ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯏꯃꯞꯂꯥꯟꯇ ꯁꯞꯂꯥꯏꯌꯔꯁꯤꯡꯕꯨ ꯀꯔꯝꯅꯥ ꯚꯦꯠ ꯇꯧꯒꯅꯤ꯫

ꯊꯥꯖꯕꯥ ꯌꯥꯕꯥ ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯏꯃꯞꯂꯥꯟꯇ ꯁꯞꯂꯥꯏꯌꯔꯁꯤꯡ ꯈꯅꯕꯗꯥ ꯃꯃꯂꯁꯤꯡ ꯆꯥꯡꯗꯝꯅꯕꯗꯒꯤ ꯍꯦꯟꯅꯥ ꯃꯊꯧ ꯇꯥꯏ꯫ ꯗꯤꯁ꯭ꯠꯔꯤꯕ꯭ꯌꯨꯇꯔꯁꯤꯡꯅꯥ ꯀ꯭ꯕꯥꯂꯤꯇꯤ ꯁꯤꯁ꯭ꯇꯦꯃꯁꯤꯡ, ꯔꯦꯒꯨꯂꯦꯇꯔꯤ ꯔꯦꯗꯤꯑꯣ, ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯤꯡ ꯀꯦꯄꯦꯕꯤꯂꯤꯇꯤ, ꯑꯃꯁꯨꯡ ꯂꯣꯡ-ꯇꯔꯝ ꯁꯞꯂꯥꯏ ꯁ꯭ꯇꯦꯕꯤꯂꯤꯇꯤ ꯏꯚꯥꯂꯨꯑꯦꯠ ꯇꯧꯕꯥ ꯃꯊꯧ ꯇꯥꯏ꯫ ꯃꯃꯜ ꯂꯦꯞꯄꯒꯤ ꯃꯥꯏꯄꯥꯀꯄꯥ ꯑꯃꯅꯥ ꯀꯝꯞꯂꯥꯏꯑꯦꯟꯁ ꯍꯦꯗ-ꯑꯦꯛ, ꯕꯦꯀꯑꯣꯔꯗꯔ ꯁ꯭ꯄꯥꯏꯔꯦꯜ ꯅꯠꯠꯔꯒꯥ ꯅꯍꯥꯛꯀꯤ ꯍꯣꯁ꯭ꯄꯤꯇꯥꯜ ꯑꯦꯀꯥꯎꯟꯇꯁꯤꯡꯒꯥ ꯂꯣꯌꯅꯅꯥ ꯀ꯭ꯔꯦꯗꯤꯕꯤꯂꯤꯇꯤ ꯍꯤꯠ ꯑꯣꯏꯅꯥ ꯑꯣꯟꯊꯣꯀꯄꯥ ꯌꯥꯏ꯫

ꯒꯥꯏꯗꯂꯥꯏꯟ ꯑꯁꯤ ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯁꯞꯂꯥꯏꯌꯔ ꯀ꯭ꯕꯥꯂꯤꯐꯤꯀꯦꯁꯅꯒꯤꯗꯃꯛꯇꯥ ꯑꯦꯋꯦꯌꯔꯅꯦꯁ-ꯁ꯭ꯇꯦꯖ ꯐ꯭ꯔꯦꯃꯋꯥꯔꯛ ꯑꯃꯥ ꯄꯥꯝꯂꯤꯕꯥ ꯁꯦꯃꯈꯤꯕꯅꯤ ꯃꯥꯂꯦꯃꯒꯤ ꯗꯤꯁ꯭ꯠꯔꯤꯕ꯭ꯌꯨꯇꯔꯁꯤꯡ ꯑꯃꯁꯨꯡ ꯍꯣꯁ꯭ꯄꯤꯇꯥꯜ ꯄ꯭ꯔꯣꯛꯌꯨꯔꯃꯦꯟꯇ ꯇꯤꯃꯁꯤꯡꯒꯤꯗꯃꯛꯇꯥ -ꯃꯔꯨꯑꯣꯏꯅꯥ ꯀꯔꯤꯒꯨꯝꯕꯥ ꯅꯍꯥꯛꯅꯥ ꯂꯃꯗꯝ ꯀꯌꯥꯗꯥ ꯌꯣꯜꯂꯤꯕꯥ ꯅꯠꯠꯔꯒꯥ ꯅꯍꯥꯛꯅꯥ ꯂꯦꯇꯤꯟ ꯑꯃꯦꯔꯤꯀꯥꯗꯥ ꯄꯥꯀꯊꯣꯛ ꯆꯥꯎꯊꯣꯛꯂꯤꯕꯥ ꯑꯣꯏꯔꯕꯗꯤ (ꯑꯦꯜ.ꯑꯦ.ꯇꯤ.ꯑꯦꯝ.) . ꯃꯁꯤꯅꯥ ꯀꯔꯤ ꯔꯤꯛꯕꯦꯁ꯭ꯠ ꯇꯧꯒꯗꯒꯦ, ꯃꯁꯤ ꯀꯔꯝꯅꯥ ꯚꯦꯔꯤꯐꯥꯏ ꯇꯧꯒꯗꯒꯦ ꯑꯃꯁꯨꯡ ꯀꯔꯤꯅꯥ ꯅꯍꯥꯀꯄꯨ ꯊꯃꯖꯤꯅꯒꯗꯒꯦ ꯍꯥꯌꯕꯗꯨꯗꯥ ꯃꯤꯠꯌꯦꯡ ꯊꯝꯂꯤ꯫

ꯑꯥꯔꯇꯤꯀꯜ ꯑꯁꯤ ꯃꯤꯑꯣꯏꯕꯒꯤ ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯏꯃꯞꯂꯥꯟꯇ ꯑꯃꯁꯨꯡ ꯁꯔꯖꯤꯀꯦꯜ ꯏꯅꯁ꯭ꯠꯔꯨꯃꯦꯟꯇꯁꯤꯡ (ꯚꯦꯇꯦꯔꯤꯅꯥꯔꯤ ꯅꯠꯠꯔꯒꯥ ꯄꯦꯠ ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛꯁ ꯅꯠꯇꯦ)ꯒꯤ ꯃꯇꯥꯡꯗꯥ ꯑꯣꯏꯔꯤ꯫

ꯃꯔꯨꯑꯣꯏꯕꯥ ꯇꯦꯀꯑꯣꯌꯦꯁꯤꯡ꯫

• ꯋꯥꯁꯀꯁꯤꯡ ꯅꯠꯇꯅꯥ ꯗꯣꯛꯌꯨꯃꯦꯟꯇꯁꯤꯡꯗꯒꯤ ꯍꯧꯒꯗꯕꯅꯤ: ꯀ꯭ꯕꯥꯂꯤꯇꯤ ꯁꯤꯁ꯭ꯇꯦꯝ ꯁ꯭ꯀꯣꯞ, ꯗꯤꯚꯥꯏꯁ ꯔꯦꯒꯨꯂꯦꯇꯔꯤ ꯄꯥꯊꯀꯤ ꯏꯚꯤꯗꯦꯟꯁ, ꯑꯃꯁꯨꯡ ꯇ꯭ꯔꯦꯁꯤꯕꯤꯂꯤꯇꯤ꯫

• FDA 510(k) ꯑꯁꯤ ꯌꯨꯅꯤꯚꯔꯁꯦꯜ ꯑꯣꯏꯗꯦ— ꯑꯌꯥꯝꯕꯥ ꯀ꯭ꯂꯥꯁ I ꯑꯃꯁꯨꯡ ꯀ꯭ꯂꯥꯁ II ꯗꯤꯚꯥꯏꯁ ꯈꯔꯗꯤ ꯑꯦꯛꯁꯦꯝꯄ ꯇꯧꯕꯥ ꯌꯥꯏ , ꯃꯔꯝ ꯑꯗꯨꯅꯥ ꯅꯍꯥꯛꯀꯤ ꯊꯕꯛ ꯑꯁꯤ ꯗꯤꯚꯥꯏꯁ ꯀ꯭ꯂꯥꯁꯤꯐꯤꯀꯦꯁꯟ ꯑꯃꯁꯨꯡ ꯑꯦꯛꯁꯦꯝꯄꯁꯟ ꯂꯤꯃꯤꯠꯁꯤꯡ ꯚꯦꯔꯤꯐꯥꯏ ꯇꯧꯕꯅꯤ, 'ꯑꯦꯛꯁꯦꯝꯄꯁꯟ' ꯑꯁꯤ ꯀꯝꯕꯜ ꯄꯥꯎꯈꯨꯝ ꯑꯃꯥ ꯑꯣꯏꯅꯥ ꯌꯥꯕꯥ ꯅꯠꯇꯦ꯫

• ꯑꯥꯏ.ꯑꯦꯁ.ꯑꯣ.꯱꯳꯴꯸꯵ ꯑꯁꯤ ꯀꯣꯔ ꯁꯤꯒꯅꯦꯜ ꯑꯃꯥ ꯑꯣꯏꯅꯥ ꯂꯧꯕꯥ; ꯑꯦꯐ.ꯗꯤ.ꯑꯦ.ꯒꯤ ꯲꯰꯲꯶ꯀꯤ ꯀ꯭ꯕꯥꯂꯤꯇꯤ-ꯁꯤꯁ꯭ꯇꯦꯝ ꯁꯤꯐꯠ ꯑꯁꯤ ꯑꯥꯏ.ꯑꯦꯁ.ꯑꯣ.꯱꯳꯴꯸꯵ꯒꯤ ꯑꯦꯛꯁꯄꯦꯛꯇꯦꯁꯅꯁꯤꯡꯒꯥ ꯍꯦꯟꯅꯥ ꯅꯛꯅꯥ ꯃꯥꯟꯅꯩ꯫

• ꯁ꯭ꯇꯦꯖ ꯑꯅꯤꯒꯤ ꯄ꯭ꯔꯣꯁꯦꯁ ꯑꯃꯥ ꯆꯠꯊꯕꯥ: (1) ꯁꯦꯝꯄꯂꯁꯤꯡꯒꯤ ꯃꯃꯥꯡꯗꯥ ꯁꯞꯂꯥꯏꯌꯔ ꯑꯗꯨ ꯀ꯭ꯕꯥꯂꯤꯐꯥꯏ ꯇꯧꯕꯥ, ꯃꯗꯨꯒꯤ ꯃꯇꯨꯡꯗꯥ (2) ꯑꯍꯥꯅꯕꯥ POꯒꯤ ꯃꯃꯥꯡꯗꯥ ꯀꯟꯠꯔꯣꯂꯁꯤꯡ ꯚꯦꯂꯤꯗꯦꯠ ꯇꯧꯕꯥ꯫

