The trade with medical devices occupies a growing share in the economic sector not only in Bulgaria, but globally as well. Along with the development of business, constant amendments can be observed when it comes to the regulation of wholesale of medical devices.
A definition of the term “medical device” is given in the Medical Devices Act (the “MDA”), where the different categories of medical devices are listed.
More detailed information on the legal frames, the term “medical device” itself and the categories of devices, that fall under its scope, can be found in the article Medical devices. Issue of Marketing Authorization for Wholesale of Medical Devices.
For the purpose of this article, we will briefly outline the categories of medical devices, since different categories of medical devices vary in terms of the requirements relevant to their registration, clinical trials and marketing control.
Categories of medical devices
Depending on the purpose intended by the manufacturer, medical devices are distinguished by law into three main categories: in vitro diagnostic medical devices; active implantable medical devices; medical devices other than the listed above two types. Devices of this category, depending on the potential risk associated with them are divided into classes I; IIa; IIb; and III.
In this regard, the key question that traders face before they begin the wholesale of these devices is whether they need to obtain a prior permit and/or register the relevant medical device in Bulgaria?
The most common case of wholesale of medical devices in Bulgaria relates to devices that have already been placed on the market in another Member state of the European Union. In this case the medical devices are marked with a conformity assessment mark – the European Conformity Mark (CE Mark).
In the above cases:
- If it refers to Medical devices are from Class IIa or IIb,
- If these devices are marked with a conformity assessment mark (CE Mark) and
- have already been placed on the market in the European Union, they do not subject to prior registration or to the issue of a prior permit before their placement on the market in Bulgaria.
Although they are not subject to prior registration in Bulgaria, when it comes to the medical devices of Class II, a mandatory notification procedure to the competent authority, namely the Bulgarian Drug Agency (BDA), has been introduced.
How does the notification procedure proceed?
The notification procedure starts with the submission of an application form to the Bulgarian Drug Agency.
The application serves as a means to provide information regarding the specific medical device, requiring detailed data about both the device and its manufacturer.
Among these data and information are:
- Information regarding the issued EU certificate, including the certificate number and date, and the name and number of the issuing authority;
- Information regarding the release date of the device in Bulgaria;
- Information about the manufacturer: name, address, telephone number, type and scope of activity;
- Details about the wholesale distributor of medical devices:
- Information about the device: device name; a brief description of the device’s designation in Bulgarian and English language; composition of the device; trade name and catalog number, among others.
The application must be accompanied by specific documents verifying the accuracy of the information provided. These include:
- EU Certificate of Conformity
- Declaration of Conformity
- Label in Bulgarian and English language;
- Instructions for Use in Bulgarian and English language.
Upon submission of the notification form, a review is initiated by the BDA. During this process, the BDA verifies whether the device possesses all the necessary documents and authorizations for its distribution; whether all valid certificates have been issued; whether the labels and instructions for use of the respective medical device comply with legal requirements. Once all European and Bulgarian regulatory requirements are satisfied, the devices can be seamlessly distributed across the Republic of Bulgaria.
If the BDA identifies an inconsistency, such inconsistency must be rectified within the specified deadlines.
What is the deadline for notifying the BDA?
The deadline for notifying the Bulgarian Drug Agency is 14 days, as of the date on which the distribution of the medical devices has began.
An application for notification can be deposited before the distribution has began as well. The article above is for information purposes only. It is not a (binding) legal advice. For a thorough understanding of the subjects covered and prior acting on any issue discussed we kindly recommend Readers consult Ilieva, Voutcheva & Co. Law Firm attorneys at law.
