Japanese Pharmaceutical Affairs Law (PAL) doc and "Essential Principle Checklist"

Q

QMLady

#1
Hi there,
I am wondering if anyone can help mit with the japanese PAL.

As a medical device manufacturer we have to go conform with the japanese PAL as we sell products to Japan.
I already have found several ordinances (such as number 169, number 2, number 136) describing the quality management system requirements to find out the differences to the ISO 13485.

But I cannot find any document describing the PAL.
Can anyone give me a hint where I can download it?

Does anyone know anything about the "essential principle checklist"?

:thanx: for your help.
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#3
Hi there,
I am wondering if anyone can help mit with the japanese PAL.

As a medical device manufacturer we have to go conform with the japanese PAL as we sell products to Japan.
I already have found several ordinances (such as number 169, number 2, number 136) describing the quality management system requirements to find out the differences to the ISO 13485.

But I cannot find any document describing the PAL.
Can anyone give me a hint where I can download it?

Does anyone know anything about the "essential principle checklist"?

:thanx: for your help.
Hi,

I think you might find what you're looking for in this thread:

http://elsmar.com/Forums/showthread.php?t=9317

(Scroll down to post #10 and below)

Cheers,
Ronen.
 
Thread starter Similar threads Forum Replies Date
E IVD Classification in Japan based on the Japanese Pharmaceutical Affairs Law Japan Medical Device Regulations 2
P Japanese Pharmaceutical Affairs Law (JPAL) Internal Audit Checklist Quality Manager and Management Related Issues 4
AnaMariaVR2 2011 Top 10 Players in the Japanese Pharmaceutical Market US Food and Drug Administration (FDA) 0
B Purchasing AS9100D Standard in Japanese AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
K Comparator drug with Japanese label use in Clinical trials? US Food and Drug Administration (FDA) 0
I Japanese medical device recall requirements & procedure for foreign manufacturers Japan Medical Device Regulations 4
M Are English translations required for Japanese Certs Japan Medical Device Regulations 1
Y How to distribute CE marked product for Japanese market? EU Medical Device Regulations 3
I UDI requirements vs Japanese Barcode Marking guideline Japan Medical Device Regulations 1
W Japanese Steel Specifications - A material called HNCM220M Manufacturing and Related Processes 1
R Japanese Requirements for Medical Devices - JPAL Ordinance 169 + "law" references Japan Medical Device Regulations 5
AnaMariaVR2 FDA Puts Japanese Manufacturer on Import Alert after Disastrous Inspection US Food and Drug Administration (FDA) 1
Z How does Japanese Customs Clear and Control Devices shipped into Japan? Japan Medical Device Regulations 3
S Need help with Japanese Specification - Wire callout of "SWIC-F-SW-C" Customer and Company Specific Requirements 4
R Why 7 & 3 are in most of the Japanese Tools Misc. Quality Assurance and Business Systems Related Topics 8
M Why Japanese are ahead? Misc. Quality Assurance and Business Systems Related Topics 27
C 5S Pictures with Seiri, Seiton, Seiso, Seiketsu and Shitsuke in Japanese Coffee Break and Water Cooler Discussions 3
B New Japanese automotive launch (composite plastics molding) - Acceptable Cpk? Capability, Accuracy and Stability - Processes, Machines, etc. 12
Q JMDN (Japanese Medical Device Nomenclature) codes list needed Japan Medical Device Regulations 23
Crusader Hosting Japanese Business Visitors - Need the Cove members advice / opinion Travel - Hotels, Motels, Planes and Trains 43
M Japanese rule on EtO residuals in sterilized medical devices? Various Other Specifications, Standards, and related Requirements 16
S 5 Zu - Japanese concept Quality Tools, Improvement and Analysis 14
O Training of Japanese Manufacturing Tools Lean in Manufacturing and Service Industries 6
T How to handle medical product changes? - Japanese market ISO 13485:2016 - Medical Device Quality Management Systems 7
Stijloor Training Materials: "Working With Japanese Colleagues" Training - Internal, External, Online and Distance Learning 1
I J-STD-002 - Japanese Standard - Solderability Tests - Where to find Various Other Specifications, Standards, and related Requirements 6
Govind What is a Proof Reading Ratio? Japanese Customer Questionnaire General Measurement Device and Calibration Topics 10
T ISO 10993 Tests of End Product vs. Test of Material - Japanese Requirements ISO 13485:2016 - Medical Device Quality Management Systems 6
S Japanese companies don?t adopt SIX SIGMA / ISO - Still they are leading in Quality Misc. Quality Assurance and Business Systems Related Topics 66
Marc The Japanese Foundation of Quality Philosophy, Gurus, Innovation and Evolution 41
F ISO13485:2003 vs. the Japanese PAL Ordinance No. 169 - Seeking Gap Analysis ISO 13485:2016 - Medical Device Quality Management Systems 1
Q If iso 9001 registration is a mandatory, would... Japanese auto manufacturers pass? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
T Definition Gemba is a japanese term for place (Where the action is) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 12
H Japanese Regulations for Medical Devices - Three Questions ISO 13485:2016 - Medical Device Quality Management Systems 6
S What are the Japanese Big 3 Requirements - Nissan, Toyota, Honda Customer and Company Specific Requirements 16
W Japanese Market - Any special requirements (regulatory or quality)? ISO 13485:2016 - Medical Device Quality Management Systems 3
Y New Japanese EMC/electrical safety standards - Additional product testing required? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
P IQ, OQ, PQ protocol, and report templates for Distributed Control Systems in Pharmaceutical Manufacturing Systems. Qualification and Validation (including 21 CFR Part 11) 0
E Best way to keep up with pharmaceutical quality knowledge and current affairs Service Industry Specific Topics 1
E Non-GMP examples in Pharmaceutical industry Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
D Clothes changing in pharmaceutical factory Manufacturing and Related Processes 8
A Reduced Testing of Pharmaceutical Raw Materials Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
H Communication plan according to ISO9001 - Pharmaceutical field Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
P ISO 5 Pharmaceutical clean room design Process Maps, Process Mapping and Turtle Diagrams 2
A Any recommendation for ASQ's CPGP (Pharmaceutical GMP Professional) Certification exam questions? ASQ - American Society for Quality 2
A Pharmaceutical Manufacturer's obligations - Laboratory Test instruments General Measurement Device and Calibration Topics 0
S Pharmaceutical and Healthcare Sciences Society ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 5
S Any suggestions for ASQ CPGP (Certified Pharmaceutical GMP Professional) exam prep? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 4
C Revision of Japan's Pharmaceutical Affairs Law (PAL) in 2014 Japan Medical Device Regulations 10
Ajit Basrur FDA Loosens Pharmaceutical Regulations on 13 Companies Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1

Similar threads

Top Bottom