ꯃꯔꯨꯑꯣꯏꯕꯥ ꯇꯦꯛ-ꯑꯣꯐ : ꯔꯤꯁ꯭ꯛ ꯍꯟꯊꯍꯟꯅꯕꯒꯤ ꯈ꯭ꯕꯥꯏꯗꯒꯤ ꯌꯥꯡꯅꯥ ꯄꯥꯝꯕꯩꯗꯤ ꯅꯍꯥꯛꯅꯥ ꯁꯞꯂꯥꯏꯌꯔ ꯈꯨꯗꯤꯡꯃꯛꯇꯥ ꯍꯥꯌꯖꯔꯤꯕꯥ ꯑꯗꯨ ꯁ꯭ꯇꯦꯟꯗꯔꯗ ꯑꯣꯏꯍꯅꯕꯅꯤ-ꯃꯗꯨꯒꯤ ꯃꯇꯨꯡꯗꯥ ꯄꯥꯎꯈꯨꯃꯁꯤꯡ ꯑꯗꯨ ꯅꯥꯀꯜ ꯑꯃꯗꯥ ꯆꯥꯡꯗꯝꯅꯕꯅꯤ꯫

'ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯁꯞꯂꯥꯏꯌꯔꯁꯤꯡ'ꯅꯥ ꯇꯁꯦꯡꯅꯥ ꯀꯔꯤ ꯀꯣꯅꯁꯤꯜꯂꯤꯕꯅꯣ (ꯑꯗꯨꯒꯥ ꯀꯔꯤꯒꯤꯗꯃꯛꯇꯥ ꯃꯔꯨ ꯑꯣꯏꯔꯤꯕꯅꯣ)

ꯃꯤꯌꯥꯝꯅꯥ 'ꯁꯞꯂꯥꯏꯌꯔ' ꯑꯁꯤ ꯇꯣꯉꯥꯟ ꯇꯣꯉꯥꯅꯕꯥ ꯋꯥꯐꯃꯁꯤꯡ ꯍꯥꯌꯅꯕꯒꯤꯗꯃꯛ ꯁꯤꯖꯤꯟꯅꯩ: ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯔ ꯑꯃꯥ, ꯀꯟꯠꯔꯦꯛꯇ ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯔ ꯑꯃꯥ, ꯗꯤꯁ꯭ꯠꯔꯤꯕ꯭ꯌꯨꯇꯔ ꯑꯃꯥ, ꯅꯠꯔꯒꯥ ꯇ꯭ꯔꯦꯗꯤꯡ ꯀꯝꯄꯦꯅꯤ ꯑꯃꯥ ꯐꯥꯑꯣꯕꯥ꯫ ꯑꯗꯨꯒꯨꯝꯕꯥ ꯑꯦꯝꯕꯤꯒ꯭ꯌꯤ ꯑꯗꯨ ꯔꯤꯁ꯭ꯛ ꯂꯩ꯫

ꯀꯔꯤꯒꯨꯝꯕꯥ ꯅꯍꯥꯛꯅꯥ ꯁꯣꯔꯇꯂꯤꯁ꯭ꯠ ꯑꯃꯥ ꯁꯦꯝꯂꯕꯗꯤ꯫ orthopedic implant suppliers , ꯑꯍꯥꯅꯕꯥ ꯋꯥꯍꯪ ꯑꯁꯤ ꯏꯆꯝ ꯆꯝꯕꯥ ꯑꯃꯅꯤ: ꯅꯍꯥꯛꯅꯥ ꯑꯥꯏꯅꯒꯤ ꯑꯣꯏꯕꯥ ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯔ, ꯕ꯭ꯔꯥꯟꯗ ꯑꯣꯅꯔ, ꯅꯠꯔꯒꯥ ꯗꯤꯁ꯭ꯠꯔꯤꯕ꯭ꯌꯨꯇꯔ/ꯔꯤꯁꯦꯜꯂꯔ ꯑꯃꯥ ꯏꯚꯥꯂꯨꯑꯦꯠ ꯇꯧꯔꯤꯕ꯭ꯔꯥ? ꯅꯍꯥꯛꯀꯤ ꯗꯣꯛꯌꯨꯃꯦꯟꯇꯦꯁꯟ ꯆꯦꯀꯂꯤꯁ꯭ꯠ ꯑꯗꯨ ꯄꯥꯎꯈꯨꯃꯒꯤ ꯃꯇꯨꯡꯏꯟꯅꯥ ꯍꯣꯡꯏ꯫

ꯃꯁꯤ ꯇꯤꯝ ꯀꯌꯥꯅꯥ ꯃꯈꯣꯌꯒꯤ ꯁꯣꯔꯁꯤꯡ ꯂꯦꯅꯁꯤꯡ ꯈꯥꯌꯗꯣꯀꯄꯥ ꯄꯣꯏꯟꯇ ꯑꯃꯁꯨꯅꯤ: ꯋꯥꯍꯪ ꯈꯔꯗꯤ ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯏꯃꯞꯂꯥꯟꯇ ꯁꯞꯂꯥꯏꯌꯔꯁꯤꯡ (ꯂꯣꯏꯁꯤꯜꯂꯕꯥ ꯗꯤꯚꯥꯏꯁꯁꯤꯡ)ꯒꯤ ꯃꯇꯥꯡꯗꯥ ꯑꯣꯏꯔꯤ, ꯑꯗꯨꯒꯥ ꯑꯇꯣꯞꯄꯥ ꯈꯔꯅꯥ ꯅꯍꯥꯛꯀꯤ ꯄ꯭ꯔꯥꯏꯕꯦꯠ-ꯂꯦꯕꯦꯜ ꯔꯣꯗꯃꯦꯄꯇꯥ ꯃꯇꯦꯡ ꯄꯥꯡꯂꯤꯕꯥ ꯑꯣ.ꯏ.ꯑꯦꯝ./ꯑꯣ.ꯗꯤ.ꯑꯦꯝ. ꯚꯦꯇꯤꯡ ꯂꯣꯖꯤꯛ ꯑꯁꯤ ꯑꯣꯚꯔꯂꯦꯞ ꯇꯧꯏ-ꯑꯗꯨꯕꯨ ꯗꯣꯀꯨꯃꯦꯟꯇꯁꯤꯡ ꯑꯃꯁꯨꯡ ꯊꯧꯗꯥꯡꯁꯤꯡ ꯑꯁꯤꯗꯤ ꯃꯥꯟꯅꯗꯦ꯫

ꯄ꯭ꯔꯦꯛꯇꯤꯀꯦꯜ ꯔꯨꯜ ꯑꯃꯥ: ꯀꯔꯤꯒꯨꯝꯕꯥ ꯁꯞꯂꯥꯏꯌꯔ ꯑꯃꯅꯥ ꯃꯈꯣꯌꯒꯤ ꯊꯧꯗꯥꯡ (ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯔ ꯕꯅꯥꯝ ꯑꯣꯊꯣꯔꯥꯏꯖ ꯇꯧꯔꯕꯥ ꯗꯤꯁ꯭ꯠꯔꯤꯕ꯭ꯌꯨꯇꯔ ꯕꯅꯥꯝ OEM/ODM ꯄꯥꯔꯇꯅꯔ) ꯃꯌꯦꯛ ꯁꯦꯡꯅꯥ ꯇꯥꯀꯄꯥ ꯉꯃꯗ꯭ꯔꯕꯗꯤ, ꯅꯍꯥꯛꯅꯥ ꯃꯃꯜ ꯂꯦꯞꯄꯒꯤ ꯃꯇꯥꯡꯗꯥ ꯋꯥꯔꯤ ꯁꯥꯗ꯭ꯔꯤꯉꯩꯗꯥ ꯂꯦꯡꯗꯅꯥ ꯂꯩꯌꯨ ꯑꯃꯁꯨꯡ ꯃꯌꯦꯛ ꯁꯦꯡꯅꯥ ꯇꯥꯀꯄꯤꯌꯨ꯫

ꯁ꯭ꯇꯦꯖ 1: ꯅꯍꯥꯛꯅꯥ ꯁꯦꯝꯄꯂꯁꯤꯡ ꯐꯥꯎꯕꯥ ꯍꯥꯌꯗ꯭ꯔꯤꯉꯩꯗꯥ ꯀꯔꯤ ꯔꯤꯛꯕꯦꯁ꯭ꯠ ꯇꯧꯒꯗꯒꯦ꯫

ꯁ꯭ꯇꯦꯖ ꯑꯁꯤ ꯁꯞꯂꯥꯏꯌꯔ ꯑꯗꯨ ꯇꯁꯦꯡꯕꯥ, ꯀ꯭ꯕꯥꯂꯤꯐꯥꯏꯗ ꯑꯣꯏꯕꯥ ꯑꯃꯁꯨꯡ ꯗꯣꯛꯌꯨꯃꯦꯟꯇ-ꯔꯦꯗꯤ ꯑꯣꯏꯕꯥ ꯄ꯭ꯔꯃꯥꯟ ꯇꯧꯕꯒꯤ ꯃꯇꯥꯡꯗꯥ ꯑꯣꯏꯔꯤ-ꯅꯍꯥꯛꯅꯥ ꯁꯦꯝꯄꯜ ꯂꯣꯖꯤꯁ꯭ꯇꯤꯛꯁꯇꯥ ꯃꯇꯝ ꯃꯩ ꯊꯥꯗ꯭ꯔꯤꯉꯩ ꯃꯃꯥꯡꯗꯥ꯫

꯱) ꯀ꯭ꯕꯥꯂꯤꯇꯤ ꯁꯤꯁ꯭ꯇꯦꯃꯒꯤ ꯏꯕꯤꯗꯦꯟꯁ (ꯑꯃꯁꯨꯡ ꯁ꯭ꯀꯣꯞ) ꯴.

