Post Market Resource Center (PMRC)

The Post Market Resource Center (PMRC) is a tool developed by Work Group 4 of 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:

GHWP/GHWP	Adverse Event Reporting		Field Safety Corrective Information/ Recall
Country/Economy	Reporting System & Guidance Document	Reporting	Safety Alert Information	Guidance Document	Reporting
People's Republic of China	Guidance page (Chinese)	Login access page (Chinese)	Recall notices (Chinese)	Recall p rocedure (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) 4. Guidance on reporting adverse event (Chinese)	Form download page (Chinese)	1. Safety monitoring list (Chinese) 2. Safety alerts (Chinese)	1. Regulations for Medical Device Recalls 2. Guidance on recall (Chinese)	1. Login access reporting page (Chinese) 2. Form (Chinese)
Hong Kong SAR, China	1. System 2. GN-03 Guidance Notes for Adverse Incident Reporting by Local Responsible Persons	Medical Device Adverse Event Report Form - for Local Responsible Persons and Medical Device Users	Summary of Safety alerts	Code of Practice for Local Responsible Persons (S3.7)	Code of Practice for 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 alert s	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 3. Reporting via Online Safety, Compliance Application and Registration (OSCAR) System	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	Technical Guidelines for Reporting KTD Medical Devices (Indonesia)	KTD Report Form (Indonesia)	Product recalled by the Ministry of Health (Indonesian)	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- for sponsor/ manufacturer) 2. Reporting page (user)	1. Current year alerts 2. All alerts 3. Australian recall actions	Uniform recall procedure for therapeutic goods (URPTG)	Reporting page (online forms available in the Medical Device Incident Reporting (MDIR) system requiring login access- for sponsor/ manufacturer)
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. Medical Device Recalls (Japanese)	Post-marketing Safety Measures	NA
US	Mandatory Reporting Requirements	Report form	Medical Device Safety Information	Recalls, Correctionis and Removals (Devices)	Report form
EU -France	Reporting an incident resulting from the use of a medical device (French)	Adverse health event reporting portal (Frence)	1. Safety alerts (French) 2. Recalls (French)	Reporting FSCA	FSCA Reports
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