Saudi Arabia`s Food and Drug Authority (SFDA) announced the launch of an entirely new online platform for medical device manufacturers to file all submissions related to medical devices.
New Online Platform
According to the information provided in the announcement, the SFDA is the regulating authority responsible for medical device market supervision. Recently, they have implemented a new platform that will replace the multiple platforms that were operating previously. The new platform will allow medical device manufacturers to file all types of submissions associated with the registration process and post-marketing surveillance, including the following:
- Marketing authorization (MDMA),
- Submissions related to the National Registry (MDNR),
- Submissions related to the authorized representatives appointed by the manufacturers,
- Any other applications.
The Authority is going to implement the new online platform within a relatively short period of time: it was stated that all medical device manufacturers shall create their accounts with the new system till December 26, 2019. From that date, all new submissions should be filed only through the new system.
The MDMA or the Medical Device Marketing Authorization is a special procedure of online submission used to obtain the approval of the Authority allowing to place medical devices at the market of Saudi Arabia. According to the guidance published by the Authority, the MDMA should include:
- detailed information about the manufacturer of the device and its manufacturing facilities,
- description of the product (in English), its intended purpose, brand name, and model number,
- manufacturer`s device identifier number,
- Identifier number in a format in which it would be placed on labeling of the device (serial number),
- Nomenclature number (other numbers assigned by foreign regulating authorities),
- Samples of labeling,
- Instructions for use to be supplied with the device,
- List of accessories,
- List of countries where the manufacturer is going to market the device,
- Statements on the power supply and environmental factors (if applicable),
- Storing and transportation requirements,
- Advertising materials that the manufacturer is going to use,
It is also necessary to provide copies of all existing certificates and the valid declaration of conformity.
MDNR or a Medical Device National Registry is a Saudi Arabia national database containing information about all medical devices that are present at the country`s market, and also about all medical device manufacturers, their authorized agents and suppliers, distributors, importers and exporters and other parties involved in operations with medical devices. After the registration, a special number should be assigned. At the same time, such registrations are not an alternative to the marketing authorization and exist separately from the registration performed by the SFDA in the course of basic procedure for all new medical devices. The database is used by the SFDA to obtain additional information about market participants and their compliance with applicable regulations. It also contains information on all medical devices available at the national market and also about all approvals obtained by such devices in other countries.
New Account Opening
First, medical device manufacturers intending to use the new online system must create an account. This requires email and password, and then confirmation of the creation of a new profile. The second step requires additional information about the person that will conduct all operations, including:
- Whether the company is a resident of Saudi Arabia or not,
- The country of residency,
- ID number,
- Full names in English and Arabic,
- Mobile phone number.
The third step requires the manufacturer to create a commercial account for the company itself. There are three types of accounts accepted by the system: Individual, Commercial, and Government. Then it is necessary to upload extended information about the company, such as:
- Terms and conditions,
- Type of investments used by the company (foreign, local or mixed),
- Type of commercial registration (either establishment or the company),
- Commercial registration (CR) number (a copy of an appropriate document shall be attached too),
- Name of the company in English,
- Position of the person submitting the application (the document confirming the authorization to submit the application should be attached too).
At this step, it is also necessary to appoint a particular person responsible for communications with the Authority in the future.
When the account would be created and approved by the authority, the responsible person would get access to the company`s profile in the system. Using the dashboard accessible after logging in, it would be possible to check the status of all valid licenses and submitted applications, including the terms of validity and other important details.
Using the dashboard the responsible person would be also able to submit any type of application related to medical devices.
Global Changes in Medical Device Framework
The implementation of the new system constitutes one of the steps of the general improvement of the whole medical device regulatory framework previously announced by the Authority. For this purpose several important steps would be made, namely:
- Adoption of the entirely new medical device regulations,
- Implementation of the new rules on providing responses to the inquiries of the Authority related to the marketing application.
In the course of this improvement process, the Authority has already introduced new fees for marketing authorization submissions that have increased substantially. The increase is associated with the new approach to the calculation of fees payable. The approach used before was based on the particular class of the device in accordance with the risk-based classification while the new approach provides calculations based on the number of medical devices and accessories in each submission.
The only information available on the new medical device regulation confirms that the most important changes would be associated with the risk-based classification that could be changed substantially. The changes would also impact the reference mechanism allowing to use marketing authorization obtained in other countries to accelerate the authorization procedure in Saudi Arabia – it was announced that such a mechanism would cease to exist.
The new rules on responding to inquiries of the Authority related to the marketing authorization application provide that medical device manufacturers would have to provide a detailed response within the 60 days from receiving the appropriate inquiry. In the case a manufacturer would fail to respond within the specified period of time, the application filed by such manufacturer would be automatically rejected and removed from the system. The new approach is intended to eliminate the delays during the authorization process and accelerate the procedure in general. At the same time, some companies may find difficult to comply with these requirements.
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