Argentina (ENACOM) - Resolution 863 and Standard ENACOM-Q2-60.15 V19.1 For Medical Device
Ente Nacional de Comunicaciones (ENACOM) has released Resolution 863 (replacing 4665-E/2017) along with a new technical standard ENACOM-Q2-60.15 V19.1 regarding the approval of medical devices in Argentina.
- The allocation of the 430-440MHz band for Wireless Endoscopy Medical Capsules and associated receivers
- An exemption to test and register passive implantable medical devices that require to be powered by a reader device for operation
The following is a summary of the current allocated frequencies and associated field strengths:
- 9-315 kHz: 30 dBμA/m @ 10m in EPZA
- 30-37.5 MHz: 150,000 μV/m @ 3 m in EPZA
- 401-406 MHz: 18,260 μV/m @ 3 m in EPZA
- 430-440 MHz: 1,480 μV/m @ 3 m en EPZA
Regarding technical standard ENACOM-Q2-60.15 V19.1, currently no labs have accreditation and therefore local testing is not required. Manufacturers are currently using a Declaration of Conformity to prove compliance to the standard. Once local labs obtain accreditation, we expect testing to become mandatory.