Authorised Representation, Sponsorship & Distribution Management
In most jurisdictions, regulatory agencies insist on product licenses being held by a legal entity domiciled within the market – typically a registered company. The local entity is usually known as a Market Authorisation Holder, Authorized Representative or Sponsor. It takes responsibility for the product in the market, files regulatory submissions and conducts communications with the regulator on behalf of the manufacturer.
Brandwood Biomedical offers market representative and Agency services for all your Device Registration needs. This is more than an administrative solution – we take care of the entire regulatory process and provide complete professional management of ongoing compliance so that you can focus on building your business.
We are able to support your regulatory filings through our own offices and wholly owned operations in Australia (TGA) New Zealand (Medsafe) and China (CFDA). We can also support most markets in ASEAN, Japan (PMDA) and Korea (MFDS) through local trusted partners.
Why shouldn’t I just use my distributor as my Authorised Representative?
The selection of representative/license holder is critical to the orderly continuation of supply. Use of the distributor as representative is not recommended because:
- Distributors are focused on sales and marketing and most don’t have the regulatory skills and capacity to manage product compliance
- If a distribution contract is terminated, then the original distributor can cause disruption to continuity of supply and delay the transfer of sponsorship to the new entity. This may even force the supplier to obtain a completely new regulatory approval with substantial interruption to business.
As a specialist market representative Brandwood Biomedical takes responsibility for the regulatory compliance and provides the interface with regulatory authorities. This provides the peace of mind of professional management of regulatory compliance, while distribution arrangements can be independently structured for maximum commercial benefit.
Need assistance with your Global Medical Device and IVD Regulatory Services?
We can help you with developing your evaluation strategy, dealing with test laboratories and preparation of expert reports. Contact us to discuss your needs and how we can help. You can drop us an email [email protected] or call 1 888-271-5063 (US toll free) ♦ 400-842 7017 (Beijing – toll free) ♦ +61 2 9906 2984 (Sydney)