MDS – G11 Guidance on Manufacturing Paths of Medical Devices Version Number: 2.0 Version Date: 7/7/2025 “Translated Copy” MDS-G-011-V2/250707 Page 1 of 12 MDS-G-011-V2/250707
Table of Content Introduction _____________________________________________________________ 3 Purpose _____________________________________________________________ 3 Scope _______________________________________________________________ 3 Background __________________________________________________________ 3 Requirements ____________________________________________________________ 4 Annexes ________________________________________________________________ 6 Annex (1): Manufacturing Paths and Marketing Authorization __________________ 7 Annex (2): Definitions & Abbreviations ___________________________________ 10 Annex (3): List of Changes in the Previous Version __________________________ 12 Page 2 of 12 MDS-G-011-V2/250707
Introduction Purpose The purpose of this document is to clarify the manufacturing paths for medical devices within the KSA (including the transfer and localization of their technology) and the associated marketing authorization procedures, as well as addressing requirements for circulation, and import for manufacturing purposes, and obtaining a certificate of free sale for export. Scope This document applies to manufacturers of medical devices who perform design and manufacturing (including refurbishing, assembling, packaging, labeling, and placing identifying information) within the KSA. Background SFDA has issued this document: − in reference to the ‘Law of Medical Devices’ issued by the Royal Decree No. (M/54) dated 6/7/1442 H, and it Implementing Regulation issued by Saudi Food and Drug Authority Board of Directors decree No. (3-29-1443) dated 19/2/1443H. − in support of the following “National Strategy for Industry” initiatives: Providing technical and commercial support to manufacturers of medical devices. Providing supporting for local supply chain development to enhance localization and ability for complying with regulations. Page 3 of 12 MDS-G-011-V2/250707
Requirements General 1 Manufacturer and medical devices are subject to the provisions of the “Law of Medical Devices" and its Implementing Regulation. Manufacturing 2 For manufacturing medical devices, the manufacturer shall obtain a medical device manufacturer license, see (MDS-REQ9). Note: One of the license requirements is obtaining a QMS certificate in accordance with ISO 13485:2016, or the latest edition if adopted by the SFDA, from one of SFDA-accredited CABs, see (MDS- REQ9) and (MDS-REQ10). Manufacturing 3 For the circulation of medical devices, the MDMA certificate shall Paths and be obtained, see (MDS-REQ1) , and see the manufacturing paths in MDMA Annex (1). Notes: − The SFDA grants the MDMA certificate in the name of the manufacturer. − MDMA Requirements are harmonized with international regulations. − The SFDA shall be notified of any significant or non- significant changes to the information provided for the purpose of obtaining MDMA, in accordance with the Guidance on significant and non-Significant changes (MDS-G12). − Devices intended for clinical investigations, research, education, demonstration, training, custom-made purposes, or use in national emergency are exempted from the MDMA (see MDS-REQ5). Importintion 4 For importing semi-finished medical devices for the purpose of manufacturing them within the KSA and subsequently obtaining the MDMA (after manufacturing), an import permit shall be obtained, see (MDS-REQ5). Free Sale 5 For obtaining a Free Sale Certificate for the manufacturer , the Certificate application may be submitted in accordance with the requirements specified in (MDS-REQ5). Note: The following are among the requirements for obtaining the certificate − MDMA, see Section (3) above. − Manufacturer License , see Section (2) above. Page 4 of 12 MDS-G-011-V2/250707
Technical 6 The SFDA provides technical support to manufacturers, free of Support charge, to clarify the regulatory and technical requirements for manufacturer licensing and obtaining MDMA. The support can be obtained via: − Calling SFDA call center (19999). − Sending an e-mail to the “product registration support section” at md.rs@sfda.gov.sa. − Meeting with SFDA technical team. − Attending relevant workshops. Page 5 of 12 MDS-G-011-V2/250707
Annexes Page 6 of 12 MDS-G-011-V2/250707
Annex (1): Manufacturing Paths for Manufacturers within the KSA and MDMA Procedure Path 1 Path 2 Path 3 Manufacturing (Full Manufacturing) (Manufacturing at the (Contract Paths Manufacturer’s Manufacturing with Sites/Branches) Third Parties) Performing all Performing part of the Performing part of the processes¹ at a single processes¹ at a processes¹ at a manufacturer site manufacturer site manufacturer site located within the located within the located within the KSA. KSA, while the other KSA, while the other part is carried out by part is carried out by an another site either independent inside or outside the manufacturer located KSA. outside the KSA, under a contract between the two manufacturers. MDMA Procedure Additionally, the manufacturer located within the KSA sources one of the product components from an independent manufacturer/supplier located outside the KSA. The manufacturer It is the manufacturer It is the manufacturer It is the manufacturer responsible for itself. that places the product that places the product submitting the for use under its name for use under its name MDMA application and is legally and is legally responsible for it. responsible for it. Note: If the Note: If the manufacturer manufacturer responsible for responsible for submitting the MDMA submitting the MDMA application is located application is located outside the KSA, refer outside the KSA, refer to Note (2) to Note (2) Page 7 of 12 MDS-G-011-V2/250707
