In the rush to introduce a new product, many companies give little thought to the appointment of their in-country regulatory representative and appoint a distributor to fulfill this important role. This can be a costly mistake.
Considering appointing a distributor as your in-country representative? Read this first.
- In markets such as Japan, Mexico and Brazil, the in-country regulatory representative controls the device approval and/or device registration. If you appoint a distributor to this role instead of an independent regulatory representative, switching distributors becomes extremely difficult and may require starting the device approval process all over again if your distributor is not willing to cooperate. This can be extremely expensive as you would not be able to sell in the market until re-registration is completed. You would also be required to pay a new registration fee.
- In many markets your technical documentation, labeling, manuals and other information must include your in-country representative's name and address. If you elect to use a distributor and then decide to switch distributors, you will need to reprint labels, manuals, and deal with the issue of products already in the marketplace with that distributor's name on them. Plus, distributors do not like to see other distributors names on your labeling.
- Most distributors are not aware of the role of an in-country representative and the mandatory responsibilities that come with it and often elect to take on this responsibility to maintain control over your device on the market from a commercial point of view.
- A conflict of interest may occur in the event of recall and/or incident reporting between you (the manufacturer) and the distributor. If the regulatory authorities question an incident or a non-compliance that occurred in the distribution system, will your distributor defend their company or yours?
- The distributor is focused on sales and marketing, not on regulatory affairs. They may not keep you up-to-date on regulatory changes in the market and provide timely warnings when changes affect your devices.
Emergo is an independent in-country regulatory representative for 2,000+ medical device companies worldwide.
Emergo can act as your representative in ALL of the following markets:
Australia TGA Sponsor
Brazil ANVISA Registration Holder
Europe Authorized Representative (EC REP)
Israel Registration Holder
India Authorized Agent
Japan Designated Marketing Authorization Holder (D-MAH)
Mexico COFEPRIS Registration Holder
New Zealand Sponsor
Saudi Arabia Authorized Representative
Singapore Authorized Representative
South Korea License Holder
United States FDA US Agent
Contact us for more information on independent in-country representation services for any of the markets listed above.