ꯍꯥꯌꯕꯤꯌꯨ:

• ꯑꯥꯏ.ꯑꯦꯁ.ꯑꯣ.꯱꯳꯴꯸꯵ ꯁꯔꯇꯤꯐꯤꯀꯦꯠ ꯑꯃꯁꯨꯡ ꯁ꯭ꯀꯣꯞ (ꯄꯤ.ꯗꯤ.ꯑꯦꯐ.ꯇꯥ ꯂꯣꯒꯣ ꯈꯛꯇꯃꯛ ꯅꯠꯇꯦ)

ꯀꯔꯤꯒꯨꯝꯕꯥ ꯅꯍꯥꯛꯅꯥ ꯃꯁꯤꯡ ꯌꯥꯝꯂꯕꯥ ꯕꯤꯗꯁꯤꯡ ꯆꯥꯡꯗꯝꯅꯔꯕꯗꯤ, ꯁꯞꯂꯥꯏꯌꯔ ꯑꯃꯅꯥ ISO 13485 ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯁꯞꯂꯥꯏꯌꯔ ꯑꯃꯥ ꯑꯣꯏꯕ꯭ꯔꯥ ꯍꯥꯌꯕꯗꯨ ꯃꯌꯦꯛ ꯁꯦꯡꯅꯥ ꯈꯪꯖꯤꯅꯕꯤꯌꯨ (ꯑꯃꯁꯨꯡ ꯁꯔꯇꯤꯐꯤꯀꯦꯠ ꯁ꯭ꯀꯣꯞ ꯑꯗꯨ ꯅꯍꯥꯛꯅꯥ ꯁꯣꯔꯁ ꯇꯧꯔꯤꯕꯥ ꯑꯀꯛꯅꯕꯥ ꯄ꯭ꯔꯗꯛꯇ ꯐꯦꯃꯤꯂꯤꯁꯤꯡꯒꯥ ꯃꯥꯟꯅꯕ꯭ꯔꯥ ꯍꯥꯌꯕꯗꯨꯁꯨ ꯈꯪꯖꯤꯅꯕꯤꯌꯨ)꯫

• ꯍꯟꯗꯛꯀꯤ ꯑꯣꯗꯤꯠꯀꯤ ꯐꯤꯚꯝ (ꯁꯔꯇꯤꯐꯤꯀꯦꯠ ꯑꯁꯤ ꯀꯔꯤ ꯕꯣꯗꯤꯅꯥ ꯄꯤꯈꯤꯕꯒꯦ, ꯑꯃꯁꯨꯡ ꯃꯁꯤꯒꯤ ꯃꯇꯝ ꯂꯣꯏꯔꯕꯥ ꯃꯇꯃꯗꯥ)

• ꯑꯋꯥꯡꯕꯥ ꯊꯥꯛꯀꯤ ꯀ꯭ꯕꯥꯂꯤꯇꯤ ꯑꯣꯚꯔꯚꯤꯌꯨ ꯑꯃꯥ: ꯀꯃꯞꯂꯦꯟꯇ ꯍꯦꯟꯗꯜ ꯇꯧꯕꯥ, ꯅꯟ-ꯀꯅꯐꯣꯔꯃꯦꯟꯁ ꯀꯟꯠꯔꯣꯂꯁꯤꯡ, ꯀꯣꯀꯍꯅꯕꯥ ꯌꯥꯕꯥ ꯑꯦꯛꯁꯟ ꯄ꯭ꯔꯣꯁꯦꯁꯁꯤꯡ꯫

ꯀꯔꯤꯒꯤꯗꯃꯛꯇꯥ ꯃꯁꯤ ꯃꯔꯨꯑꯣꯏꯕꯅꯣ: ꯑꯥꯏ.ꯑꯦꯁ.ꯑꯣ.꯱꯳꯴꯸꯵ ꯑꯁꯤ ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯔ ꯑꯃꯅꯥ ꯗꯣꯀꯨꯃꯦꯟꯇ ꯇꯧꯔꯕꯥ ꯀ꯭ꯕꯥꯂꯤꯇꯤ ꯁꯤꯁ꯭ꯇꯦꯝ ꯑꯃꯥ ꯆꯂꯥꯏꯕꯒꯤ ꯈ꯭ꯕꯥꯏꯗꯒꯤ ꯃꯌꯦꯛ ꯁꯦꯡꯕꯥ ꯃꯥꯂꯦꯃꯒꯤ ꯁꯤꯒꯅꯦꯂꯁꯤꯡꯒꯤ ꯃꯅꯨꯡꯗꯥ ꯑꯃꯅꯤ꯫ ꯉꯃꯈꯩ ꯂꯥꯟꯗꯨꯅꯥ ꯂꯩꯕꯥ ꯄ꯭ꯔꯣꯒ꯭ꯔꯥꯃꯁꯤꯡꯒꯤ ꯑꯣꯏꯅꯗꯤ (LATAM ꯌꯥꯎꯅꯥ), ꯅꯍꯥꯛꯅꯥ ꯍꯧꯖꯤꯀꯁꯨ ꯃꯥꯔꯀꯦꯠ-ꯁ꯭ꯄꯦꯁꯤꯐꯤꯛ ꯏꯚꯤꯗꯦꯟꯁ ꯃꯊꯧ ꯇꯥꯒꯅꯤ-ꯃꯔꯝ ꯑꯗꯨꯅꯥ ISO 13485 ꯑꯁꯤ ꯕꯦꯖ ꯂꯥꯏꯟ ꯑꯣꯏꯅꯥ ꯂꯧꯕꯤꯌꯨ, ꯃꯗꯨꯒꯤ ꯃꯇꯨꯡꯗꯥ ꯅꯍꯥꯛꯀꯤ ꯇꯥꯔꯒꯦꯠ ꯂꯩꯕꯥꯀꯁꯤꯡꯅꯥ ꯔꯦꯖꯤꯁ꯭ꯠꯔꯦꯁꯟ, ꯑꯣꯗꯤꯠ, ꯑꯃꯁꯨꯡ ꯍꯧꯖꯤꯛ ꯆꯠꯊꯔꯤꯕꯥ ꯀꯝꯞꯂꯥꯏꯑꯦꯟꯁꯀꯤꯗꯃꯛꯇꯥ ꯀꯔꯤ ꯃꯊꯧ ꯇꯥꯕꯒꯦ ꯍꯥꯌꯕꯗꯨ ꯚꯦꯔꯤꯐꯥꯏ ꯇꯧꯕꯤꯌꯨ꯫

꯲) ꯅꯍꯥꯛꯅꯥ ꯁꯣꯔꯁ ꯇꯧꯔꯤꯕꯥ ꯑꯀꯛꯅꯕꯥ ꯄꯣꯠꯊꯣꯀꯁꯤꯡꯒꯤꯗꯃꯛ ꯔꯦꯒꯨꯂꯦꯇꯔꯤ ꯄꯥꯊꯋꯦꯌ ꯄ꯭ꯔꯨꯐ꯫

'ꯄ꯭ꯔꯗꯛꯇꯁꯤꯡ ꯑꯁꯤ ꯀ꯭ꯂꯤꯌꯔ/ꯔꯦꯖꯤꯁ꯭ꯇꯔ ꯇꯧꯔꯕꯔꯥ?' ꯍꯥꯌꯕꯁꯤ ꯊꯣꯏꯗꯣꯛ ꯍꯦꯟꯗꯣꯀꯄꯥ ꯋꯥꯍꯪ ꯑꯃꯅꯤ꯫ ꯍꯦꯟꯅ ꯐꯕ:

• ꯅꯍꯥꯛꯅꯥ ꯂꯧꯅꯕꯥ ꯊꯧꯔꯥꯡ ꯇꯧꯔꯤꯕꯥ ꯄꯣꯠꯊꯣꯛ ꯏꯃꯨꯡ ꯈꯨꯗꯤꯡꯃꯛꯀꯤ ꯑꯣꯏꯅꯥ, ꯅꯍꯥꯛꯀꯤ ꯇꯥꯔꯒꯦꯠ ꯃꯥꯔꯀꯦꯠꯁꯤꯡꯗꯥ ꯀꯔꯝꯕꯥ ꯗꯤꯚꯥꯏꯁ ꯀ꯭ꯂꯥꯁꯤꯐꯤꯀꯦꯁꯟ ꯑꯁꯤ ꯆꯠꯅꯕꯒꯦ ꯑꯃꯁꯨꯡ ꯃꯁꯤꯅꯥ ꯔꯦꯒꯨꯂꯦꯇꯔꯤ ꯄꯥꯊꯀꯤꯗꯃꯛꯇꯥ ꯀꯔꯤ ꯍꯥꯌꯔꯤꯕꯒꯦ ꯍꯥꯌꯅꯥ ꯍꯪꯕꯤꯌꯨ꯫

• ꯌꯣꯜꯂꯤ꯫ ꯅꯍꯥꯛꯅꯥ ​

• ꯀꯧꯕꯥ ꯅꯍꯥꯛꯀꯤ ꯏꯅꯇꯦꯛ ꯐꯣꯔꯃꯗꯥ ꯂꯥꯏꯟ ꯑꯃꯥ ꯍꯥꯄꯆꯤꯜꯂꯨ ꯔꯦꯒꯨꯂꯦꯇꯔꯤ ꯄꯥꯊꯋꯦꯌ ꯚꯦꯔꯤꯐꯤꯀꯦꯁꯟ ꯑꯃꯁꯨꯡ (a) ꯅꯍꯥꯛꯀꯤ ꯇꯥꯔꯒꯦꯠ ꯂꯩꯕꯥꯀꯁꯤꯡꯗꯥ ꯂꯩꯕꯥ ꯄ꯭ꯔꯗꯛꯇ ꯐꯦꯃꯤꯂꯤ ꯑꯗꯨꯒꯤꯗꯃꯛ ꯔꯦꯖꯤꯁ꯭ꯠꯔꯦꯁꯟ/ ꯀ꯭ꯂꯤꯌꯔꯦꯟꯁ ꯔꯦꯐꯥꯔꯦꯟꯁ ꯑꯃꯥ, ꯅꯠꯠꯔꯒꯥ (b) ꯉꯃꯈꯩ/ꯂꯤꯃꯤꯇꯦꯁꯅꯁꯤꯡ ꯌꯥꯎꯅꯥ ꯀ꯭ꯂꯦꯝ ꯇꯧꯔꯕꯥ 'ꯑꯦꯛꯁꯦꯝꯄꯁꯟ,' ꯑꯃꯍꯦꯛꯇꯒꯤ ꯗꯣꯛꯌꯨꯃꯦꯟꯇ ꯇꯧꯔꯕꯥ ꯌꯨꯝꯐꯝ ꯑꯃꯥ ꯃꯊꯧ ꯇꯥꯏ꯫

