Online Training - Medical Devices Regulatory Affairs with Experience Certification & Placement Assistance
BioMed Informatics Medwin Hospitals, Hyderabad, India is a leading Clinical Research Organization offering best Medical Devices Regulatory Affairs Training in Hyderabad since the year of 2000. Online Medical Devices Regulatory Affairs Training in Hyderabad, India includes best Regulatory Affairs Training in Medical Devices online Institute that imparts knowledge about Medical Device Regulations. Medical Devices Regulatory Affairs certificate course is valuable for professionals to scale up their career. BioMed Informatics Medwin Hospitals Online Training complimented as the best Medical Devices Regulatory Affairs Training in USA, best Medical Devices Regulatory Affairs Training in UK, best Medical Devices Regulatory Affairs Training in Australia, best Medical Devices Regulatory Affairs Training in Germany, best Medical Devices Regulatory Affairs Training in Sweden, best Medical Devices Regulatory Affairs Training in Netherlands, best Medical Devices Regulatory Affairs Training in Singapore, best Medical Devices Regulatory Affairs Training in Europe, best Medical Devices Regulatory Affairs Training in Canada. Training in Online Regulatory Affairs in Medical Devices is very much helpful for the professionals planning to switch over their jobs or even for fresh jobs too. With the rising innovations and the rapid growth in healthcare sector, the demand for Medical Devices Regulatory Affairs Professionals has been increased.
Medical Devices Regulatory Affairs professionals are the link between Medical Devices industries and worldwide regulatory agencies like USA, UK, Canada, European Union, India, Japan, Australia. Healthcare industry, being one of the highly regulated industries, is in immense need of people than ever before who are capable of handling issues related to regulatory affairs in a comprehensive manner. Regulatory affairs professionals play an essential role in ensuring all Medical Devices comply with regulations governing the industry. Regulatory professionals employed in industry are involved with a wide range of medical devices made in various countries. As regulatory processes increase in complexity and scope, and globalization occurs within the field, there will be continuing industry demand for people with a strong foundation in Medical Devices regulatory affairs. The Regulatory Affairs program provides professionals with the specialized knowledge required to help biotechnology, medical device, pharmaceutical and food companies manage regulatory processes.
Online Training Features
- Web based classroom
- One faculty/student
- Placement support
- Regular/Fast track/Weekend individual slot
- Flexible timings
- Training Mode: Skype/Teamviewer
Certification
Course Certificate & Job Experience Certificate would be awarded at the end of the program.
Course Curriculum
- Medical Devices Regulatory Affairs - MDRA
- Overview of Regulatory Requirements : Medical Devices
- FDA / CDRH Functioning
- Medical Device Classification
- Devices / Device Panels / Regulation Product Codes
- 21 CFR Parts 800-1299
- Product Classification Database : 21 CFR Parts 862-892
- Distinct Product Code Identification Procedure
- Total Product Life Cycle (TPCL) / TPCL Product Code Report
- General controls and Special controls
- Pre-market approval – PMA
- Adulteration
- Misbranding
- Electronic Establishment Registration
- Pre-market notification submission 510(k)
- 510(k) Marketing clearance process
- Medical Device Exemptions 510(k)
- FDA Clearance
- Medical Device Reporting – MDR
- Special labeling
- Establishment Registration and Medical Device Listing
- Reserve Devices
- Special 510(k)
- Abbreviated 510(k)
- Substantial equivalence
- Medical device labeling
- Post-market studies
- Medical device tracking
- Comparative Study :
- Medical Device Regulations in USA
- Medical Device Regulations in European Union
- Medical Device Regulations in India
Global Medical Devices Regulatory Affairs (MDRA) Regulations
Medical Devices Regulatory Affairs (MDRA) involves ensuring medical devices meet the requirements of regulatory authorities globally. This ensures safety, efficacy, and compliance with national and international standards. Below is an overview of the key regulations and regulatory bodies for medical devices worldwide:
Oceania
Australia
- Regulatory Body: Therapeutic Goods Administration (TGA)
- Regulations:
- Therapeutic Goods Act 1989 governs medical device registration.
- Devices are classified (Class I, IIa, IIb, III) based on risk.
- Compliance with ISO 13485 and conformity assessment is mandatory.
New Zealand
- Regulatory Body: MEDSAFE
- Regulations:
- Follows a risk-based classification system similar to Australia.
- Alignment with international standards (ISO 13485, IEC 60601).
North America
United States
- Regulatory Body: Food and Drug Administration (FDA)
- Regulations:
- 21 CFR Part 807: Registration and device listing.
- 21 CFR Part 820: Quality System Regulation (QSR).
- Premarket submissions required (510(k), PMA, De Novo).
Canada
- Regulatory Body: Health Canada
- Regulations:
- Medical Devices Regulations (SOR/98-282) under the Food and Drugs Act.
