A Common Registration File

To obtain pre-market approval to register an IVD Medical Device manufacturers or their agent/distributor submit a dossier of evidence to the National Regulatory Agency (NRA)  in each country where they wish to market the product. Dossiers are a complex set of documents that describe the product and intended use, product design, manufacturing and verification and validation data. For products classified as high risk to individual or public health clinical performance data may also be required. Currently dossiers vary in format and in the evidence required and manufacturers have to prepare a different dossier for each country which is a lengthy and costly process.

Harmonisation of submission dossier requirements and adoption of a Common Registration File will


Reduce the cost to manufacturers of registering a product, a cost that would ultimately be passed to the consumers of the test.

Reduce delays in test registration.

Reduce disincentives to marketing in small economies.

Facilitate harmonised approval of diagnostic devices reducing the burden on NRA and cost of national regulatory approval.



PAHWP is working with the IVD sub group of the Asian Harmonization Working Party to develop a Common Registration File using POC tests for CD4, viral load and early infant diagnosis as examples.
©2016 Pan African Harmonisation Working Party
Improving Access to Affordable Diagnostics