Safety of medical devices

Registration is behind us

So, we have received our first authorization for market access - our registration certificate - and we are entering the post-registration period. Now, for as long as the product is on the market, it is our job to confirm the safety of medical devices at every step. As we know, during registration we passed every conceivable safety, efficacy and quality test. But back then, pre-registration data was checked. Now, the manufacturer's task is not only to confirm the quality of each imported series/batch, but also to prove that the quality system declared and verified during registration also continues to function without fail. The experience gained during the registration period and a good and quality dossier, in which you have taken into account all post-registration risks, will help you a lot here (lcs-kz).

Post-marketing period

This period provides for full control of MI, at every stage of circulation. Monitoring the safety of medical devices is a tripartite responsibility. The manufacturer bears it to consumers, of course, maintaining the quality system in working order and controlling each batch of products before release from the site. And also reporting to the regulatory authorities in the part defined by the legislation. The regulator, in turn, creates the necessary regulations and ensures timely quality inspections, thus exercising general supervision over the market. The consumer is also not slumbering and, using medical devices, gives feedback to the manufacturer and the regulator in the manner prescribed. Thus, a pharmacovigilance system is created, the main function of which is to ensure the safety of medical devices in the market.

Regulatory and legal regulation

The conduct of safety monitoring of medical devices is regulated by several legislative norms. If we are talking about Kazakhstan, there are three main Orders that describe actions in relation to the post-registration period. Previously, there was a single technical regulation on the safety of medical devices, but it has lost its force. It was replaced by a number of other NAPs.

The CR DSM-320/2020 generally describes the rules of pharmacovigilance and all the tools used by the regulator to ensure the safe use of medical devices. This includes the submission of information from the manufacturer on clinical use and actions of all interested parties in case of detection of incidents on the market.

The KR Order DSM-282/2020 regulates the system of quality assessment or, as it used to be called, certification of registered products. Each sold batch/series of a product is subject to quality assessment. The QA procedure takes place online, in the form of declaration, without providing samples. For domestic manufacturers there is a variant of serial assessment. This is when one issued certificate can be used to sell products for three years. But for this case, a site audit is required, as well as the provision of samples.

There is also the KR Order DSM-322/2020, which describes the conditions and rules for the selection of products already in circulation. This measure is aimed at identifying low-quality products that somehow got into circulation, bypassing the previous steps. The importation and putting into circulation of products with unconfirmed safety entails various consequences, starting with a fine and up to re-export and withdrawal of registration certificate (CR DSM-322/2020). Market withdrawal takes place every two years for each item, except for certain product groups. This culling is planned and not sudden. The authorized expert organization notifies manufacturers in advance, publishing at the end of the year the list of registration certificates for which the culling is planned.

EAEU

Each country of the Union regulates the post-registration period at its national level. The actions of the regulatory system in Kazakhstan are described above. However, the Pharmacovigilance Order itself in Kazakhstan is harmonized with Decision No. 174, on the approval of the rules of MI monitoring adopted within the EAEU. This decision regulates the relations between the manufacturer, regulatory authorities of the member states of the Union and consumers in case of incidents with medical products registered within the Union. It also stipulates the types and terms of reports to be submitted in the post-sale period, as well as the responsibility of the parties.

Responsibility of the PPM

In light of stricter regulation in the area of pharmacovigilance, the role of the manufacturer's authorized representative is becoming paramount. Whereas in the past representatives were needed more for ticking boxes, now they are the first person responsible for adverse events in the territory entrusted to them, on behalf of the manufacturer. Submitting clinical use reports, collecting data from consumers, and exchanging information between the manufacturer and the authorized body are not all the responsibilities of the PSO. Market withdrawal, timely amendments, renewal of RIs, and registration of price limits are also the responsibility of the representative, not to mention the responsibility for pharmacovigilance incidents and complaints. When selecting a PSO, it is better to be fully informed in this area.