Saudi Arabia is evolving as growing market for healthcare sector, there are huge opportunities which are attracting to medical device manufacturers. Medical device manufacturers need to register their device with SFDA and obtain a certificate from MDMA (Medical Device Market Authorization) as per the MDIR (Medical Device Interim Regulations) Saudi Arabia. MDMA is needed for high-risk devices whereas low risk devices (non- sterile, non-measuring) don’t require prolonged MDMA. If you are a new manufacturer or already active commercially, we Team of Operon Strategist ensure compl ..read more

  Determining whether you need FDA 510k or PMA for your medical device will depend on the classification of your device. Every device manufacturer who wishes to trade in the US market needs to classify their medical device as Class I, II, and III. Premarket approval application (PMA) is not necessary if those are meant to human use, but must submit FDA 510 (k) unless the device is exempt from 510 (k) necessity of the Federal Food, Drugs and Cosmetic Act (the FD&C Act), and does not overreach the circumstance of exemptions of the device classification regulation chapters (e.g., 21 CFR ..read more

  IVDR stands for In Vitro Diagnostic Regulation. IVDR is a risk-based approach to classify device with increased notified body and competent authority controls. The Regulation identifies four risk classes: ·       Class A (lowest risk), ·       Class B, ·       Class C, and ·       Class D (highest risk)   while Annex VIII define seven classification rules to correctly classify the products.   Regulatory Authority: IVDs are devices as defined in sect ..read more

  CE certification is required for medical devices to demonstrate that your medical device meets the requirements of the Medical Device manufacturer by carrying out a conformity assessment. It depends on the classification of medical device. The steps for CE certification process for medical devices is as follows:  ·   Classification  ·   Applicable directive  ·   Technical documentation   ·   Certification.  CE mark Approval process will vary according to the Class of medical device, as per the MDR CE m ..read more

IVDR stands for In Vitro Diagnostic Regulation. IVDR is a risk-based approach to classify device with increased notified body and competent authority controls. The Regulation identifies four risk classes: ·       Class A (lowest risk), ·       Class B, ·       Class C, and ·       Class D (highest risk) The In Vitro Diagnostic Medical Device Regulation has progressively roll out from May 26 ,2022. The IVDR strengthens the existing regulatory framework providing a 5-year ..read more

  Medical device consultancies or the regulatory consultants are highly experienced professionals from healthcare industries. With rapid positive growth  in medical science, the medical device industry is coming up with more and more advanced devices. But launching a new product on the market is not easy. The devices should comply with all the regulatory bodies. For this reason, many companies hire a medical device regulatory  consultant, who helps them through the complex process of bringing their medical device into the market. These professional guide through many issu ..read more

  Notified Bodies an overview:  A Notified Body is a third-party organization that has been approved by an EU member state to judge whether manufacturers adhere to the relevant legislation. With such a crucial role, choosing a Notified Body and your partnership’s working relationship are crucial to getting your CE marking. As CE marking medical device consultant, we know the criticality of selecting the Notified body and hence we work with right notified bodies to get the compliance.  Selection of a Notified Body and their Process:  Not only medical device ..read more

If the medical device is manufactured outside of the European Union, the CE marking provides access to European markets for products. Before putting the product on the market in the European Economic Area, the manufacturer shall be required to get and display the CE mark on the product (EEA). This responsibility shifts to the importer if the medical device is brought in from outside the EEA. The abbreviation “CE” stands for “European Conformity,” which is the English translation of the French word “Conformité Européene.  Since ISO 13485 is in line with European medical device directive ..read more

  SUGAM is a single window interface to access online services offered by CDSCO. This portal allows users to update and upload data on their website related to license of drugs & medical device manufacturing facilities in India. SUGAM portal is a single window interface. To apply for any form user, you need to register on the portal first. The comprehensive database of SUGAM portal includes details of manufacturer, manufacturing site etc. The applications which are submitted on SUGAM online portal are approved/rejected by CDSCO. For the registration process applicants need to submit ..read more

A FDA 510k clearance or premarket submission demonstrates that the device which is marketed is safe and effective as predicate. The FDA 510k process is necessary to enter into the US market / or to sell your device in the US market. The FDA is responsible for authoring and enforcing the medical device quality system regulations (QSR), found in 21 CFR Part 820 of the Code of Federal Regulations. The FDA 510 k clearance process is the most common pre-market pathway for medical device companies.  There are certain reasons due to which the 510k process gets delayed or the FD ..read more