⚠️ ꯆꯦꯀꯁꯤꯅꯋꯥ : 'ꯑꯦꯛꯁꯦꯝꯄꯠ' ꯍꯥꯌꯕꯁꯤꯅꯥ ꯀꯩꯗꯧꯉꯩꯗꯥ 'ꯑꯅꯔꯦꯒꯨꯂꯦꯇꯦꯗ ꯍꯥꯌꯕꯅꯤ꯫' ꯃꯁꯤꯅꯥ ꯃꯍꯧꯁꯥꯅꯥ ꯖꯨꯔꯤꯁꯗꯤꯛꯁꯟ ꯑꯗꯨꯗꯥ ꯂꯩꯔꯤꯕꯥ ꯗꯤꯚꯥꯏꯁ ꯃꯈꯜ ꯑꯗꯨꯒꯤꯗꯃꯛ ꯑꯀꯛꯅꯕꯥ ꯄ꯭ꯔꯤꯃꯥꯔꯀꯦꯠ ꯁ꯭ꯇꯦꯞ ꯑꯃꯥ ꯃꯊꯧ ꯇꯥꯗꯦ ꯍꯥꯌꯕꯅꯤ—ꯑꯇꯣꯞꯄꯥ ꯀꯟꯠꯔꯣꯂꯁꯤꯡ ꯍꯧꯖꯤꯀꯁꯨ ꯆꯠꯅꯔꯤ꯫

꯳) ꯇ꯭ꯔꯦꯁꯤꯕꯤꯂꯤꯇꯤ ꯑꯃꯁꯨꯡ ꯂꯦꯕꯦꯂꯤꯡ ꯔꯦꯗꯤꯑꯣ꯫

ꯃꯈꯥꯗꯥ ꯄꯤꯔꯤꯕꯥ ꯑꯁꯤꯒꯤ ꯃꯌꯦꯛ ꯁꯦꯡꯕꯥ ꯃꯁꯛ ꯈꯪꯗꯣꯛꯅꯕꯥ ꯍꯥꯌꯕꯤꯌꯨ:

• ꯂꯣꯠ/ꯁꯤꯔꯤꯑꯦꯜ ꯇ꯭ꯔꯦꯁꯤꯕꯤꯂꯤꯇꯤ (ꯃꯈꯣꯌꯅꯥ ꯂꯣꯏꯁꯤꯜꯂꯕꯥ ꯗꯤꯚꯥꯏꯁꯇꯒꯤ ꯔꯣ ꯃꯦꯇꯔꯤꯌꯦꯂꯁꯤꯡ ꯑꯃꯁꯨꯡ ꯄ꯭ꯔꯣꯁꯦꯁꯁꯤꯡꯗꯥ ꯃꯇꯧ ꯀꯔꯝꯅꯥ ꯇ꯭ꯔꯦꯛ ꯇꯧꯕꯒꯦ)

• ꯂꯦꯕꯦꯂꯤꯡ ꯀꯟꯠꯔꯣꯂꯁꯤꯡ (ꯂꯦꯕꯦꯂꯒꯤ ꯑꯍꯣꯡꯕꯁꯤꯡ ꯑꯁꯤ ꯀꯔꯝꯅꯥ ꯑꯌꯥꯕꯥ ꯄꯤꯕꯒꯦ ꯑꯃꯁꯨꯡ ꯔꯤꯂꯤꯖ ꯇꯧꯕꯒꯦ)

• ꯑꯦꯞꯂꯤꯀꯦꯕꯜ ꯑꯣꯏꯕꯥ ꯃꯐꯃꯗꯥ UDI ꯁꯦꯝ-ꯁꯥꯕꯥ (ꯌꯨꯅꯤꯛ ꯑꯥꯏꯗꯦꯟꯇꯤꯐꯥꯌꯔꯁꯤꯡ ꯑꯁꯤ ꯀꯔꯝꯅꯥ ꯃꯦꯅꯦꯖ ꯇꯧꯕꯒꯦ ꯑꯃꯁꯨꯡ ꯚꯦꯔꯤꯐꯥꯏ ꯇꯧꯕꯒꯦ)

ꯀꯔꯤꯒꯨꯝꯕꯥ ꯅꯍꯥꯛꯅꯥ ꯃꯁꯤꯡ ꯌꯥꯝꯂꯕꯥ ꯍꯣꯁ꯭ꯄꯤꯇꯥꯜ ꯁꯤꯁ꯭ꯇꯦꯃꯁꯤꯡꯗꯥ ꯌꯦꯟꯊꯣꯛꯂꯕꯗꯤ, UDI ꯇ꯭ꯔꯦꯁꯤꯑꯦꯕꯤꯂꯤꯇꯤ ꯃꯦꯗꯤꯀꯦꯜ ꯗꯤꯚꯥꯏꯁꯁꯤꯡ ꯑꯁꯤ ꯅꯟ-ꯅꯦꯒꯣꯁꯤꯑꯦꯕꯜ ꯀꯦꯄꯦꯕꯤꯂꯤꯇꯤ ꯑꯃꯥ ꯑꯣꯏꯅꯥ ꯂꯧꯕꯤꯌꯨ: ꯅꯍꯥꯛꯅꯥ ꯇ꯭ꯔꯦꯁꯤꯑꯦꯕꯤꯂꯤꯇꯤ, ꯐꯤꯜꯗ ꯑꯦꯛꯁꯅꯁꯤꯡ, ꯑꯃꯁꯨꯡ ꯗꯣꯛꯌꯨꯃꯦꯟꯇꯦꯁꯟ ꯔꯤꯛꯕꯦꯁ꯭ꯇꯁꯤꯡ ꯏꯝꯞꯔꯣꯚꯥꯏꯖ ꯇꯧꯗꯅꯥ ꯁꯄꯣꯔꯠ ꯇꯧꯕꯥ ꯉꯝꯕꯥ ꯁꯞꯂꯥꯏꯌꯔ ꯑꯃꯥ ꯃꯊꯧ ꯇꯥꯏ꯫

ꯀꯔꯤꯒꯨꯝꯕꯥ ꯅꯍꯥꯛꯅꯥ ꯁ꯭ꯇꯦꯖ ꯑꯁꯤꯗꯥ ꯃꯄꯨꯡꯐꯥꯕꯥ ꯂꯦꯕꯦꯜ ꯄꯦꯀꯦꯠ ꯑꯃꯥ ꯃꯊꯧ ꯇꯥꯗ꯭ꯔꯕꯁꯨ, ꯅꯍꯥꯛꯅꯥ ꯁꯞꯂꯥꯏꯌꯔ ꯑꯗꯨꯗꯥ ꯀꯟꯠꯔꯣꯜ ꯇꯧꯔꯕꯥ ꯁꯤꯁ꯭ꯇꯦꯝ ꯑꯃꯥ ꯂꯩ ꯍꯥꯌꯕꯥ ꯈꯪꯕꯥ ꯄꯥꯝꯃꯤ-ꯑꯔꯣꯏꯕꯥ ꯃꯤꯅꯤꯠꯀꯤ ꯁ꯭ꯞꯔꯦꯗꯁꯤꯠ ꯑꯃꯥ ꯅꯠꯇꯦ꯫

꯴) ꯃꯦꯇꯔꯤꯑꯦꯂꯁꯤꯡ ꯑꯃꯁꯨꯡ ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯤꯡ ꯀꯟꯠꯔꯣꯂꯁꯤꯡ (ꯁꯞꯂꯥꯏꯌꯔ-ꯔꯦꯗꯤ ꯚꯔꯖꯟ)

ꯑꯦꯋꯦꯌꯔꯅꯦꯁꯀꯤ ꯊꯥꯛꯇꯥ, ꯑꯗꯣꯝꯅꯥ ꯃꯄꯨꯡ ꯐꯥꯕꯥ ꯇꯦꯛꯅꯤꯀꯦꯜ ꯗꯣꯁꯤꯌꯔ ꯑꯃꯥ ꯃꯊꯧ ꯇꯥꯗꯦ꯫ ꯅꯍꯥꯛꯅꯥ ꯃꯈꯥꯒꯤꯁꯤꯡ ꯑꯁꯤꯒꯤ ꯀꯟꯠꯔꯣꯜ ꯇꯧꯔꯕꯥ ꯄꯥꯎꯈꯨꯃꯁꯤꯡ ꯄꯥꯝꯃꯤ:

• ꯁꯤꯖꯤꯟꯅꯔꯤꯕꯥ ꯁ꯭ꯇꯦꯟꯗꯔꯗ ꯏꯃꯞꯂꯥꯟꯇ ꯃꯦꯇꯔꯤꯑꯦꯂꯁꯤꯡ ꯑꯁꯤ ꯀꯔꯤꯅꯣ (ꯈꯨꯗꯝ ꯑꯣꯏꯅꯥ, ꯇꯥꯏꯇꯅꯤꯌꯝ ꯑꯦꯂꯣꯌꯁꯤꯡ, ꯁ꯭ꯇꯦꯅꯂꯦꯁ ꯁ꯭ꯇꯤꯜ, ꯄꯤ.ꯏ.ꯏ.ꯀꯦ.) ꯑꯃꯁꯨꯡ ꯁꯔꯇꯤꯐꯤꯀꯦꯠꯁꯤꯡ ꯑꯁꯤ ꯀꯔꯝꯅꯥ ꯊꯝꯂꯤꯕꯅꯣ?

• ꯃꯔꯨꯑꯣꯏꯕꯥ ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯤꯡ ꯄ꯭ꯔꯣꯁꯦꯁꯁꯤꯡ (ꯃꯦꯁꯤꯟ ꯇꯧꯕꯥ, ꯐꯤꯅꯤꯁꯤꯡ, ꯁꯦꯡꯗꯣꯀꯄꯥ) ꯑꯁꯤ ꯀꯔꯤꯅꯣ ꯑꯃꯁꯨꯡ ꯃꯈꯣꯌ ꯑꯁꯤ ꯀꯔꯝꯅꯥ ꯌꯦꯡꯁꯤꯜꯂꯤꯕꯒꯦ?