Manufacturers’ QMS The certificate shall be A separate certificate An independent certificate submitted. shall be submitted for certificate shall be each branch/site of the submitted for each manufacturer that manufacturer, along performed any part of with a quality the processes¹, assurance agreement or a single certificate between the covering all parts of the contracting processes¹ performed manufacturers. by the manufacturer and its relevant branches/site. Note: The certificate Note: The certificate Note: The certificate shall cover all shall cover the shall cover the processes.¹ processes¹ carried out processes¹ carried out by each manufacturer. by each manufacturer. Product Labelling It shall bear the name It shall bear the name It shall bear the name and address of the and address of the and address of the manufacturer manufacturer manufacturer responsible for responsible for responsible for submitting the submitting the submitting the application (legal application (legal application (legal manufacturer), manufacturer), manufacturer), along along with the symbol along with the symbol.² with the symbol.² next to it.² It is permissible to add It is permissible to add the branch/site address, the name and address as well as the process¹ of another performed, such as manufacturer. "Assembled in [manufacturer’s name]". Technical All technical documentation of the product related Documentations to all processes¹ shall be submitted. Notes 1. If all manufacturing processes are conducted outside the KSA (with no process taking place within the KSA), and the product is imported in its final form, the manufacturing pathways described in this document do not apply. Only one of the following two cases shall apply: a) If the product will be placed for use under the name of the importing establishment, which holds legal responsibility: − This establishment is considered the manufacturer responsible for submitting the MDMA application (legal manufacturer), and shall provide all relevant details and technical documentation showing the design and manufacturing processes, along with the Page 8 of 12 MDS-G-011-V2/250707
agreements signed between both parties (including the quality assurance agreement). − The labelling shall include the name and address of this establishment (legal manufacturer), along with the symbol.² − The labelling shall state the following: The phrase “Manufacturer for”, and the phrase “Manufactured by” can also be stated. The country of manufacture. b) If the product will not be placed for use under the name of the importing establishment (e.g., when an establishment that does not carry out any of the manufacturing processes agreement with a manufacturer — for whom it is not legally responsible — to label the product as “Manufactured for [name of the establishment]”): − This establishment is not considered a manufacturer. − The technical documentation shall be submitted by the overseas manufacturer or its AR. − The labelling shall include the name and address of the legal manufacturer, along with the symbol.² 2. If the manufacturer responsible for submitting the application (legal manufacturer) is located outside the KSA, an AR shall be appointed. The manufacturer may choose one of the following options: a) Submit the application directly (by creating an overseas manufacturer account in the GHAD system, and the AR will not have access to the product’s technical documentation). b) Granting its AR the authority to submit the application on its behalf. ¹ Product design and manufacturing processes (manufacturing includes: assembling, packaging, refurbishing and labelling) ² The symbol is used where appropriate and in accordance with the standard "Medical devices — Symbols to be used with information to be supplied by the manufactur— Part 1: General requirements (SFDA.MD/ISO 15223-1)". Page 9 of 12 MDS-G-011-V2/250707
Annex (2): Definitions & Abbreviations KSA Kingdom of Saudi Arabia SFDA Saudi Food and Drug Authority Law Law of Medical Devices CABs Conformity Assessment Bodies Medical Device Any instrument, apparatus, implement, implant device, in vitro reagent or calibrator, software, or material used for operating medical devices, or any other similar or related article, intended to be used alone or in combination with other devices for diagnosis, prevention, monitoring, controlling, treatment, or alleviation of disease or injury, or for compensation for an injury; investigation, replacement, modification, or support of the anatomy or of a physiological process; supporting or sustaining life; controlling or assisting conception; sterilization of medical devices ; providing information for medical or personal purposes by means of in vitro examination of specimens derived from the human body; and does not achieve its primary intended action by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means Medical Supply A medical substance or product used in diagnosis, treatment, prosthetics, or orthotics; or in disability cases or other medical uses for humans, including medical gases. Manufacturer Any national or foreign establishment the purposes of which include designing or manufacturing medical devices for use under its name within the Kingdom or abroad. Manufacturing shall include refurbishing, assembling, packaging, and labelling. Authorized A legal person based in the Kingdom who has written Representative (AR) authorization from a manufacturer located outside the Kingdom to represent it in the Kingdom with regard to the implementation of this Law and its Regulations. Distributer An establishment in the supply chain that supplies the medical device to another distributor or end user. Circulation of Medical The provision of medical devices at no cost or for a fee, whether Devices for distribution or use. Marketing A document issued by the SFDA permitting the circulation of a Authorization medical device in the market. (MDMA) Quality Management A system approved by the SFDA to verify the quality, System (QMS) effectiveness, and safety of a medical device in accordance with the latest edition of the Technical Standard (ISO 13485) or its equivalent, as provided in the Regulations. Page 10 of 12 MDS-G-011-V2/250707
Identifying Any statement, information, or illustration printed on a medical Information (Labeling) device, including identifying information, technical description, method of use, and manner of storage and transportation. Technical Technical and scientific documentation and information related to Documentation the medical device and Manufacturer, including documented and approved procedures, which prove that the medical device conforms to the safety, efficacy, and quality requirements specified in the Law and its Regulation. Qality Assurance Document between the manufacturer submitting the application Agreement (the Legal Manufacturer) and the contracted manufacturer, which obligates the contracted manufacturer to manufacture in accordance with the specifications and regulatory requirements previously defined by the Legal Manufacturer. Page 11 of 12 MDS-G-011-V2/250707
Annex (3): List of Changes in the Previous Version Number and Date of the Changes Description Previous Version 1.0 − Rearranging the "Requirements". 22/3/2023 − Adding notes in paragraph (3): Manufacturing pathways and MDMA. − Adding definitions (Quality Assurance Agreement, Full Manufacturing, Contract Manufacturing). − Changing to the pathways in Annex (1). Page 12 of 12 MDS-G-011-V2/250707
