Revised JPAL
Points
Current PAL
Revised PAL (Draft)
Expected Effects
Manufacturer License License / Registration Listing
Encourage new entry
Expansion of
Certification Scope of
3rh party
Class 2 with
conformity
assessment criteria
Faster Review
Process
Product Scope
Change
Stand alone Software Stand alone Software is
is NOT in the scope
in the scope of revised
of current PAL
PAL
QMS Audit
Product based
Product Category
Streamline QMS
with the concept of Kijun Faster Review
Tekigo Sho (QMS
Process
Conformity Attestation
≠ ISO 13485
(Delta Parts)
＝ISO 13485 (?????)
Chapter 3 will be
deleted
TÜV SÜD Japan
13-09-27
Current Class 2 Plus
Part of Class 3
Global Harmonization
Activate design and
development of
standalone software
Global Harmonization
Slide 29
Current Situation
• Decision on Revised PAL was made @ Cabinet Meeting on 24 May
2013
• Due to insufficient deliberation, revised PAL was not concluded in
the Regular Diet Session (No. 183) till 2013/06/26 .
• Revised PAL will be taken into deliberation in the Next extraordinary
Diet Session in Mid October 2013.
• Date of Enforcement : The date, which will be defined in the
government ordinance within one year after the promulgation
TÜV SÜD Japan
13-09-27
Slide 30
Will the PAL Really be Revised ?
On 2013/07/26, the MHLW Vice Minister, Mr. Kenya Akiba, visited TUV SUD Japan
MHS and obtained information on current RCB task and our implementation.
MHLW Vice Minister
Mr. Kenya Akiba
TÜV SÜD Japan
13-09-27
TUV-SUD Japan CEO
Dr. Andreas Stange
Slide 31
TUV SUD Japan Activities for the Revised PAL
• As ARCB (Association of Registered Certification Body) Rep.,
-Actively participate in opinion exchange sessions with MHLW and
industry
-Negotiate several certification issues with MHLW
- A member of ‘Medical Device Task Force’, ‘ QMS Working Group’, and
‘ Product Category Study Group’
(Ms. Eiko Tabuchi)
• -A member of Stand Alone Software Study Group for the Revised PAL
(Mr. Kenji Kino, and Mr. Yukihiro Nakata)
★Only TUV SUD Japan and UL Japan out of 13 RCB, participate in this
study group
TÜV SÜD Japan
13-09-27
Slide 32
For Updated Information
- Med-Info. will be issued once the revised PAL is
finalized after the Diet deliberation
http://www.tuevsued.de/industrie_konsumprodukte/tools_und_do
wnloads/broschuerendownload/medinfos
TÜV SÜD Japan
13-09-27
Slide 33
ありがとう
Thank you for your attention!
감사 합니다
谢谢
ขอบคุณ
Cám ơn
Terima kasih
Merci
Danke
Obrigada