SFDA Medical device Registration & regulations

 

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 compliance and efficient regulatory support through 

FDA 510K Submission & Certification for Saudi Arabia

 

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 862.9, 21 CFR 864.9).

The domestic medical device manufacturers from any country trying to introduce a new device to the US market. Re-packers or Re-labellers who make labelling changes or whose operations significantly affect the device.

Operon Strategist is a medical device regulatory consulting company which provides regulatory advisory & guidance to various manufacturers in the healthcare industry to ensure the strategic development of these manufacturers

In Vitro Diagnostic Medical Device Regulation

 

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 section 201(h) of the Federal Food, Drug, and Cosmetic Act, and may also be biological products subject to section 351 of the Public Health Service Act. Like other medical devices, IVDs are subject to premarket and postmarket controls.

CE Marking is required for all in vitro diagnostic (IVD) devices sold in Europe. CE Marking indicates that an IVD device complies with the European In-Vitro Diagnostic Devices Directive (IVDD 98/79/EC) and that the device may be legally commercialized in the EU.

The In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) establishes a new regulatory framework for in vitro diagnostic medical devices, such as HIV tests, pregnancy tests or SARS-CoV-2 tests. It is estimated that around 70% of clinical decisions are made using in vitro diagnostic medical devices.

Thank You!

 

CE Marking Certification for Medical Devices.

 

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 marking Approval consist of few more things such as product quality, technical dossier submission to NB, clinical evaluation and so on. Many medical device manufacturers don’t really read the regulations of EU MDR and they get stuck somewhere in the process, which may delay the project to avoid that you need to know where to start and who is right CE marking consultant for you.  

Operon strategist don’t leave you behind, we make sure that our client should get the CE approval with minimum efforts

In Vitro Diagnostic Medical Device Regulation

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 transition period.