Global market access requires successful device listing, clearance, or approval by various regulatory authorities. Mittal Consulting navigates through regulatory complexly and delivers high quality regulatory documentation to expedite the process of getting your novel products to patients.
Our team supports submissions to a wide range of regulators, including:
United States Food and Drug Administration (FDA)
Mittal Consulting strategically engages with the FDA early in product development to secure actionable feedback that informs device development for streamlined market submissions.
Mittal Consulting supports various FDA premarketing submissions, including:
- Pre-Submission (Q-Submission)
- Pre-Request for Designation (pre-RFD)
- Breakthrough Device Designation
- Total Product Life Cycle Advisory Program (TAP)
Mittal Consulting specializes in gaining market access for novel products.
Mittal Consulting guides FDA submissions at all risk levels, including:
- Listing: For low-risk (Class I) devices
- 510(k) Clearance: For predicated medium-risk (Class II) devices
- De Novo Classification: For novel medium-risk (Class II) devices
- Pre Market Approval (PMA): For high-risk (Class III) devices
European Union- EU MDR
Timely access to the European market requires expert understanding of the regulatory requirements in Europe’s updated Medical Device Regulation. Mittal Consulting optimizes your pathway to CE marking under EU MDR.
Mittal Consulting offers a range of submission support in the European Union, including:
- Education on up-to-date EU MDR requirements and implementation timelines.
- Analysis of EU MDR transition and initial certification planning.
- Preparation of comprehensive Technical Documentation to EU MDR.
Health Canada
Entering the Canadian market necessitates strict adherence to Health Canada’s Medical Device Regulations. Mittal Consulting provides expert assistance in Canadian medical device licensing.
Mittal Consulting supports Health Canada submissions at all risk levels, including:
- Medical Device Establishment Licensing (MDEL): For lowest-risk (Class I) devices
- Medical Device Licensing (MDL): For low-risk (Class II), medium-risk (Class III), high-risk (Class IV), and private label devices
Australia Therapeutic Good Administration (TGA)
Entering the Australian market requires compliance with the TGA’s rigorous regulatory framework. Mittal Consulting provides expert assistance in Australian medical device registration.
Mittal Consulting supports TGA submissions across all classification levels, including:
- Australian Register of Therapeutic Goods (ARTG) Listing:For lowest-risk (Class I) devices
- ARTG Registration: For low-risk (Class IIa), medium-risk (Class IIb), and high-risk (Class III) devices
Brazil Health Regulatory Agency ANVISA
Accessing the Brazilian market demands adherence to ANVISA’s comprehensive regulatory requirements. Mittal Consulting provides specialized support for Brazilian medical device registration.
Mittal Consulting facilitates ANVISA submissions across all risk categories, including:
- Cadastro Registration:For low-risk (Class I) devices
- ANVISA Registration (Registro):For higher-risk (Class II, III, and IV) devices
Japan - Pharmaceuticals and Medical Devices Agency (PMDA)
Entering the Japanese market requires navigating the PMDA’s stringent regulatory pathways. Mittal Consulting delivers expert guidance in Japanese medical device approval.
Mittal Consulting manages PMDA submissions across all classification levels, including:
- Pre-market Certification:For lowest-risk (Class I and some Class II) devices
- Pre-market Approval (Shonin):For low-risk (most Class II), medium-risk (Class III), and high-risk (Class IV) devices
When working with Mittal Consulting, startups and midsize medical device companies receive personalized support and expertise tailored to their unique needs. Our commitment to integrity, innovation, and customer success ensures a smooth regulatory journey, positioning clients for success in the global market.