• ꯕꯦꯆ ꯑꯃꯗꯥ ꯅꯠꯠꯔꯒꯥ ꯑꯣꯔꯗꯔ ꯑꯃꯗꯥ ꯀꯔꯤ ꯇꯦꯁ꯭ꯇꯤꯡ/ꯏꯟꯁꯄꯦꯛꯁꯟ ꯔꯤꯄꯣꯔꯇꯁꯤꯡ ꯄꯤꯕꯥ ꯌꯥꯕꯒꯦ?

ꯀꯔꯤꯒꯨꯝꯕꯥ ꯁꯞꯂꯥꯏꯌꯔ ꯑꯗꯨꯅꯥ ꯏꯟꯁꯄꯦꯛꯁꯟ ꯆꯦꯀꯄꯣꯏꯟꯇꯁꯤꯡ ꯐꯣꯡꯗꯣꯀꯄꯥ ꯉꯃꯗ꯭ꯔꯕꯗꯤ ꯅꯠꯠꯔꯒꯥ ꯁꯦꯝꯄꯜ ꯔꯤꯄꯣꯔꯠ ꯑꯃꯠꯇꯥ ꯁꯦꯌꯔ ꯇꯧꯕꯥ ꯉꯃꯗ꯭ꯔꯕꯗꯤ ꯃꯗꯨ ꯁꯤꯒꯅꯦꯜ ꯑꯃꯅꯤ꯫

꯵) ꯑꯣ.ꯏ.ꯑꯦꯝ./ꯑꯣ.ꯗꯤ.ꯑꯦꯝ.ꯒꯤ ꯄ꯭ꯔꯣꯖꯦꯛꯇꯁꯤꯡꯒꯤꯗꯃꯛꯇꯥ 'ꯀꯅꯥꯅꯥ ꯀꯔꯤ ꯇꯧꯔꯤꯕꯒꯦ' ꯃꯦꯞ ꯑꯃꯥ꯫

ꯀꯔꯤꯒꯨꯝꯕꯥ ꯅꯍꯥꯛꯅꯥ ꯄ꯭ꯔꯥꯏꯚꯦꯠ-ꯂꯦꯕꯦꯜ, ꯂꯥꯏꯠ ꯀꯁ꯭ꯇꯃꯔ, ꯅꯠꯠꯔꯒꯥ ꯀꯣ-ꯗꯤꯚꯦꯂꯄꯃꯦꯟꯇꯒꯤ ꯊꯧꯔꯥꯡ ꯇꯧꯔꯕꯗꯤ, ꯍꯪꯕꯤꯌꯨ:

• ꯗꯤꯖꯥꯏꯟ ꯀꯟꯠꯔꯣꯜ ꯀꯅꯥꯒꯤ ꯃꯄꯨ ꯑꯣꯏꯔꯤꯕꯒꯦ?

• ꯂꯦꯕꯦꯂꯤꯡꯒꯤ ꯃꯄꯨ ꯀꯅꯥꯅꯣ?

• ꯔꯦꯒꯨꯂꯦꯇꯔꯤ ꯁꯕꯃꯤꯁꯅꯁꯤꯡ ꯑꯃꯁꯨꯡ ꯄꯣꯁ꯭ꯠ-ꯃꯥꯔꯀꯦꯠ ꯁꯔꯚꯤꯂꯦꯟꯁ ꯀꯅꯥꯅꯥ ꯃꯄꯨ ꯑꯣꯏꯔꯤꯕꯒꯦ?

ꯀꯔꯤꯒꯨꯝꯕꯥ ꯅꯍꯥꯛꯅꯥ ꯑꯣ.ꯏ.ꯑꯦꯝ./ꯑꯣ.ꯗꯤ.ꯑꯦꯝ.ꯒꯤ ꯏꯚꯥꯂꯨꯑꯦꯁꯅꯒꯤꯗꯃꯛꯇꯥ ꯍꯦꯟꯅꯥ ꯂꯨꯕꯥ ꯄ꯭ꯔꯣꯛꯌꯨꯔꯃꯦꯟꯇ ꯐ꯭ꯔꯦꯃꯋꯥꯔꯛ ꯑꯃꯥ ꯃꯊꯧ ꯇꯥꯔꯕꯗꯤ, ꯑꯦꯛꯁ.ꯁꯤ.ꯃꯦꯗꯤꯀꯣꯅꯥ ꯑꯀꯨꯞꯄꯥ ꯔꯤꯁꯣꯔꯁ ꯑꯃꯥ ꯂꯩꯔꯤ: ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯑꯣ.ꯏ.ꯑꯦꯝ.&ꯑꯣ.ꯗꯤ.ꯑꯦꯝ.

ꯁ꯭ꯇꯦꯖ 2: ꯅꯍꯥꯛꯀꯤ ꯑꯍꯥꯅꯕꯥ ꯄꯔꯆꯦꯖ ꯑꯣꯔꯗꯔꯒꯤ ꯃꯃꯥꯡꯗꯥ ꯀꯔꯤ ꯚꯦꯂꯤꯗꯦꯠ ꯇꯧꯒꯗꯒꯦ꯫

ꯁ꯭ꯇꯦꯖ 1ꯅꯥ ꯅꯍꯥꯀꯄꯨ ꯁꯞꯂꯥꯏꯌꯔ ꯑꯗꯨ ꯇꯦꯁ꯭ꯠ ꯇꯧꯕꯥ ꯃꯊꯧ ꯇꯥꯏ ꯍꯥꯌꯅꯥ ꯈꯪꯍꯜꯂꯤ꯫ ꯁ꯭ꯇꯦꯖ 2 ꯑꯁꯤ ꯅꯍꯥꯛꯅꯥ ꯑꯉꯀꯄꯥ ꯌꯥꯎꯗꯅꯥ ꯁ꯭ꯀꯦꯜ ꯇꯧꯕꯥ ꯉꯃꯍꯅꯕꯅꯤ꯫

꯱) ꯆꯦꯟꯖ ꯀꯟꯠꯔꯣꯜ: ꯀꯔꯤꯒꯨꯝꯕꯥ ꯄꯣꯠꯁꯛ ꯑꯃꯅꯥ ꯍꯣꯡꯂꯀꯄꯥ ꯃꯇꯃꯗꯥ ꯀꯔꯝꯅꯥ ꯈꯉꯒꯅꯤ꯫

ꯁꯞꯂꯥꯏꯌꯔ ꯑꯗꯨꯅꯥ ꯀꯔꯝꯅꯥ ꯍꯦꯟꯗꯜ ꯇꯧꯕꯒꯦ ꯍꯥꯌꯅꯥ ꯍꯪꯕꯤꯌꯨ:

• ꯗ꯭ꯔꯣꯏꯪ/ꯁ꯭ꯄꯦꯛ ꯍꯣꯡꯂꯀꯄꯥ꯫

• ꯃꯦꯇꯔꯤꯑꯦꯜ ꯁꯞꯂꯥꯏꯌꯔ ꯍꯣꯡꯂꯀꯄꯥ꯫

• ꯄ꯭ꯔꯣꯁꯦꯁꯀꯤ ꯑꯍꯣꯡꯕꯥ (ꯈꯨꯗꯝ ꯑꯣꯏꯅꯥ, ꯁꯔꯐꯦꯁ ​​ꯇ꯭ꯔꯤꯠꯃꯦꯟꯇ, ꯁꯦꯡꯗꯣꯀꯄꯥ)

ꯃꯗꯨꯒꯤ ꯃꯇꯨꯡꯗꯥ ꯄ꯭ꯔꯦꯛꯇꯤꯀꯦꯜ ꯑꯣꯏꯕꯥ ꯋꯥꯍꯪ ꯑꯁꯤ ꯍꯪꯕꯤꯌꯨ: 'ꯑꯩꯈꯣꯌꯅꯥ ꯀꯔꯝꯅꯥ ꯅꯣꯇꯤꯐꯥꯏ ꯇꯧꯒꯅꯤ, ꯑꯃꯁꯨꯡ ꯑꯩꯈꯣꯌꯅꯥ ꯀꯔꯤ ꯗꯣꯀꯨꯃꯦꯟꯇꯁꯤꯡ ꯐꯪꯒꯅꯤ?'

꯲) ꯀꯃꯞꯂꯦꯟꯇ ꯍꯦꯟꯗꯜ ꯇꯧꯕꯥ, ꯁꯤ.ꯑꯦ.ꯄꯤ.ꯑꯦ., ꯑꯃꯁꯨꯡ ꯐꯤꯜꯗ ꯑꯦꯛꯁꯟ ꯁꯦꯝ ꯁꯥꯕꯥ꯫

ꯃꯈꯣꯌꯒꯤ ꯃꯄꯨꯡꯐꯥꯕꯥ CAPA ꯐꯥꯏꯜ ꯑꯗꯨ ꯅꯍꯥꯛꯅꯥ ꯃꯊꯧ ꯇꯥꯗꯦ꯫ ꯅꯍꯥꯛꯅꯥ ꯃꯊꯧ ꯇꯥꯔꯤꯕꯁꯤꯡ ꯑꯗꯨꯗꯤ:

• ꯃꯈꯣꯌꯒꯤ ꯀꯃꯞꯂꯦꯟꯇ ꯏꯅꯇꯦꯛ ꯐ꯭ꯂꯣ (ꯃꯈꯣꯌꯅꯥ ꯀꯔꯤ ꯗꯦꯇꯥ ꯀꯦꯄꯆꯔ ꯇꯧꯔꯤꯕꯒꯦ)

• ꯃꯈꯣꯌꯅꯥ ꯅꯟ-ꯀꯅꯐꯣꯔꯃꯤꯇꯤꯁꯤꯡ ꯀꯔꯝꯅꯥ ꯊꯤꯖꯤꯅꯕꯒꯦ꯫

• ꯃꯈꯣꯌꯅꯥ ꯃꯇꯧ ꯀꯔꯝꯅꯥ ꯄꯥꯔꯇꯅꯔꯁꯤꯡꯗꯥ ꯄꯣꯇꯦꯟꯁꯤꯌꯦꯜ ꯐꯤꯜꯗ ꯏꯁꯨꯁꯤꯡ ꯄꯥꯎ ꯐꯥꯑꯣꯅꯕꯒꯦ꯫

ꯀꯃꯞꯂꯦꯟꯇ ꯑꯃꯁꯨꯡ ꯀꯣꯀꯍꯅꯕꯥ ꯌꯥꯕꯥ ꯊꯕꯀꯁꯤꯡꯒꯤꯗꯃꯛꯇꯥ ꯗꯤꯁꯤꯞꯂꯤꯟ ꯂꯩꯕꯥ ꯂꯨꯞ ꯑꯃꯥ ꯐꯣꯡꯗꯣꯀꯄꯥ ꯉꯃꯗꯕꯥ ꯁꯞꯂꯥꯏꯌꯔꯁꯤꯡꯅꯥ ꯁ꯭ꯀꯦꯂꯗꯥ ꯊꯥꯖꯕꯥ ꯊꯝꯕꯥ ꯌꯥꯝꯅꯥ ꯂꯨꯏ꯫

