Hello All,
My company wants to register our medical device software in Macedonia. I am looking for any "required documents" or labeling information that are necessary for registration.
Can anyone please share their experience. Thank you
According to Republic of
Macedonia's Draft regulation (Draft2),
Article 132 of “Law On Medicinal Products And Medical Devices”, all medical devices marketed in the Republic of Macedonia must be labeled according with the provisions of the Law on the outer and inner packing in Macedonian language and must enclose instructions for use.
A packing of medical devices must contain, at least, the following: information on the manufacturer, i.e. supplier; information necessary for the identification of the medical device and contents of the packing; different labels like “sterile”, “custom-made”, “single use”, “for clinical trials”, if necessary; identification code; expiry period; storage conditions; and, if required, a special method of use; warnings or precautions; purpose and other information related to the proper use of the device and public health protection.
The instructions for use of medical devices must be written in “
Macedonian language”. For more details please refer Republic of Macedonia,
Ministry of Health’s website or attached document..