1. A clearance certificate shall be obtained from the EDE for each batch of certain vital products that require compliance with safety, quality and efficacy standards, either after they are manufactured in the State or for the purposes of obtaining the EDE approval to import and distribute them. 2. The Executive Regulations of this Decree-Law shall specify the types of other Medical Products subject to Clause (1) of this Article, any exceptions thereto, and the requirements that shall be met to obtain the certificate.
Interpretation and application must be checked against the official text and current version.