Guidance for Medical Device Registration in Med Dev Regulations World-Wide

[Marcelo]

I've just noted that we should have a general thread with guidance from regulators on medical device registration around the world. It's important to note that those are usually only in the language of the country of origin.

 

[Marcelo]

ANVISA

Several registration guidances for different types of medical devices, they are from some years ago, but most of the information is still the same.

Manual para regulariza??o de produtos para diagn?stico in vitro na ANVISA (Manual for regularization of IVD product at Anvisa)

Manual para registro de implantes ortop?dicos na ANVISA (Manual for registration of orthopedic implants at ANVISA)

Manual para registro de equipamentos m?dicos na ANVISA (Manual for registration of medical equipment at ANVISA)

materials Manual de registro e cadastramento de materiais de uso em sa?de (Manual for “registro” and “cadastro” of materials used in healthcare)[/URL]

 

[Marcelo]

Chile

See below.

 

[Marcelo]

Venezuela

The guidance are related to how to fill the forms.

INSTRUCTIVO PARA EL LLENADO DEL FORMULARIO DE SOLICITUD DE INCLUSI?N DE EMPRESA IMPORTADORA Y/O DISTRIBUIDORA DE MATERIALES Y EQUIPOS DE SALUD (INSTRUCTIONS FOR COMPLETING THE APPLICATION FOR INCLUSION OF IMPORTING COMPANY AND / OR DISTRIBUTOR OF HEALTH MATERIALS AND EQUIPMENT)

INSTRUCTIVO PARA EL LLENADO DE LA SOLICITUD DE PERMISO DE IMPORTACI?N DE MATERIALES Y EQUIPOS DE SALUD (INSTRUCTIONS FOR FILLING THE IMPORT PERMIT APPLICATION OF HEALTH MATERIALS AND EQUIPMENT)

INSTRUCTIVO PARA EL LLENADO DEL FORMULARIO DE SOLICITUD PARA REGISTRO SANITARIO DE EMPRESA DE MATERIALES Y EQUIPOS DE SALUD (INSTRUCTIONS FOR COMPLETING THE APPLICATION FORM FOR HEALTH RECORD COMPANY OF HEALTH MATERIALS AND EQUIPMENT

INSTRUCTIVO PARA EL LLENADO DE LA SOLICITUD DE REGISTRO SANITARIO O RENOVACI?N DE MATERIALES Y EQUIPOS DE SALUD (INSTRUCTIONS FOR FILLING THE APPLICATION FOR REGISTRATION OR RENEWAL OF HEALTH MATERIALS AND EQUIPMENT)

 

[Marcelo]

Uruguay

MANUAL DE PROCEDIMIENTOS - REGISTRO DE PRODUCTO - DISPOSITIVOS TERAP?UTICOS - REACTIVOS DE DIAGN?STICO - EQUIPOS M?DICOS (PROCEDURES MANUAL - PRODUCT REGISTRATION - THERAPEUTIC DEVICES - DIAGNOSTIC REAGENTS - MEDICAL EQUIPMENT)

 

[pkost]

Europe:
MEDDEV documents issued by EC

Team NB documents issued by notified bodies

Central management committee decisions

Harmonised standards (EC)

Borderline devices

 

[pkost]

Europe (UK)

Compentent authority: MHRA

Software

Classification

Borderlines

Clinical Trials

Registraton of medical devices (Class I, Is/m, Procedure packs, custom devices)

 

[Ronen E]

Australia

Australian regulatory guidelines for medical devices (ARGMD)

 

[Ronen E]

USA

Start here

 

[xgg810116]

India CDSCO-Medical Devices and Diagnsotics

http://www.cdsco.nic.in/forms/list.aspx?lid=1580&Id=1