The demand for monkeypox detection reagents surges. How to apply for overseas registration?

On July 23, the World Health Organization listed monkeypox as a "public health emergency of international concern". "Public health emergencies of international concern" is the highest level alert issued by WHO.

Since this year, 72 member countries in all six regions of WHO have reported more than 15000 confirmed cases of monkeypox.

Detection reagents also play a very important role in the prevention and control of monkeypox. It can be predicted that the demand for monkeypox detection reagents in the subsequent global market will increase significantly.

Can we still apply for European registration?

During the effective operation of IVDD, monkeypox detection reagents are classified as Class Other, i.e. self declared products by competent authority, and one of the procedures that must be followed before they are put on the market is the product registration of the competent authority.

Before May 26, 2022, we have successfully assisted 50 manufacturers to complete the European (Netherlands and Germany) registration of monkeypox detection products.

However, with the official end of the EU IVDD transition period on May 26, 2022, monkeypox detection reagents under EU regulations can no longer apply for product registration in accordance with the IVDD directive. Under the IVDR regulation, this product belongs to the product that needs the conformity assessment of the notified body, and cannot be directly CE registered.

Missed the European registration, what opportunities are there?

If you miss the registration as manufacturer in Europe, are there other opportunities? In addition to the European and American markets, there are also many important national and regional markets in the Middle East, South America, Asia and so on. These countries and regions usually need the manufacturers to complete local registration through CFS free sales certificate.

We can provide you with UK MHRA registration and apply for CFS free sale certificate based on UK registration. CFS issued by MHRA in the UK is widely recognized all over the world, so that when products enter the UK market, they can also enter many other countries and regions that accept CFS.

How to register in the UK?

According to the classification rules of UK medical devices regulations 2002, monkeypox detection reagents used for professional testing belong to other category.

Its compliance procedure is the declaration of compliance, including the preparation of technical documents, the signing of the declaration of compliance, the appointment of the UK Representative (UKRP) and the completion of registration with the competent authority.

Sungo is the first UKRP in the world to successfully submit MHRA registration of monkeypox reagent. So far, Sungo has completed the MHRA registration declaration for several monkeypox reagent manufacturers in China, and the products include nucleic acid reagents, antigen and antibody reagents.

Please contact us if you need