COVID: exceptions for the quarantine period
In March-April 2020, a number of legislative acts were adopted with the aim of creating a legal basis for the prevention and treatment of coronavirus disease (COVID-19), maintaining the certification system in the face of a global pandemic. The most significant are:
- exemption from VAT and import duties for certain medicines, medical devices and personal protective equipment,
- Emergency Use Authorizations for non-certified medical devices and personal protective equipment,
- remote audits for establishment and maintenance of medical devices.
1. Exemption from VAT and import duties.
The list of medical devices, medicines, disinfectants and other products that are temporarily exempted from VAT and import duties, and for which temporary priority customs clearance is assigned, was adopted by the Resolution of the Cabinet of Ministers of Ukraine No.224 dated 20.03.2020.
Depending on the development of the pandemic and the challenges faced by the health care system of Ukraine, this Resolution is regularly amended.
2. Emergency Use Authorizations for medical devices and PPE’s.
To overcome the shortage of products, a special procedure was adopted for receiving notifications from the Ministry of Health for placing of non-certified medical devices and personal protective equipment on the market. The procedure was approved by the Resolution of the Cabinet of Ministers of Ukraine No. 226 of March 20, 2020, which refers to the above-mentioned Resolution of the Cabinet of Ministers No. 224 in relation to the list of products.
To obtain permission for placing on the market of non-registered medical devices an Application and set of documents should be submitted to the Ministry of Health, for personal protective equipment – to the State Labor Service.
Authorization for placing on the market can be issued for both national and imported medical devices and personal protective equipment. A permit is issued for a one-time (non-serial) import or production, indicating the names of products, their quantities, batch numbers and/or serial numbers.
For medical devices and PPE’s placed on the market under the Emergency Use Authorization, it is not required to designate the Authorized Representative, the conformity assessment procedure is not carried out, issue of a Declaration of Conformity is not required, the person responsible for placing of the products on the market is not registered, the mark of conformity to the technical regulations is not affixed.
The procedure for issuing Emergency Use Authorization is valid until the last day of quarantine in Ukraine.
3. Remote audits.
In early April 2020, a recommendation on temporary emergency measures related to audits under quarantine restrictions was published on the website of the EU Commission. Among the proposed measures are remote audits, postponing audits as long as possible by the body’s procedures, taking into account the results of other audits (for example, under the MDSAP program), adherence to IAF standards.
The National Accreditation Agency of Ukraine (NAAU), being an associate member of the IAF, has supported the possibility of conducting remote audits during the quarantine period in Ukraine. International documents ISO / IEC 17011: 2017, IAF ID 12: 2015, IAF MD 4: 2018 are accepted as the basis for conducting remote audits.
Subsequently, many national conformity assessment bodies have developed and implemented a procedure for remote audits through video streaming.
Remote audits are applicable both for the maintenance of certification (surveillance audits and recertification) and for new conformity assessment procedures.
After the end of the quarantine restrictions, it is assumed that remote audits will be replaced by on-site audits (presence of auditors at the manufacturer’s location).