Distributor programme

Bring a CE Class IIa skin closure device into your market

BI-FIX is a non-invasive surgical incision closure set with a Class IIa CE certificate, published clinical data and nine sizes covering 2 cm to 24 cm. We are looking for distributors in selected markets who already serve hospitals or surgical departments.

Apply now Product and clinical data

What you get

Market authorisation

A Letter of Authorisation naming your company as the representative for your market, issued by the manufacturer, so you can register the product locally.

The complete file set

EU Declaration of Conformity, notified body certificate, ISO 13485, certificate of free sale, clinical evaluation, sterilisation and ageing reports, labels and instructions for use.

Samples before you commit

Free samples in several sizes so your surgical team can evaluate the device on real incisions before you place an order.

Registration support

We answer your authority's questions directly, and we work with your regulatory consultant through the submission.

Sales and training material

Product images, a procedure video, a clinical data sheet and an online training session for your sales team and your hospitals.

Protected territory

Where you commit to volume, we agree a protected or exclusive territory for a defined period. We do not undercut our distributors.

What we look for

We would rather have a few committed distributors than many inactive ones, so we are straightforward about what makes a good fit.

Good fit

You already sell surgical consumables, wound care or hospital supplies
You supply at least three hospitals or a hospital group
You can handle product registration, or you work with someone who does
You can commit to a volume plan for the first twelve months

Not a fit

Retail-only e-commerce sellers
Single clinics buying individual units
Brokers without a distribution licence or a hospital network
Requesting exclusivity without any volume commitment

Tell us about your market

Send us these five things and we will reply within one working day with availability, indicative pricing and the registration route for your country.

What to include

Company name and website
The country or countries you cover
Which hospitals or departments you supply
Whether you hold a medical device distribution licence
Whether you can carry out local registration

Send it directly

Email sales@miloracare.com with the subject line "BI-FIX distributor application".

Or message us on WhatsApp: +86 139 1616 9100

One-page form available on request. We answer in English, and we can arrange a short call with our technical specialist if you want to discuss clinical questions.