CDSCO Import License for Medical Devices In India

 

Central Drugs Standard Control Organisation is, known as CDSCO, is a regulatory body for the Indian medical devices industry, under the vittles of the Drugs & Cosmetics Rules, 1945 and Drugs & Cosmetics Act, 1940. To Import medical device into India is needs to have an import license which is regulated by CDSCO. it’s the national regulatory body for Indian pharmaceutical and medical devices.

Team Operon Strategist will help you in CDSCO Registration or DCGI approval for your products as per the guidelines of CDSCO.

ALL IMPLANTABLE DEVICES, MRI AND CT SCAN EQUIPMENT NOW REQUIRE IMPORT LICENSES 

With the release ofF.No. 29/ Misc/ 03/ 2021- DC( 28) on April 18th, 2021 the Central Drugs Standard Control Organization( CDSCO) now requires the following medical devices gain an Import License previous to importation.

1. All Implantable Medical Devices 
2. CT Scan Equipment 
3. MRI Equipment 
4. Defibrillators 
5. PET Equipment 
6. Dialysis Machines 
7. X-Ray Machines 
8. Bone Marrow Cell Separators 
9. CLASSIFICATION OF MEDICAL DEVICES 

The medical devices are classified into the following 4 orders based on the risk involved in operation 

• Class A – low risk 
• Class B – low to moderate risk 
• Class C – moderate to high risk 
• Class D – high risk 

The devices are further classified into Surgical andNon-Surgical based on their invasiveness.

For more info go through 

CDSCO Import License for Medical Devices In India

CDSCO Manufacturing License for Medical Device

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.

Medical Device Regulatory Consultants

 

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 issues like regulatory compliance, clinical evaluation, and literature searches.  

Key points to consider while choosing the right medical device regulatory consultants /consultancy: 

• Services provided by medical device consultant/consulting firm  
• What does a medical device regulatory consultant do for our project? 
• Need for medical device consultant. 
• How to choose the right medical device regulatory consultant? 
• How much does a medical device consultant cost for his/her services? 
• What do we offer as a medical device consultant? 

Why do we need a medical device regulatory consultants ? 

The first and best answer for this is to avoid rejections.  In short, we need a consultant for easy and hazel free process. When we follow certain regulatory pathways we may face a few obstacles like rejection of application, queries raised by FDA or regulatory bodies can be resolved by consultant. Also, the medical device consultant always has an eye on changing regulations which we aren’t aware of. These professionals prepare technical files of documents like in FDA 510(k) case medical device consultant prepare FDA510(k) dossier or CE mark technical file which helps in the clearance process.  These people also analyze clinical trial data and optimize medical device design & development. 

Read More  - medical device regulatory consultants

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Contact details –

Phone  no -  93702 83428

Mail id – enquiry@operonstrategist.com

If  You Want Medical Devices Services Consultation For Following.

1. Medical Device Consulting 
2. cdsco registration 
3. FDA 510k Clearance 
4. ce mark medical device 
5. CDSCO Manufacturing License 
6. CDSCO import license 
7. TURNKEY PROJECT CONSULTANT 
8. medical device manufacturing 
9. iso 15378 certification 
10. 21 cfr part 210 and 211 
11. ISO 13485 Medical Device Consultant 
12. Primary Packaging Turnkey Project Consultant 
13. Clean Room Design Consultant 
14. manufacturing site conceptualization 
15. Market Analysis and feasibility for Medical Devices 
16. manufacturing plant layout design 
17. medical device design and development 
18. DMF file submission guideline 
19. 21 cfr part 820 
20. qms certification services 
21. capa management 
22. design control requirements 
23. medical device process validation 
24. combination product 
25. continuous improvement program 
26. Medical Device Compliance & Regulatory Services 
27. Cdsco India authorized agent for medical device