꯳) ꯄꯦꯀꯦꯖꯤꯡ/ꯁ꯭ꯇꯦꯔꯤꯂꯥꯏꯖꯦꯁꯅꯒꯤ ꯑꯦꯛꯁꯄꯦꯛꯇꯦꯁꯅꯁꯤꯡ—ꯀꯔꯤꯒꯨꯝꯕꯥ ꯅꯍꯥꯛꯀꯤ ꯄꯔꯆꯦꯖ ꯑꯗꯨꯒꯥ ꯃꯔꯤ ꯂꯩꯅꯕꯈꯛꯇꯗꯥ꯫

ꯄꯣꯠꯊꯣꯛ ꯈꯨꯗꯤꯡꯃꯛ ꯁ꯭ꯇꯦꯔꯥꯏꯜ ꯑꯣꯏꯅꯥ ꯌꯣꯜꯂꯤ꯫ ꯑꯗꯨꯕꯨ ꯀꯔꯤꯒꯨꯝꯕꯥ ꯅꯍꯥꯛꯅꯥ ꯁ꯭ꯇꯦꯔꯤꯜ-ꯄꯦꯛ ꯇꯧꯔꯕꯥ ꯄꯣꯠꯊꯣꯀꯁꯤꯡ ꯁꯣꯔꯁ ꯇꯧꯔꯕꯗꯤ (ꯅꯠꯠꯔꯒꯥ ꯁ꯭ꯇꯦꯔꯤꯜ ꯕꯦꯔꯤꯌꯥꯔ ꯏꯟꯇꯤꯒ꯭ꯔꯤꯇꯤꯒꯤꯗꯃꯛꯇꯥ ꯁꯞꯂꯥꯏꯌꯔꯗꯥ ꯊꯥꯖꯕꯥ ꯊꯝꯂꯕꯗꯤ), ꯃꯈꯥꯗꯥ ꯄꯤꯔꯤꯕꯁꯤꯡꯁꯤ ꯍꯪꯕꯤꯌꯨ:

• ꯄꯦꯀꯦꯖꯤꯡ ꯚꯦꯂꯤꯗꯦꯁꯅꯒꯤ ꯁꯃꯖꯤꯟꯅꯐꯝ꯫

• ꯗꯤꯁ꯭ꯠꯔꯤꯕ꯭ꯌꯨꯁꯟ/ꯁꯤꯄꯤꯡ ꯇꯦꯁ꯭ꯇꯤꯡ ꯑꯦꯞꯔꯣꯆ꯫

• ꯁꯦꯂꯐ-ꯂꯥꯏꯐ ꯏꯚꯤꯗꯦꯟꯁ ꯑꯦꯞꯔꯣꯆ꯫

ꯀꯔꯤꯒꯨꯝꯕꯥ ꯁ꯭ꯇꯦꯔꯤꯜ ꯚꯦꯂꯤꯗꯦꯁꯟ ꯑꯁꯤ ꯅꯍꯥꯛꯀꯤ ꯁ꯭ꯀꯣꯄꯀꯤ ꯁꯔꯨꯛ ꯑꯃꯥ ꯑꯣꯏꯗ꯭ꯔꯕꯗꯤ, ꯁꯦꯛꯁꯟ ꯑꯁꯤ ꯌꯥꯝꯅꯥ ꯂꯥꯏꯅꯥ ꯊꯝꯃꯨ ꯑꯃꯁꯨꯡ ꯅꯍꯥꯛꯅꯥ ꯀꯔꯤꯒꯤꯗꯃꯛꯇꯥ ꯗꯥꯌꯠꯕ ꯂꯧꯔꯤꯕꯒꯦ ꯍꯥꯌꯕꯗꯨꯒꯥ ꯆꯥꯡꯗꯝꯅꯕꯗꯥ ꯁꯞꯂꯥꯏꯌꯔ ꯑꯗꯨꯅꯥ ꯀꯔꯤꯒꯤꯗꯃꯛꯇꯥ ꯗꯥꯌꯠꯕ ꯂꯧꯔꯤꯕꯒꯦ ꯍꯥꯌꯕꯗꯨ ꯗꯣꯛꯌꯨꯃꯦꯟꯇ ꯇꯧ꯫

꯴) ꯅꯍꯥꯛꯀꯤ ꯔꯤꯁ꯭ꯛ ꯇꯣꯂꯔꯦꯟꯁꯀꯥ ꯃꯥꯟꯅꯕꯥ ꯂꯣꯖꯤꯁ꯭ꯇꯤꯛꯁ ꯑꯃꯁꯨꯡ ꯏꯅꯀꯣꯇꯔꯃꯁꯤꯡ꯫

ꯍꯥꯌꯕꯤꯌꯨ:

• ꯄ꯭ꯔꯗꯛꯇ ꯐꯦꯃꯤꯂꯤꯒꯤ ꯃꯇꯨꯡꯏꯟꯅꯥ ꯁ꯭ꯇꯦꯟꯗꯔꯗ ꯂꯤꯗ ꯇꯥꯏꯃꯁꯤꯡ꯫

• ꯕꯦꯀꯑꯣꯔꯗꯔ ꯀꯝꯝꯌꯨꯅꯤꯀꯦꯁꯟ ꯑꯦꯛꯁꯄꯦꯛꯇꯦꯁꯅꯁꯤꯡ꯫

• ꯁꯤꯄꯤꯡ ꯇꯔꯃꯁꯤꯡ (ꯏꯅꯀꯣꯇꯔꯃꯁ) ꯑꯃꯁꯨꯡ ꯏꯝꯄꯣꯔꯠ ꯁꯄꯣꯔꯠ (ꯀꯁ꯭ꯇꯃꯁ ꯄꯦꯄꯔꯋꯥꯔꯛ, ꯀꯔꯤꯒꯨꯝꯕꯥ ꯑꯣꯐꯔ ꯇꯧꯔꯕꯗꯤ ꯗꯤ.ꯗꯤ.ꯄꯤ.ꯒꯤ ꯑꯣꯄꯁꯅꯁꯤꯡ)

ꯃꯁꯤꯗꯥ 'ꯑꯆꯧꯕꯥ ꯌꯨꯅꯤꯠꯀꯤ ꯃꯃꯜ' ꯑꯁꯤ ꯑꯌꯥꯝꯕꯅꯥ ꯃꯥꯌ ꯄꯥꯀꯄꯥ ꯉꯃꯗꯦ-ꯃꯔꯃꯗꯤ ꯇꯁꯦꯡꯕꯥ ꯃꯃꯜ ꯑꯁꯤ ꯊꯦꯡꯊꯕꯥ, ꯄꯥꯔꯁꯤꯑꯦꯜ ꯁꯤꯄꯃꯦꯟꯇꯁꯤꯡ, ꯑꯃꯁꯨꯡ ꯔꯤꯑꯦꯛꯇꯤꯕ ꯀꯝꯝꯌꯨꯅꯤꯀꯦꯁꯟꯗꯥ ꯎꯠꯂꯤ꯫

꯵) ꯄꯣꯔꯇꯐꯣꯂꯤꯑꯣ ꯐꯤꯠ: ꯃꯈꯣꯌꯅꯥ ꯅꯍꯥꯛꯀꯤ ꯍꯣꯁ꯭ꯄꯤꯇꯥꯂꯒꯤ ꯀꯁ꯭ꯇꯃꯔꯁꯤꯡꯕꯨ ꯃꯇꯝ ꯁꯥꯡꯅꯥ ꯁꯄꯣꯔꯠ ꯇꯧꯕꯥ ꯉꯃꯒꯗ꯭ꯔꯥ?

ꯄꯥꯛ ꯆꯥꯎꯔꯕꯥ ꯄꯣꯔꯇꯐꯣꯂꯤꯑꯣ ꯀꯚꯔꯦꯖ ꯑꯁꯤꯅꯥ ꯃꯇꯃꯒꯤ ꯃꯇꯨꯡ ꯏꯟꯅꯥ ꯁꯞꯂꯥꯏꯌꯔ ꯁ꯭ꯞꯔꯣꯜ (ꯑꯃꯁꯨꯡ ꯔꯦꯖꯤꯁ꯭ꯠꯔꯦꯁꯅꯒꯤ ꯍꯣꯠꯅꯕꯥ) ꯍꯟꯊꯍꯅꯕꯥ ꯉꯃꯒꯅꯤ꯫

ꯀꯔꯤꯒꯨꯝꯕꯥ ꯅꯍꯥꯛꯅꯥ ꯄꯣꯠꯊꯣꯛꯀꯤ ꯄꯥꯛ ꯆꯥꯎꯕꯥ ꯑꯗꯨ ꯊꯨꯅꯥ ꯁꯦꯅꯤꯇꯦꯁꯟ-ꯆꯦꯛ ꯇꯧꯕꯥ ꯄꯥꯝꯂꯕꯗꯤ, ꯅꯍꯥꯛꯅꯥ ꯁꯞꯂꯥꯏꯌꯔꯒꯤ ꯀꯦꯇꯦꯒꯣꯔꯤ ꯀꯚꯔꯦꯖ ꯑꯗꯨ ꯉꯁꯤ ꯅꯍꯥꯛꯅꯥ ꯌꯣꯜꯂꯤꯕꯥ ꯑꯗꯨꯒꯥ ꯆꯥꯡꯗꯝꯅꯕꯥ ꯌꯥꯏ꯫ ꯑꯦꯛꯁ.ꯁꯤ.ꯃꯦꯗꯤꯀꯣꯒꯤ ꯀꯦꯇꯥꯂꯣꯒ-ꯂꯦꯕꯦꯜ ꯑꯣꯚꯔꯚꯤꯌꯨꯒꯤꯗꯃꯛꯇꯥ, ꯌꯦꯡꯕꯤꯌꯨ꯫ ꯄ꯭ꯔꯗꯛꯇꯁꯤꯡꯒꯤ ꯄꯦꯖ꯫

