USA
Allgemein
Der erste Schritt in den US-Markt besteht darin eine "Establishment registration" zu erlangen, die eine jährliche Aktualisierung und die Zahlung von Jahresgebühren nach sich zieht.
Klassifizierung
Die Produkte können mit Hilfe der FDA Datenbank oder den 21CFR als Klasse 1, 2, 3 klassifiziert werden.
Produktregistrierung
Products not being exempted from pre-market notifications as per the 21 CFR either require:
- 510(k) pre-market notification
- or PMA pre-market approval
Qualitäts-Management System
Every organisation not being exempted from GMP need to implement a GMP system based on 21CFR820 that can be subject to Quality system inspection based on MDSAP or FDA inspections.
Besonderheiten
The UDI needs to be affixed to the products and all product need to be registered in the GUDID database.
Kanada
Allgemein
Der Hersteller kann die Registrierung selber beantragen, nachfolgend spielt der Kanadische Importeur eine wichtige Rolle in der Kommunikation mit Health Canada.
Klassifizierung
The Canadian Medical device regulations as set out in SOR 98-282 include four classes:
Class I, II, III, IV
Produktregistrierung
Product registration is required for classes II, III, IV. For class II the application form plus proof of quality system is mostly sufficient, for class III and IV technical documentation based on the IMDRF nIVD(MA)ToC and review by Health Canada is mandatory.
Qualitäts-Management System
For all Class II, III, and IV the implementation of a QMS is obligatory and needs to be audited under the MDSAP program.
Besonderheiten
The Canadian importer needs to report incidents in parallel to the manufacturer.
Mexiko
Allgemein
Mexico tries to simplify the registration process e.g. for products already holding a valid registration in USA, Canada or Japan.
Klassifizierung
Under the Mexican legislations the products are classified as Class I (bajo riesgo), Class I, II, III based on a set of rules.
Produktregistrierung
For the product registration the importer is required to submit a set of product documentation based on the approval route that can be the simplified "Equivalencia" or the "normal" procedure or the procedure using a "third party review" upfront.
Qualitäts-Management System
Foreign manufacturers holding a valid quality system certificate for medical devices do not need to be audited by the Mexican COFEPRIS.
Besonderheiten
The Mexican registration number needs to be affixed to the device prior to entering the market.
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| Content of this website was last updated 2019-10-22 |