USA
General
First step into the US market is to generate the Establishment registration requiring annual updates and subsequent payment of fees.
Classification
Products can be classified as class 1, 2, 3 based on the FDA product classification database or the 21 CFR.
Product Registration
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
Quality 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.
Specifics
The UDI needs to be affixed to the products and all product need to be registered in the GUDID database.
Canada
General
The Canadian Importer plays an important role in the communication with the Canadian Authorities.
Classification
The Canadian Medical device regulations as set out in SOR 98-282 include four classes:
Class I, II, III, IV
Product Registration
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.
Quality System
For all Class II, III, and IV the implementation of a QMS is obligatory and needs to be audited under the MDSAP program.
Specifics
The Canadian importer needs to report incidents in parallel to the manufacturer.
Mexico
General
Mexico tries to simplify the registration process e.g. for products already holding a valid registration in USA, Canada or Japan.
Classification
Under the Mexican legislations the products are classified as Class I (bajo riesgo), Class I, II, III based on a set of rules.
Registration
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.
Quality System
Foreign manufacturers holding a valid quality system certificate for medical devices do not need to be audited by the Mexican COFEPRIS.
Specifics
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 |