ꯅꯍꯥꯀꯄꯨ ꯇꯞꯅꯥ ꯇꯞꯅꯥ ꯊꯃꯒꯗꯕꯥ ꯂꯥꯂꯍꯧꯒꯤ ꯐꯤꯔꯥꯂꯁꯤꯡ꯫

ꯔꯦꯗ ꯐ꯭ꯂꯦꯒ ꯈꯨꯗꯤꯡꯃꯛ ꯗꯤꯁ꯭ꯀꯣꯂꯤꯐꯥꯏ ꯇꯧꯗꯦ, ꯑꯗꯨꯕꯨ ꯈꯨꯗꯤꯡꯃꯛꯅꯥ ꯍꯦꯟꯅꯥ ꯂꯨꯝꯅꯥ ꯚꯦꯔꯤꯐꯤꯀꯦꯁꯟ ꯇ꯭ꯔꯤꯒꯔ ꯇꯧꯒꯗꯕꯅꯤ꯫

• ꯁ꯭ꯀꯣꯞ, ꯑꯦꯛꯁꯄꯥꯏꯔꯤ ꯗꯦꯠ, ꯅꯠꯠꯔꯒꯥ ꯏꯁꯨ ꯇꯧꯔꯤꯕꯥ ꯕꯣꯗꯤ ꯌꯥꯎꯗꯕꯥ ꯁꯔꯇꯤꯐꯤꯀꯦꯇꯁꯤꯡ꯫

• 'FDA ꯑꯦꯞꯔꯨꯚ ꯇꯧꯔꯕꯥ' ꯋꯥꯍꯩ ꯄꯔꯦꯡꯁꯤꯡ ꯑꯁꯤ ꯇꯁꯦꯡꯅꯥ ꯀ꯭ꯂꯤꯌꯔ ꯇꯧꯔꯕꯥ, ꯑꯦꯛꯁꯦꯝꯄ ꯇꯧꯔꯕꯥ, ꯅꯠꯔꯒꯥ ꯑꯦꯞꯂꯤꯀꯦꯕꯜ ꯑꯣꯏꯕꯥ ꯋꯥꯐꯃꯁꯤꯡꯒꯤ ꯃꯇꯥꯡꯗꯥ ꯃꯌꯦꯛ ꯁꯦꯡꯅꯥ ꯇꯥꯀꯄꯥ꯫

• ꯃꯌꯦꯛ ꯁꯦꯡꯗꯕꯥ ꯇ꯭ꯔꯦꯁꯤꯕꯤꯂꯤꯇꯤꯒꯤ ꯄꯥꯎꯈꯨꯝ ('ꯑꯩꯈꯣꯌꯅꯥ ꯃꯁꯤ ꯇ꯭ꯔꯦꯛ ꯇꯧꯕꯥ ꯌꯥꯏ') ꯑꯁꯤ ꯀꯔꯝꯅꯥ ꯇꯧꯕꯒꯦ ꯍꯥꯌꯕꯗꯨ ꯐꯣꯡꯗꯣꯀꯄꯥ ꯉꯃꯗꯦ꯫

• ꯗꯣꯀꯨꯃꯦꯟꯇ ꯇꯧꯔꯕꯥ ꯑꯍꯣꯡꯕꯥ ꯀꯟꯠꯔꯣꯜ ꯑꯦꯛꯁꯄꯦꯛꯇꯦꯁꯟ ꯂꯩꯇꯦ꯫

• ꯃꯌꯦꯛ ꯁꯦꯡꯕꯥ ꯏꯅꯚꯦꯟꯇꯔꯤ/ꯄ꯭ꯔꯗꯛꯁꯟ ꯄ꯭ꯂꯥꯟ ꯑꯃꯥ ꯌꯥꯑꯣꯗꯅꯥ ꯂꯤꯗ ꯇꯥꯏꯃꯗꯥ ꯑꯣꯚꯔꯞꯔꯣꯃꯤꯖ ꯇꯧꯕꯥ꯫

• ꯃꯌꯦꯛ ꯁꯦꯡꯗꯕꯥ ꯑꯥꯏꯅꯒꯤ ꯑꯣꯏꯕꯥ ꯊꯧꯗꯥꯡ (ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯔ ꯕꯅꯥꯝ ꯔꯤꯁꯦꯂꯔ)

XC ꯃꯦꯗꯤꯀꯣ ꯐꯤꯠ ꯑꯣꯏꯕꯥ ꯃꯐꯝ (ꯈꯨꯗꯝ ꯑꯣꯏꯅꯥ ꯁꯞꯂꯥꯏꯌꯔ ꯄ꯭ꯔꯣꯐꯥꯏꯜ)

ꯀꯔꯤꯒꯨꯝꯕꯥ ꯅꯍꯥꯛꯅꯥ ꯃꯊꯛꯇꯥ ꯄꯅꯈ꯭ꯔꯤꯕꯥ ꯆꯦꯀꯂꯤꯁ꯭ꯠ ꯑꯁꯤꯒꯤ ꯃꯥꯌꯣꯛꯇꯥ ꯁꯞꯂꯥꯏꯌꯔ ꯑꯃꯅꯥ ꯃꯈꯣꯌ ꯃꯁꯥꯕꯨ ꯀꯔꯝꯅꯥ ꯄꯤꯁꯤꯅꯒꯗꯒꯦ ꯍꯥꯌꯕꯒꯤ ꯈꯨꯗꯝ ꯑꯃꯥ ꯄꯥꯝꯂꯕꯗꯤ, ꯑꯦꯛꯁ.ꯁꯤ.ꯃꯦꯗꯤꯀꯣ ꯑꯁꯤ... ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯏꯃꯞꯂꯥꯟꯇ ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯔ꯫ ꯇ꯭ꯔꯥꯎꯃꯥ, ꯁ꯭ꯄꯥꯏꯅꯦꯜ, ꯖꯣꯟ, ꯁ꯭ꯄꯣꯔꯇꯁ ꯃꯦꯗꯤꯁꯤꯟ, ꯑꯃꯁꯨꯡ ꯁꯔꯖꯤꯀꯦꯜ ꯏꯅꯁ꯭ꯠꯔꯨꯃꯦꯟꯇ ꯁꯣꯂꯨꯁꯅꯁꯤꯡꯒꯥ ꯂꯣꯌꯅꯅꯥ ꯃꯥꯂꯦꯃꯒꯤ ꯗꯤꯁ꯭ꯠꯔꯤꯕ꯭ꯌꯨꯇꯔꯁꯤꯡꯗꯥ ꯃꯇꯦꯡ ꯄꯥꯡꯂꯤꯕꯥ

ꯃꯈꯣꯌꯅꯥ ꯗꯤꯁ꯭ꯠꯔꯤꯕ꯭ꯌꯨꯇꯔꯁꯤꯡꯒꯤꯗꯃꯛꯇꯥ ꯃꯔꯨ ꯑꯣꯏꯕꯥ ꯁꯔꯚꯤꯁꯁꯤꯡ ꯑꯃꯁꯨꯡ ꯁꯄꯣꯔꯇꯁꯤꯡꯁꯨ ꯐꯣꯡꯗꯣꯛꯂꯤ-ꯗꯣꯀꯨꯃꯦꯟꯇꯦꯁꯟ ꯁꯄꯣꯔꯠ, ꯇꯣꯉꯥꯟ ꯇꯣꯉꯥꯅꯕꯥ ꯀꯩꯊꯦꯂꯁꯤꯡꯗꯥ ꯔꯦꯖꯤꯁ꯭ꯠꯔꯦꯁꯟ ꯃꯦꯇꯔꯤꯑꯦꯜ ꯁꯄꯣꯔꯠ, ꯑꯃꯁꯨꯡ ꯑꯣ.ꯏ.ꯑꯦꯝ./ꯑꯣ.ꯗꯤ.ꯑꯦꯝ. ꯂꯦꯟ ꯑꯗꯨꯒꯤ ꯑꯣꯚꯔꯚꯤꯌꯨ ꯑꯃꯒꯤꯗꯃꯛꯇꯥ, ꯌꯦꯡꯕꯤꯌꯨ꯫ ꯑꯦꯛꯁꯁꯤ ꯃꯦꯗꯤꯀꯣꯒꯤ ꯑꯣ.ꯏ.ꯑꯦꯝ./ꯑꯣ.ꯗꯤ.ꯑꯦꯝ. 

ꯁꯦꯛꯁꯟ ꯑꯁꯤ ꯔꯤꯀꯃꯦꯟꯗꯦꯁꯟ ꯑꯃꯅꯤ; ꯃꯁꯤ ꯅꯍꯥꯛꯅꯥ ꯚꯦꯔꯤꯐꯤꯀꯦꯁꯅꯒꯤ ꯋꯥꯍꯪꯁꯤꯡꯗꯥ ꯍꯟꯗꯣꯀꯄꯥ ꯌꯥꯕꯥ ꯃꯈꯂꯒꯤ ꯀ꯭ꯂꯦꯃꯁꯤꯡꯒꯤ ꯈꯨꯗꯝ ꯑꯃꯅꯤ꯫

ꯃꯊꯪꯒꯤ ꯈꯣꯡꯊꯥꯡꯁꯤꯡ꯫

ꯀꯔꯤꯒꯨꯝꯕꯥ ꯅꯍꯥꯛꯅꯥ ꯁꯣꯔꯇꯂꯤꯁ꯭ꯠ ꯑꯃꯥ ꯁꯦꯝꯂꯕꯗꯤ, ꯈ꯭ꯕꯥꯏꯗꯒꯤ ꯀꯥꯟꯅꯕꯥ ꯈꯣꯡꯊꯥꯡꯗꯤ ꯅꯍꯥꯛꯀꯤ ꯁꯞꯂꯥꯏꯌꯔ-ꯀ꯭ꯕꯥꯂꯤꯐꯤꯀꯦꯁꯟ ꯄꯦꯀꯦꯠ ꯑꯗꯨ ꯁ꯭ꯇꯦꯟꯗꯔꯗꯥꯏꯖ ꯇꯧꯕꯥ ꯑꯃꯁꯨꯡ ꯀꯦꯟꯗꯤꯗꯦꯠ ꯈꯨꯗꯤꯡꯃꯛꯇꯥ ꯆꯞ ꯃꯥꯟꯅꯕꯥ ꯔꯤꯛꯕꯦꯁ꯭ꯠ ꯑꯗꯨ ꯊꯥꯕꯅꯤ꯫

