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National Assembly of the Republic of Armenia

09/07/2023 | News release | Distributed by Public on 09/08/2023 00:26

Any medical product implanted into patient’s body within framework of state-targeted programmes must have a certificate of origin and a certificate of conformity issued by[...]

Any medical product implanted into patient's body within framework of state-targeted programmes must have a certificate of origin and a certificate of conformity issued by manufacturer

This is a very important amendment we are making in the law. The amendment stipulates that any medical product that is implanted into the patient's body within the framework of state-targeted programmes must have a certificate of origin and a certificate of conformity issued by the manufacturer. This was stated by the deputy Lusine Badalyan who presented the draft law on Making Addenda to the Law on Medical Assistance and Service to the Population authored by her and Narek Zeynalyan at the sitting of the NA Standing Committee on Health Care in the first reading. It was noted that the issue refers to medical services provided within the framework of the state order on September 7.

It is proposed to supplement the law with new provisions, to define that implantable medical products are those invasive medical products, including partially or completely absorbed into the body, which are completely injected into the human body through surgical intervention or replace the epithelial surface or the eye surface, and which remain at the place of injection after the surgical procedure, as well as those medical products that are partially injected into the human body through surgical intervention, and they remain at the place of injection for more than 30 days after the surgical procedure.

With another addendum, it is proposed to define that the acquisition of implantable medical products used for medical services using the latest and most expensive technologies provided within the framework of medical care and service under free conditions guaranteed by the state is carried out with the presence of a certificate of conformity (letter of authorization) and a certificate of origin issued by the manufacturer.

It is expected that with the adoption of the draft, we will have a warranty security for implantable medical products used during medical services with the use of the latest and most expensive technologies provided within the framework of medical care and service under free conditions guaranteed by the state, the necessity for repeated operations will be excluded, it will be possible to identify implantable medical products, the state's expenditures for them will be targeted and effective.

The endorsement of the Government regarding the draft was presented by the Deputy Minister of Health Armen Nazaryan.

The Committee endorsed the draft.

The debate of the drafts of the Government-authored laws on Making Amendments and Addenda to the Law on Medical Assistance and Service to the Population and on Public Health Care with the enclosed legislative packages was postponed for up to two months.