One registration per group
The Manual for Health Registration of Medical Devices (RM 0010/2006) establishes that devices are registered by group: one health registration for each group, according to the grouping in its Annex 2.
Who is the technical manager
The manual accepts as regent or technical manager professionals from different fields, including pharmacists, pharmaceutical chemists, physicians and biomedical, industrial, electronic, mechanical or chemical engineers.
Renewal
When a registration reaches its expiry, the new application is processed as a renewal, and the manual regulates how and when to do it (item 2.3.3). We tell you the right moment for your case.
The company must also be licensed
The importer or laboratory must hold a valid operating authorization. There are specific opening forms for medical device importers and laboratories.
Sources
- RM-0010-2006: Manual for Health Registration of Medical Devices (chapter II and Annex 2)
- Opening forms FORM-086 and FORM-096
General information. Requirements are subject to the current AGEMED regulations.