ꯏꯆꯝ ꯆꯝꯕꯥ ꯁ꯭ꯇꯥꯔꯇꯑꯞ ꯀꯤꯠ ꯑꯃꯥ:

• ꯁ꯭ꯇꯦꯖ 1ꯒꯤ ꯗꯣꯛꯌꯨꯃꯦꯟꯇ ꯂꯤꯁ꯭ꯠ (ꯁꯔꯇꯁꯤꯡ, ꯁ꯭ꯀꯣꯞ, ꯔꯣꯜ ꯀ꯭ꯂꯦꯔꯤꯇꯤ)

• ꯁ꯭ꯇꯦꯖ 2ꯒꯤ ꯀꯟꯠꯔꯣꯂꯁꯤꯡꯒꯤ ꯂꯤꯁ꯭ꯠ (ꯆꯦꯟꯖ ꯀꯟꯠꯔꯣꯜ, ꯀꯃꯞꯂꯦꯟꯇ/ꯁꯤ.ꯑꯦ.ꯄꯤ.ꯑꯦ., ꯂꯣꯖꯤꯁ꯭ꯇꯤꯛꯁ)

• ꯁꯞꯂꯥꯏꯌꯔꯁꯤꯡꯗꯥ ꯂꯦꯞꯇꯅꯥ ꯁ꯭ꯀꯣꯔ ꯇꯧꯅꯕꯒꯤꯗꯃꯛ ꯄꯦꯖ ꯑꯃꯒꯤ ꯆꯥꯡꯗꯝꯅꯕꯥ ꯒ꯭ꯔꯤꯗ ꯑꯃꯥ꯫

ꯃꯦꯗꯤꯀꯦꯜ/ꯔꯦꯒꯨꯂꯦꯇꯔꯤ ꯗꯤꯁꯛꯂꯦꯃꯔ: ꯑꯥꯔꯇꯤꯀꯜ ꯑꯁꯤ ꯖꯦꯅꯦꯔꯦꯜ ꯄ꯭ꯔꯣꯛꯌꯨꯔꯃꯦꯟꯇ ꯑꯦꯖꯨꯀꯦꯁꯅꯒꯤꯗꯃꯛꯇꯅꯤ ꯑꯃꯁꯨꯡ ꯃꯁꯤ ꯃꯦꯗꯤꯀꯦꯜ ꯅꯠꯠꯔꯒꯥ ꯂꯤꯒꯦꯜ ꯑꯦꯗꯚꯥꯏꯖꯔꯤ ꯅꯠꯇꯦ꯫ ꯃꯊꯧ ꯇꯥꯕꯁꯤꯡ ꯑꯁꯤ ꯄꯣꯠꯊꯣꯛ ꯃꯈꯜ ꯑꯃꯁꯨꯡ ꯖꯨꯔꯤꯁꯗꯤꯛꯁꯅꯒꯤ ꯃꯇꯨꯡꯏꯟꯅꯥ ꯈꯦꯠꯅꯩ-ꯀ꯭ꯕꯥꯂꯤꯐꯥꯏꯗ ꯔꯦꯒꯨꯂꯦꯇꯔꯤ/ ꯀ꯭ꯕꯥꯂꯤꯇꯤ ꯂꯩꯕꯥ ꯄ꯭ꯔꯣꯐꯦꯁꯅꯦꯂꯁꯤꯡꯒꯥ ꯂꯣꯌꯅꯅꯥ ꯚꯦꯔꯤꯐꯥꯏ ꯇꯧ꯫

ꯑꯦꯐ.ꯑꯦ.ꯀ꯭ꯌꯨ

ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯏꯃꯞꯂꯥꯟꯇ ꯄꯨꯝꯅꯃꯛꯇꯥ ꯃꯐꯝ ꯈꯨꯗꯤꯡꯃꯛꯇꯥ ꯆꯞ ꯃꯥꯟꯅꯕꯥ ꯔꯦꯒꯨꯂꯦꯇꯔꯤ ꯑꯦꯞꯔꯨꯕꯦꯜ ꯃꯊꯧ ꯇꯥꯕꯔꯥ?

ꯅꯠꯇꯦ, ꯔꯦꯒꯨꯂꯦꯇꯔꯤ ꯄꯥꯊꯁꯤꯡ ꯑꯁꯤ ꯂꯩꯕꯥꯛ ꯑꯃꯁꯨꯡ ꯗꯤꯚꯥꯏꯁ ꯃꯈꯂꯒꯤ ꯃꯇꯨꯡ ꯏꯟꯅꯥ ꯈꯦꯠꯅꯩ꯫ ꯀ꯭ꯕꯥꯂꯤꯐꯤꯀꯦꯁꯟ ꯑꯁꯤ ꯌꯨꯝꯐꯝ ꯑꯣꯏꯒꯗꯕꯅꯤ ), ꯁꯞꯂꯥꯏꯌꯔ ꯑꯃꯠꯇꯗꯒꯤ ꯂꯥꯀꯄꯥ ꯋꯥꯟ-ꯁꯥꯏꯖ-ꯐꯤꯠ-ꯑꯣꯜ ꯀ꯭ꯂꯦꯝ ꯑꯃꯗꯥ ꯌꯨꯝꯐꯝ ꯑꯣꯏꯔꯣꯏꯗꯕꯅꯤ꯫ ꯃꯥꯔꯀꯦꯠ-ꯁ꯭ꯄꯦꯁꯤꯐꯤꯛ ꯗꯣꯛꯌꯨꯃꯦꯟꯇꯦꯁꯟꯗꯥ ꯅꯍꯥꯛꯅꯥ ꯌꯣꯜꯂꯤꯕꯥ ꯃꯐꯝ ꯑꯗꯨꯒꯤ (ꯑꯃꯁꯨꯡ ꯄꯣꯠꯊꯣꯛ ꯑꯗꯨ ꯀꯗꯥꯏꯗꯥ ꯁꯤꯖꯤꯟꯅꯒꯅꯤ ꯍꯥꯌꯕꯒꯤ

ꯁꯞꯂꯥꯏꯌꯔ ꯑꯃꯕꯨ ꯀ꯭ꯕꯥꯂꯤꯐꯥꯏ ꯇꯧꯅꯕꯥ ꯑꯥꯏ.ꯑꯦꯁ.ꯑꯣ.꯱꯳꯴꯸꯵ ꯃꯇꯤꯛ ꯆꯥꯕꯔꯥ?

ꯃꯁꯤ ꯑꯆꯦꯠꯄꯥ ꯍꯧꯔꯀꯐꯝ ꯑꯃꯅꯤ ꯑꯗꯨꯕꯨ ꯃꯁꯤ ꯋꯥꯔꯤ ꯄꯨꯝꯕꯥ ꯅꯠꯇꯦ꯫ ꯅꯍꯥꯛꯅꯥ ꯍꯧꯖꯤꯀꯁꯨ ꯇ꯭ꯔꯦꯁꯤꯕꯤꯂꯤꯇꯤ, ꯆꯦꯟꯖ ꯀꯟꯠꯔꯣꯜ, ꯀꯃꯞꯂꯦꯟꯇ/ꯁꯤ.ꯑꯦ.ꯄꯤ.ꯑꯦ.ꯒꯤ ꯗꯤꯁꯤꯞꯂꯤꯟ, ꯑꯃꯁꯨꯡ (ꯃꯔꯤ ꯂꯩꯅꯕꯥ ꯃꯇꯃꯗꯥ) ꯄꯦꯀꯦꯖꯤꯡ/ꯁ꯭ꯇꯦꯔꯤꯂꯥꯏꯖꯦꯁꯟ ꯚꯦꯂꯤꯗꯦꯁꯟ ꯑꯃꯁꯨꯡ ꯂꯣꯖꯤꯁ꯭ꯇꯤꯛꯁ ꯔꯤꯂꯤꯑꯦꯕꯤꯂꯤꯇꯤ ꯏꯚꯥꯜꯌꯨꯑꯦꯠ ꯇꯧꯕꯥ ꯃꯊꯧ ꯇꯥꯏ꯫

ꯁꯞꯂꯥꯏꯌꯔꯁꯤꯡ ꯚꯦꯠ ꯇꯧꯕꯥ ꯃꯇꯃꯗꯥ ꯗꯤꯁ꯭ꯠꯔꯤꯕ꯭ꯌꯨꯇꯔꯁꯤꯡꯅꯥ ꯇꯧꯕꯥ ꯈ꯭ꯕꯥꯏꯗꯒꯤ ꯆꯥꯎꯕꯥ ꯑꯁꯣꯏꯕꯥ ꯑꯗꯨ ꯀꯔꯤꯅꯣ?

ꯃꯃꯂꯗꯒꯤ ꯍꯧꯔꯒꯥ꯫ ꯑꯍꯥꯅꯕꯗꯥ ꯔꯣꯜ ꯀ꯭ꯂꯦꯔꯤꯇꯤ ꯑꯃꯁꯨꯡ ꯗꯣꯛꯌꯨꯃꯦꯟꯇꯦꯁꯟ ꯔꯦꯗꯤꯑꯣꯗꯒꯤ ꯍꯧꯔꯀꯎ, ꯃꯗꯨꯒꯤ ꯃꯇꯨꯡꯗꯥ ꯁꯦꯝꯄꯂꯁꯤꯡ ꯇꯦꯁ꯭ꯠ ꯇꯧ, ꯃꯗꯨꯒꯤ ꯃꯇꯨꯡꯗꯥ ꯅꯍꯥꯛꯅꯥ ꯀꯝꯞꯂꯥꯏꯑꯦꯟꯁ ꯑꯃꯁꯨꯡ ꯁꯞꯂꯥꯏ ꯔꯤꯁ꯭ꯛ ꯍꯟꯊꯔꯕꯥ ꯃꯇꯨꯡꯗꯥ ꯇꯔꯃꯁꯤꯡ ꯅꯦꯒꯣꯁꯤꯑꯦꯠ ꯇꯧ꯫