- Devices are classified as Class I-IV based on risk.
- ISO 13485 certification is required for licensing.
Central/South America
Brazil
- Regulatory Body: ANVISA (AgenciaNacional de Vigilancia Sanitaria)
- Regulations:
- Devices classified by risk (Class I-IV).
- Compliance with RDC 185/2001 and ISO 13485 required.
Mexico
- Regulatory Body: COFEPRIS
- Regulations:
- Devices classified by risk (Class I-III).
- Registration based on product type and intended use.
Europe
European Union
- Regulatory Body: European Medicines Agency (EMA)
- Regulations:
- EU MDR 2017/745: Medical Device Regulation for CE marking.
- Devices classified as Class I, IIa, IIb, III based on risk.
- Conformity assessment by Notified Bodies.
United Kingdom
- Regulatory Body: Medicines and Healthcare products Regulatory Agency (MHRA)
- Regulations:
- UKCA marking.
- Regulations align with EU MDR with modifications.
Asia
India
- Regulatory Body: Central Drugs Standard Control Organization (CDSCO)
- Regulations:
- Medical Devices Rules, 2017.
- Devices classified (A-D) based on risk.
- ISO 13485 compliance is mandatory.
China
- Regulatory Body: National Medical Products Administration (NMPA)
- Regulations:
- Registration of Class I-III devices.
- GB standards apply, alongside ISO 13485.
Japan
- Regulatory Body: Pharmaceuticals and Medical Devices Agency (PMDA)
- Regulations:
- Pharmaceuticals and Medical Devices Act (PMD Act).
- Devices classified (Class I-IV).
- QMS based on ISO 13485 is required.
Middle East
Saudi Arabia
- Regulatory Body: Saudi Food and Drug Authority (SFDA)
- Regulations:
- Devices must be registered under the Medical Devices Interim Regulation.
- ISO 13485 compliance required.
United Arab Emirates
- Regulatory Body: Ministry of Health
- Regulations:
- Adheres to international standards for device approval.
Africa
South Africa
- Regulatory Body: South African Health Products Regulatory Authority (SAHPRA)
- Regulations:
- Risk-based classification (Class A-D).
- ISO 13485 compliance required for registration.
Nigeria
- Regulatory Body: National Agency for Food and Drug Administration and Control
- NAFDAC
- Regulations:
- Registration based on risk classification.
Global Medical Devices Regulatory Affairs (MDRA) Salaries
Salaries for professionals in Medical Devices Regulatory Affairs (MDRA) vary significantly depending on geography, experience, and the size of the organization. Below is an overview of typical salary ranges globally:
North America
USA:
- Entry-level: $65,000–$85,000/year
- Mid-level: $90,000–$130,000/year
- Senior-level: $140,000–$200,000/year
Canada:
- Entry-level: CAD 55,000–CAD 80,000/year
- Mid-level: CAD 85,000–CAD 120,000/year
- Senior-level: CAD 130,000–CAD 180,000+/year
Europe
United Kingdom:
- Entry-level: £30,000–£45,000/year
- Mid-level: £50,000–£80,000/year
- Senior-level: £90,000–£150,000/year
Germany/France/Netherlands:
- Entry-level: €35,000–€50,000/year
- Mid-level: €55,000–€85,000/year
- Senior-level: €90,000–€140,000/year
Asia-Pacific
India:
- Entry-level: ₹6,00,000–₹10,00,000/year
- Mid-level: ₹12,00,000–₹20,00,000/year
- Senior-level: ₹25,00,000–₹40,00,000+/year
Japan:
- Entry-level: ¥5,000,000–¥8,000,000/year
- Mid-level: ¥9,000,000–¥15,000,000/year
- Senior-level: ¥16,000,000–¥25,000,000+/year
Australia:
- Entry-level: AUD 60,000–AUD 85,000/year
- Mid-level: AUD 90,000–AUD 130,000/year
- Senior-level: AUD 140,000–AUD 200,000+/year
Middle East
UAE:
- Entry-level: AED 150,000–AED 200,000/year
- Mid-level: AED 210,000–AED 300,000/year
- Senior-level: AED 350,000–AED 500,000/year
Saudi Arabia:
- Entry-level: SAR 120,000–SAR 180,000/year
- Mid-level: SAR 200,000–SAR 300,000/year
- Senior-level: SAR 350,000–SAR 500,000/year
Africa
South Africa:
- Entry-level: ZAR 350,000–ZAR 500,000/year
- Mid-level: ZAR 550,000–ZAR 850,000/year
- Senior-level: ZAR 1,000,000–ZAR 1,500,000/year
Nigeria/Kenya/Ghana
- Entry-level: $20,000–$30,000/year
- Mid-level: $35,000–$50,000/year
- Senior-level: $60,000–$100,000/year