Pakistan Medical Device Regulations

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Medical Devices – Drug Regulatory Authority of Pakistan

https://www.dra.gov.pk/publications/guidelines/medical-devices/

Last Updated on January 4, 2023. Following guidelines are intended to help the industry and other applicants to meet the regulatory requirements related to the Medical Devices. 1. Distribution of Medical Devices. Guidelines on Good Distribution Practices of …

Risk Classification – Drug Regulatory Authority of Pakistan

https://www.dra.gov.pk/therapeutic-goods/medical-devices/risk-classification/

Last Updated on February 22, 2022. Medical devices are classified into four classes: Class A, Class B, Class C and Class D. It is a risk-based classification. The …

Drug Regulatory Authority of Pakistan – Ministry of …

https://www.dra.gov.pk/

Ministry of National Health Services, Regulations & Coordination. ... Rules 1976 and the Medical Device Rules, 2017 February 16, 2023; Invitation to bid (Supply of …

TO BE PUBLISHED IN PART-II OF THE EXTRA …

https://www.dra.gov.pk/wp-content/uploads/2022/02/FFMedicalDevicesRules2017Notifiedon16-01-2018-1.pdf

Pakistan, with the approval of the Federal Government, is pleased to make the following rules, ... (IMDRF) working for harmonization of medical devices, regulation in Asian and …

Pakistan Medical Device Registration - DRAP Approval

https://arazygroup.com/medical-device-registration-and-approval-in-pakistan/

LOCAL FEES: Class A – USD $35. Class B – USD $175. Class C – USD $350. Class D – USD $350. LICENSE VALIDITY: 5 years. LICENSE TRANSFER: …

Pakistan Medical Device Regulations | RegDesk

https://www.regdesk.co/resource-library/pakistan/

Registration Cost: USD $1440-$3634 depending on type of device and. Local Testing. Not required. Clinical Studies. Required. Post Market Surveillance. The manufacturer must …

Medical Devices Establishment Licenses – Drug Regulatory …

https://www.dra.gov.pk/therapeutic-goods/licensing-and-inspections/medical-devices-establishment-licenses/

There are two types of establishment licenses of medical device. Sr. Types. 1. Establishment License to manufacture medical devices, components or accessories. …

Pakistan - Healthcare and Medical Equipment

https://www.trade.gov/country-commercial-guides/pakistan-healthcare-and-medical-equipment

According to a well thought of research study, the medical devices market in Pakistan is estimated at $500 - $600 million with an estimated growth rate of 15 percent …

Pakistani government publishes new medical device and IVD …

https://www.massdevice.com/pakistani-government-publishes-new-medical-device-and-ivd-registration-rules/

By Stewart Eisenhart, Emergo Group Pakistan's Drugs Regulatory Authority has issued new medical device and in vitrodiagnostic (IVD) regulatory requirements, the …

New Medical Device and IVD Registration Rules - Pakistan

https://elsmar.com/elsmarqualityforum/threads/new-medical-device-and-ivd-registration-rules-pakistan.67124/

Admin. Mar 28, 2015. #1. Pakistan?s Drugs Regulatory Authority has issued new medical device and in vitro diagnostic (IVD) regulatory requirements, the Medical …

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