According to the applicable legislation, registration of medical devices and other medical products registered before the year 2019 should be subject to renewal. Thus, the parties involved in operations with medical devices that are publicly available on the market for more than 10 years should prepare the applications for license renewal about the products they are responsible for. The particular license renewal procedure is set forth by the present circular resolution. The authority explicitly mentions that should a party responsible for a medical device fail to comply with the aforementioned requirements, such a product would be no longer available for marketing and use in the country, and its registration would be deemed annulled.
Renewal Requirements in Detail
As set forth by the resolution, a party responsible for a medical device should apply for a medical device license renewal, which should contain, inter alia, the following documents:
- Letter from the authorized representative (agent) containing the request for renewal.
- Letter from the medical device manufacturer or authorized distributor containing the request to renew the registration of a medical device.
- Information about the initial license, together with any letters and authorizations granted by the authority concerning the product.
- An application for renewal of the registration is prepared following the respective form, which should be filled in and stamped with the company’s seal.
- Comparison table as per the form provided by the authority.
- Details about the fees paid following the applicable fee schedule.
- Declaration of the manufacturer confirming that there were no changes for the manufacturing or analyzing methods, specifications, composition, or materials).
- Initial packaging of the product (should it be subject to changes, the appropriate change management procedure should be followed).
- Valid certificate for local manufacturing facilities.
- Renewed manufacturing contract (in case the devices are manufactured under the contract).
- Details about the external and internal packaging.
- Documentation accompanying the product.
- Renewed certificates for materials and components (if applicable).
- Model details with the number and date.
- Product specification with the number and date.
- Quality analysis certificate for the final product.
- The results of manufacturing consistency examination for a new batch, covering the whole intended lifetime.
The resolution also provides a template of an application form to be filled in and stamped by an interested party. Apart from the general information, such as the name of the product and the authorized agent, or the registration number, the form should contain the following details:
- MD trade name;
- Active ingredient (for medicines);
- Name of manufacturer/country;
- JFDA approval of the manufacturing site or request of approval (date and number) for a local manufacturer;
- Name of marketing authorization holder/country;
- Packaging (including size and type, all sizes should be mentioned);
- Certificates (CE, USFDA, Free sale certificate);
- Other countries where the products are registered;
- Shelf life;
- Storage conditions;
- Composition certificate number;
- Finished product specifications;
- Method of analysis;
- Leaflet/IFU (including number and date);
- Stability assessment details (real / ongoing / accelerated).
In summary, the present circular resolution sets forth a set of documents to be submitted by a party responsible for a medical device to apply for the renewal of its registration. According to the resolution, it is necessary to provide detailed enough information about the product in question, as well as a confirmation that there were no changes to the product in comparison to the initial version which is already registered and thus allowed for marketing and use.
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