SFDA Medical Device Packaging, Assembly, And Sterilization Guide

Saudi Food and Drug Authority (SFDA), a government regulatory body, is responsible for ensuring safety and efficacy of medical devices. This regulatory body ensures the medical devices are at par with industry quality benchmark. The main goal of SFDA is to protect public health by strictly regulating and monitoring these devices. Additionally, SFDA is responsible for granting license to medical devices that comply with applicable medical device regulations. Furthermore, it raises consumer awareness regarding medical device safety. The SFDA has formulated stringent regulations for medical devices entering Saudi Arabia. Notably, SFDA regulations consider medical device packaging, assembly, and sterilization as manufacturing activities. Hence, entities involved in packaging, assembly, and sterilization are required to comply with the necessary regulatory requirements. Thus, entities involved in these processes have to apply for an SFDA license for their medical devices.

Securing medical device marketing authorization (MDMA)

Medical device approval issued as Medical Device Marketing Authorization (MDMA) is required to market medical devices in Saudi Arabia. It is the official approval required from SFDA to market your devices in Saudi Arabia. The SFDA medical device registration timeline for the MDMA approval is usually 35 days. Furthermore, the license will remain valid for the period of original license validity or 3 years for undefined original license validity. This official authorisation proves the medical device is deemed safe, effective, and of the required standard. It ensures the medical device manufacturers comply with the SFDA regulations governing medical devices. As SFDA considers medical device packaging, assembly, and sterilization as manufacturing activities, those involved in these processes will have to secure the SFDA license for medical devices.

4 key points regarding MDMA

1. Authorized representative: Manufacturers not having any local presence in Saudi Arabia need to appoint an authorised representative. The representative will act as a liaison between the SFDA officials and foreign manufacturer. The representative will be responsible for all regulatory matters as well as will submit the license application on behalf of the manufacturer.
2. Correct device classification: Medical devices are categorised into different classes depending on the associated risk level. It is crucial to correctly classify the medical device, as the SFDA medical device class will determine the license requirements.
3. Technical file preparation: A comprehensive technical file containing device specifications, safety data, and clinical evaluation reports has to be prepared. This file is required to demonstrate the device’s safety, performance, and compliance with regulations. 
4. SFDA review: The SFDA will meticulously review the license application, ensuring the device meets all regulatory requirements. They will ensure the manufacturer’s quality management system complies with international standards, such as ISO 13485. Furthermore, they will check whether the medical device packaging, assembly, and sterilization processes meet SFDA’s safety, quality, and efficacy standards. 

Medical device packaging, assembly, and sterilization: SFDA regulatory guidelines

The SFDA has laid down guidelines for medical device packaging, assembly, and sterilization. The key regulatory aspects are as follows:

• Medical device packaging requirements: Medical devices have to be appropriately packaged to protect them from contamination and damage during storage and transportation of the devices. Thus, SFDA guidelines dictate packaging material standards, labelling requirements, and validation procedures to ensure compliance with guidelines. Additionally, the medical device packaging process should comply with ISO 11607-1 and ISO 11607-2 guidelines. These guidelines focus on packaging system validation for terminally sterilized medical devices. 
• Medical device assembly guidelines: The medical devices should be assembled per Good Manufacturing Practices (GMP) guidelines. Additionally, they should be assembled in a controlled environment to prevent defects or contamination. Furthermore, compliance with ISO 13485 guidelines ensures the quality management system is maintained and consistent throughout the assembly process. 
• Medical device sterilization standards: SFDA has implemented strict medical device sterilization standards. It requires manufacturers to use validated methods, such as ethylene oxide (EtO), gamma radiation, or steam sterilization. Additionally, the sterilization process must comply with international standards, such as ISO 11135 for EtO sterilization, ISO 11137 for radiation sterilization, and ISO 17665 for moist heat sterilization. 

Furthermore, the SFDA guidelines require these processes to be carried out in a controlled environment to maintain product integrity and ensure patient safety. Moreover, documentation and validation reports have to be submitted to demonstrate compliance with SFDA regulatory requirements.

How will we help you comply with SFDA medical device packaging, assembly, and sterilization guidelines?

We at Pharmadocx Consultants are committed to help our clients comply with SFDA medical device packaging, assembly, and sterilization guidelines in a hassle-free manner. We provide end-to-end solutions for easily obtaining SFDA approval, thereby ensuring seamless market entry. Moreover, we help our clients easily navigate the SFDA regulatory requirements and guidelines.

• Technology transfer: We will help seamlessly transfer advanced manufacturing, packaging, and sterilization technologies between two entities. Additionally, we will ensure compliance with SFDA regulations at every step.
• Material sourcing: Our team will assist you in identifying trusted partners for procuring high-quality materials and components that meet global product quality standards. 
• Packaging and assembly support: We will guide you through the packaging and assembly process as well as help you optimize them. Additionally, we will ensure each step in the packaging and assembly process is as per SFDA guidelines. Furthermore, we will help you validate the whole procedure to demonstrate compliance.
• Sterilization process regulatory compliance: Medical device sterilization process has extensive regulatory requirements. Our team will help you adhere to the SFDA sterilization requirements, including validation and documentation guidelines for sterilization. 
• MDMA registration assistance: We help manufacturers prepare and submit the application for SFDA approval. Additionally, we will help you prepare and compile the necessary supporting documents. We provide comprehensive MDMA registration assistance to our clients planning to enter the Saudi Arabia medical device market.

Pharmadocx Consultants: Your trusted SFDA regulatory support

We provide all-encompassing SFDA regulatory support. Here’s why you should opt for our service:

• Expertise in SFDA regulatory guidelines: Our team is well-versed with SFDA regulatory guidelines and requirements. Notably, medical device packaging, assembly, and sterilization processes are also regulated by the SFDA. Hence, these processes also require entities to secure SFDA license and approval. We will ensure that your application aligns perfectly with the regulatory requirements, increasing the chances of swift approval.
• Document Preparation and Review: With our in-depth knowledge of the required documentation, we provide thorough assistance with document preparation. Our team will help compile and prepare the necessary supporting documents for license application.
• Cost-Effective Solutions: We offer competitive pricing ensuring you get the best regulatory services at a reasonable cost.
• Client-Centric Approach: Our clients are our top priority. We understand each client has unique business and regulatory requirements. Hence, we tailor our services to meet your specific needs, ensuring a personalized experience.
• Regular Updates: We provide regular updates on the status of your license application, ensuring you are always on the loop.
• End-to-End Assistance: From license application to license approval, we are with you in every step of the journey. Our support does not stop with license application. We will work tirelessly to help you secure the license.
• Post-License Support: Our relationship does not end with the license approval. We offer post-license support. SFDA regulatory guidelines are dynamic and are constantly updated. Our team will provide ongoing support for compliance with latest and updated guidelines. Additionally, we provide license renewal support.

Need help navigating SFDA medical device packaging, assembly, and sterilization guidelines. Shoot your query or requirements to [email protected] or call/Whatsapp on 9996859227. Our team will be more than happy to help you with your SFDA regulatory needs.