New Medical Device and IVD Registration Rules - Pakistan

#1
Pakistan?s Drugs Regulatory Authority has issued new medical device and in vitro diagnostic (IVD) regulatory requirements, the Medical Devices Rules 2015, which have gone into effect.

The new regulations include requirements for conformity assessments, quality management systems, classification guidelines, authorized representation for foreign manufacturers and related registration steps. Publication of the new rules follows legislation established in late 2012 to formally regulate medical devices and pharmaceuticals in Pakistan. Refer the attachment.

See more at: http://www.raps.org/Regulatory-Focu...h.wDNJS3xe.mjjo#sthash.wDNJS3xe.ZClHYAgD.dpuf
.
 

Attachments

Elsmar Forum Sponsor

Mallappa

Involved In Discussions
#2
Hi Ajith,

I have gone through the Pakistan's new regulations and there is no mention of "who holds Registration/Enlistment Certificate in Pakistan"?

I really appreciate if you could help me with the answer.
 

Mallappa

Involved In Discussions
#4

WAQAR-QMS

Medical Devices Expert
#6
It is just the one rule, which cover IVD and rest requirements including pharma also.
If any specific help needed, do let me know i can check with authorities.
 
Thread starter Similar threads Forum Replies Date
R How to find the proper the fieids of IVD distributers and develop the medical device markets in Thailand? Manufacturing and Related Processes 0
M Informational TGA – European implementation of Medical Device and IVD Regulations – Implications for Australia Medical Device and FDA Regulations and Standards News 0
P Usability/human factors engineering requirement (standard) for IVD medical device Other Medical Device Related Standards 2
R Medical Device (IVD) - Selling RUO to Customers EU Medical Device Regulations 2
C ISO 13485 Medical Device File requirements for IVD ISO 13485:2016 - Medical Device Quality Management Systems 1
T Is an EEG (Electroencephalogram) an IVD or a Medical Device? Other US Medical Device Regulations 14
F IVD/Medical Device Registration (with MHRA DORS account in the UK) EU Medical Device Regulations 3
F CE and FDA Mark on same IVD/Medical Device Label EU Medical Device Regulations 12
N New MDR EU Medical Device/IVD Regulations - Definition of Importer EU Medical Device Regulations 1
F CE Marking Algorithm for an IVD use only Medical Device EU Medical Device Regulations 7
E Republic Of Georgia Medical Device Regulations for IVD Other Medical Device Regulations World-Wide 6
R Shipping Stability for Class III IVD (Non Sterile) Medical Device Other Medical Device Related Standards 7
J FDA Compliant Quality System for Virtual Manufacturing (IVD Medical Device)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
W IVD Medical Device Registration in Indonesia Other Medical Device Regulations World-Wide 2
E IVD Medical Device Product Registration in Myanmar Other Medical Device Regulations World-Wide 3
E IVD Medical Device Product Registration in Indonesia Other Medical Device Regulations World-Wide 2
K South Korea IVD Medical Device Classifications Other Medical Device Regulations World-Wide 13
P IVD Medical Device Authorized Representative Requirements in EU EU Medical Device Regulations 6
bio_subbu GHTF issues revised document "Definitions of ?Medical Device? and ?IVD? Other Medical Device Regulations World-Wide 1
S Medical Device/IVD Manufacturer Supplier Requirements - Compliant to ISO 13485?? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
G IVD (In Vitro Diagnostic) MDD (Medical Device Directive) Borderline Issues EU Medical Device Regulations 3
L Canadian Medical Device and IVD (In Vitro Diagnostic) Requirements US Food and Drug Administration (FDA) 3
S Single Medical Device Warranty card for both RUO and IVD!! ISO 13485:2016 - Medical Device Quality Management Systems 1
W Requirements for using Open Source Software in Medical Devices - IVD Medical Device IEC 62304 - Medical Device Software Life Cycle Processes 10
M IEC 60601 vs. IEC 61010 - CE Mark for our IVD medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
C Regulatory Affairs in a start-up medical device company Career and Occupation Discussions 1
somashekar Medical device file Vs Role undertaken by the organization ISO 13485:2016 - Medical Device Quality Management Systems 1
M Medical Device Label - Language EU Medical Device Regulations 2
D MDR: Active medical device or not? Medical Information Technology, Medical Software and Health Informatics 4
H Mapping QMS+business processes in a medical device with class I and IIa+b Process Maps, Process Mapping and Turtle Diagrams 3
Aliken Registration veterinary medical device (laser) requirements Medical Device and FDA Regulations and Standards News 0
T Classification Accessory Software medical device EU Medical Device Regulations 4
J CGMP Medical device slide deck Manufacturing and Related Processes 1
M Notification Requirements for Medical Device Raw Materials 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
I Madagascar medical device regulation Other Medical Device Regulations World-Wide 0
R Steam sterilizer medical device reclassification EU Medical Device Regulations 3
G Software Medical Device Classification EU Medical Device Regulations 7
J Robotic arm with a camera, active medical device? EU Medical Device Regulations 12
D Out of specification procedure for Medical device manufacturing Manufacturing and Related Processes 7
K Medical Device Shipping Container Label Manufacturing and Related Processes 3
S Is Amalgam Separator considered a Medical Device in US and EU? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
K New to Medical Device QMS and would like advice ISO 13485:2016 - Medical Device Quality Management Systems 9
C Medical device label storage conditions EU Medical Device Regulations 11
W Regulation of medical device in Hong Kong Other Medical Device Regulations World-Wide 1
M Inspiring leaders in the medical device industry ISO 13485:2016 - Medical Device Quality Management Systems 5
A Layered Process Audits for Medical Device Manufacturing? ISO 13485:2016 - Medical Device Quality Management Systems 3
P Transferring medical data from a device (Sec 201(h)): regulatory implications US Medical Device Regulations 3
R Is "SAFE" permitted in class 1 medical device marketing claims? US Medical Device Regulations 1
T Determining FIPS 140-2 compliance in a medical device Medical Information Technology, Medical Software and Health Informatics 2
I Importing medical device into Canada for exclusive distribution in the U.S. Medical Device and FDA Regulations and Standards News 0

Similar threads

Top Bottom