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Overview of product Registration & Evaluation

 

Kindly note that the policy on regulation of medical laboratory diagnostics shall soon be on posted on our website and it shall outline the process extensively.

The following are the key notable points to be addressed:

First, a manufacturer shall be exclusively responsible for any medical laboratory device or diagnostic being brought into the country. The manufacturer shall then inform the Board of any local authorized representative or local distributor(s).

Whereby the Manufacturer is defined as any natural or legal person with responsibility for design and/or manufacture of an IVD with the intention of making the IVD available for use, under his name; whether or not such an IVD is designed and/or manufactured by that person himself or on his behalf by another person(s).

An In Vitro Diagnostic (IVD) is a reagent, apparatus, an instrument or machine, whether used alone or in combination, intended by the manufacturer (including laboratory developed tests)for the in-vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes.

The Application form will be made available online. Meanwhile all Manufacturers will be required to submit a dossier which shall consist of the following information:

1)     Device Description;

2)     Design verification and validation – pre-clinical studies and clinical evidence;

3)     Manufacturer’s information- Quality assurance and good manufacturing process certifications;

4)     Demonstration of conformity to essential principles of safety and performance;

5)     Risk analysis and environmental studies;

6)     Labeling; and

7)     Information on commercial history and post market information.

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