Technical Standard for Medical Device Approval Released

The Ente Nacional de Comunicaciones (ENACOM) of Argentina released Resolution 863 with a new technical standard regarding the approval of medical devices.

The new technical standard ENACOM-Q2-60.15 V19.1 does not require local testing because no labs have accreditation yet. Once local labs obtain accreditation, testing may become mandatory. Right now, manufacturers can use a DoC to prove compliance.

The new Resolution 863 has the following updates:

  • The 430-440MHz band is now allocated for Wireless Endoscopy Medical Capsules and associated receivers
  • Passive implantable medical devices that are powered by a reader device for operation are exempt to testing and registration

The current allocated frequencies and field strengths are as follows:

  • 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

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