Grant of Operation Notice

The NAMMD grants the Operation Notice in line with provisions of Order of the Minister of Health no. 1008/2016 (please see the Legislation section) on request by natural or legal entities, to allow conduct of the following medical device-related activities:
a) import of medical devices;
b) storage and distribution of medical devices;
c) repair, maintenance, putting into service/installation of medical devices;
d) medical optics – eyeglass repair/assembly in line with specialist prescription;
e) prosthesis.

The Application form may be downloaded from the Forms and fees page.

USEFUL INFORMATION ON OPERATION NOTICE OF MEDICAL DEVICE RELATED ACTIVITIES
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SURVEYS FOR ASSESSMENT OF MEDICAL DEVICE RELATED ACTIVITIES
1. IMPORT DISTRIBUTION STORAGE SURVEY
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2. SURVEY ON OPTICS RETAIL AND DISTRIBUTION
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3. SURVEY ON ORTHOPEDIC PROSTHETICS RETAIL AND DISTRIBUTION
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4. SURVEY ON HEARING AIDS RETAIL AND DISTRIBUTION
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5. SURVEY ON OTHER TYPES OF PROSTHETICS
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6. SURVEY ON REPAIR, MAINTENANCE, PUTTING INTO SERVICE/INSTALLATION OF MEDICAL DEVICES
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7. GROUPING OF MEDICAL DEVICES
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8. CLOSURE OF NON-CONFORMITIES LETTER
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TEMPLATES
M1 DECLARATION OF ACTIVITY AREA
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M2 SPECIALIST STAFF
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M3 DECLARATION FOR MANDATORY NOTIFICATION OF MEDICAL DEVICES AND OPERATION NOTICE FOR SECOND-HAND MEDICAL DEVICES
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M4 MONITORING AND MEASUREMENT EQUIPMENT
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M5 APPLICATION FOR SURVEILLANCE ASSESSMENT
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M6 IMPORTED DISTRIBUTED STORED MEDICAL DEVICE MANUFACTURERS
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M7 CONTACT DATA
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M8 DECLARATION ON DOCUMENT ACCURACY AND RELIABILITY
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APPLICATION FOR GRANT OF OPERATION NOTICE
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APPLICATION FOR CHANGE OF OPERATION NOTICE
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APPLICATION FOR RECORD INTO THE DATA BASE OF EU/EEA MEDICAL DEVICE SERVICE PROVIDERS
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Fees for assessment for grant of operation notice are established in line with provisions of Order of the Minister of Health no. 1356/2013.

Change of operation notice

Change of operation notice requires issue of an annex to the existing operation notice, based on application by natural/legal entities, in line with provisions of Order of the Minister of Health no. 1008/2016.

The Application form may be downloaded from the Forms and fees page.

Change of operation notice and issue of the annex to the existing operation notice may only be performed after assessment of applicants in line with SOP – ASSESSMENT OF TECHNICAL-MEDICAL UNITS.

Fees for assessment for change of operation are established in line with provisions of Order of the Minister of Health no. 1356/2013.

Retaining of operation

In line with provisions of Order of the Minister of Health no. 1008/2016, natural/legal entities holders of NAMMD may retain their operation notice subject to periodic verification every two years, by surveillance assessment.

Surveillance assessment is conducted pursuant to SOP – ASSESSMENT OF TECHNICAL-MEDICAL UNITS.
Units have to submit an application for surveillance assessment with the NAMMD.

The Application form may be downloaded from (M5), under the TEMPLATES page.

Fees for assessment are established in line with provisions of Order of the Minister of Health no. 1356/2013.