Post Market Resource Center (PMRC)

Submitted by admin on Thu, 02/25/2021 - 03:13

The Post Market Resource Center (PMRC) is a tool developed by Work Group 4 of AHWP/GHWP to provide a “one-stop” location for Regulatory Authorities (RAs) and the Medical Device Industry (Industry) to access to post-market regulations and reporting information easily across the world. It provides up-to-date access link to the regulatory requirements and guidance of those RAs on adverse event reporting and handling of field safety corrective actions. 

The links are in the Final Document 'Post Market Resource Center'. For easier access to the PMRC, the hyperlinks are presented in the tables below:

AHWP/GHWP

Adverse Event Reporting Field Safety Corrective Information/ Recall

Country/Economy

Reporting System & Guidance Document Reporting Safety Alert Information Guidance Document Reporting

China

Guidance download page (Chinese) Login access page (Chinese) Recall notices (Chinese) Recall procedure (Chinese) Form download page (Chinese)

Chinese Taipei

1. Login access page (Chinese)

2. System (Chinese)

3. Procedure for Reporting Severe Adverse Reactions to Medicines  (Chinese)

Form download page (Chinese)

1. Safety monitoring list (Chinese)

2. Safety alerts (Chinese)

Guidance for MD good vigilance practice (Chinese)

1. Login access reporting page (Chinese)

2. Format (Chinese)

Hong Kong SAR, China

1. System

2. GN-03 Guidance Notes for Adverse Incident Reporting by Local Responsible Persons

Form download page

1. Summary of Safety alerts

2. Important Safety Alerts

CoP of Local Responsible Persons (S3.7) CoP of Local Responsible Persons (S3.7)

Kingdom of

Saudi Arabia

1. Reporting home page

2. NCMDR FAQ

1. HCP or public online reporting

2. Supplier login reporting

3. Registration Page

FSNs/ Recalls NCMDR FAQ Supplier login reporting

Malaysia

1. Web guidance

2. Guidance Document

Form download page  Recalls & safety alerts

1. Web guidance (Recall)

2. Web guidance (Field corrective action)

1. Form download (Recall)

2. Form download (Field safety notice)

3. Form download (Field corrective action)

Republic of Korea

1. Regulation

2. Introduction to safety information  (Korean)

1. Form

2. Medical Device Act Enforcement Regulation

Recalls (Korean) Guidance Document Links (Korean)

1. Recall Planning and termination Reporting

2. (Form) Medical Device Act Enforcement Regulation

Singapore

1. Reporting System

2. GN-05 Guidance on the Reporting of AEs for Medical Devices download

1. AE Form download page

2. E-form

1. Announcement

2. Subscription to updates

1. GN-04 Guidance on medical device recall

2. GN-10 Guidance on medical device FSCA download

1. MDRR1 Form: FSCA Notification/Preliminary Report Form

2. MDRR2 Form: FSCA Follow-Up or Final Report Form

3. MDRR3 report form

Thailand

1. Reporting Manual for Nursing Home

2. Reporting Manual for entrepreneur

Website link NA Website link Medical Device Problem Reporting

Indonesia

Regulation Online (E-watch) NA NA NA

 

Former GHTF

Adverse Event Reporting Field Safety Corrective Information/ Recall

Country/Economy

Reporting System & Guidance Document Reporting Safety Alert Information Guidance Document Reporting

Australia

1. Medical device incident reporting (MDIR) user guide 2013

2. Reporting adverse events FAQ

1. Reporting page

(online forms available in the Medical Device Incident Reporting (MDIR) system requiring login access)

2. Reporting page (user)

1. Current year  alerts

2. All alerts

3. Australian recall actions

Uniform recall procedure for therapeutic goods (URPTG) Reporting page

Canada

Adverse Reaction and Medical Device Problem Reporting Online reporting link and reporting form download page Recalls & alerts Guide to Recall of Medical Devices Reporting form download page

Japan

Post-marketing Safety Measures Reporting form download page (Japanese)

1. Safety Information regarding medical devices

2. Notification

3. Medical Device Recalls (Japanese)

Post-marketing Safety Measures NA

US

1. Mandatory Reporting Requirements

2. Medical Device Reporting

Electronic Medical Device Reporting (eMDR) Medical Device Safety Information Recalls, Correctionis and Removals (Devices) Medical Device Reporting (MDR)

EU

-France

Incident Reporting (French) Report Form

1. Safety alerts (French)

2. Recalls (French)

3. Latest Information published in English (scroll to the bottom of the page)

NA NA

EU

-Germany

Vigilance System SAE Report Form NA Vigilance System Field Safety Corrective Actions

Switzerland

Reporting incident & FSCAs

1. Users & Operators

2. Manufacturers & Placers on the market

NA Reporting incident & FSCAs

1.Users & Operators

2. Manufacturers & Placers on the market

UK

Reporting adverse incidents and corrective actions

1. Medical device adverse incident (public)

2. Manufacturer’s online Reporting Envoironement

Alerts and recalls for drugs and medical devices Reporting adverse incidents and corrective actions Login access online reporting page