Want to Break into the Lucrative Indian Medical Device Market?

Aspect	USA	EU	Australia	China	India
Regulatory Authority	FDA (U.S. Food and Drug Administration)	EFSA (European Food Safety Authority) & European Commission	FSANZ (Food Standards Australia New Zealand)	SAMR (State Administration for Market Regulation)	FSSAI (Food Safety and Standards Authority of India)
Major Regulation Governing Compliance	21 CFR Part 106 & 107 – Infant Formula Regulations	Regulation (EU) No 609/2013 on Foods for Specific Groups (FSG)	Australia New Zealand Food Standards Code	GB Standards (e.g., GB 10765-2021) for infant formula	Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2019
Pre-market Approval Required?	Yes – Manufacturer registration and notification	Yes – Pre-market notification and composition review	No – Comply with standards, but no pre-approval	Yes – Mandatory registration with SAMR	Yes – Prior approval and product registration required
Labeling Requirements	Must meet strict CFS 21 Part 107 labeling and nutritional information requirements for infant formula.	Must comply with harmonized EU labeling rules, including allergens, nutrition info	Must comply with FSANZ labeling codes	Must follow GB labeling standards, including mandatory warnings	Must follow specific infant food labeling rules under FSSAI
Nutritional Composition Requirements	Specific nutrient content, quality control & Good Manufacturing Practices (GMP) required	Detailed compositional criteria for energy, protein, vitamins, and minerals	Must meet nutrition content standards specified by FSANZ	Stringent GB compositional standards; new updates in 2021	As per Schedules under FSSAI regulations, modeled on Codex guidelines
Claims Allowed	Limited; FDA approval required for structure-function or health claims	Only EU-authorized claims permitted; No health or nutritional claims on infant formula	Functional and nutrient claims allowed within Regulatory limits	Strict control; health/nutritional claims require SAMR review	Only pre-approved nutrition claims allowed; therapeutic claims not permitted
Clinical Evidence Required?	Yes – Especially for new formulations or ingredients	Yes – EFSA scientific dossier for novel ingredients or composition	Required for novel ingredients or changes in nutrient bioavailability	Yes – For new products or ingredient combinations	Yes – If deviating from standard composition or for novel formulations
Timeline for Registration	~6–12 months, depending on product review	~12–18 months, including EFSA evaluation	~3–6 months for market entry if compliant	~18–24 months, including safety and technical review	~12–18 months for full Regulatory clearance
Need for Local Representative	Yes	Yes	No	Yes	Yes

Accelerate your CDSCO registration process with Freyr Solutions — your trusted partner for navigating India's complex medical device Regulatory landscape.

Hassle-free compliance with local Regulatory bodies
Fast-tracked approvals for import, manufacturing, and market entry
Minimized documentation delays for seamless submissions

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Expert Regulatory Professionals

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Successful Medical Device Registrations Globally

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CDSCO Device Approvals in India

Proven Success Story

Seamless CDSCO Compliance for IVD Products: A Proven Success Story

Discover how Freyr Solutions helped a leading US-based manufacturer achieve market entry with

28 IVD Products Approved by CDSCO
Approval secured within just 6 months
Minimal additional information requests from CDSCO

Read the Full Success Story

Freyr India Medical Devices Compliance Services

Due diligence Report and Regulatory Strategy
Regulatory Intelligence Report for the Indian market
Device Classification and grouping strategy
Device Listing
Device Registration (Manufacturing License and Import License)
- Gap Assessment of device technical documents
- Compilation of Device Master File (DMF)
- Manufacturing Site Registration
- Submission of Application along with the Supporting documents
- Query Addressal and support till approval
SUGAM account creation and account management
Indian Authorized Agent Services
- Annual Indian Registration Agent (IAA)
- Transfer of Indian Authorized Agent (IAA)
Post-approval device life cycle management
Labeling Services
- Labeling review for CDSCO compliance.
- Liaison with CDSCO, centra/ and State Licensing Authorities
- In-country testing services

Explore Freyr’s all-inclusive India Medical Devices services and ensure smooth Regulatory compliance.

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Why Partner with Freyr?

Comprehensive Support
From pre-submission to post-approval
99% Right-First-Time Accuracy
Save time and resources
India-Specific Expertise
Deep understanding of Indian regulations
Seamless IAA Management
Trusted local representation

Frequently Asked Questions

1. How can I obtain a CDSCO import license for medical devices in India?

Manufacturers must submit technical dossiers, clinical data, and device details via an Indian Authorized Agent. Freyr handles the complete application process.

2. What is the process for CDSCO medical device registration?

The process includes device classification, technical dossier preparation, and SUGAM portal submission to comply with India’s Medical Device Rules (MDR).

3.How long does CDSCO approval take?

Timelines depend on device classification and submission accuracy. Import license approvals typically take 9 months if documentation is complete.

4. Can US FDA-approved devices gain fast-track CDSCO approval?

Yes, if the device has been marketed in the US for at least 2 years and meets CDSCO safety criteria. Freyr evaluates eligibility and expedites approval.

Contact our CDSCO Experts Now!

Aspect	USA	EU	Australia	China	UAE
Regulatory Authority	FDA	EFSA & Member State Authorities	FSANZ	SAMR & NHC	ESMA & MOHAP
Major Regulation Governing Compliance	Federal Food, Drug, and Cosmetic Act (FFDCA); 21 CFR Part 110 (Current Good Manufacturing Practices)	Regulation (EC) No 178/2002 (General Food Law); Regulation (EU) No 1169/2011 on Food Information to Consumers	Food Standards Code (Australia New Zealand Food Standards Code)	Food Safety Law of the People's Republic of China (Revised 2015); GB Standards for Food Safety	UAE.S GSO 9:2017 (GCC General Requirements for Prepackaged Food)
Pre-market Approval Required?	No pre-market approval except for novel ingredients, color additives, or specific claims	No pre-market approval for general foods, but novel foods or health claims require EFSA approval.	No pre-market approval unless it's a novel food or makes health claims	Pre-market registration is required for novel foods, health foods, or products with new ingredients	Pre-market approval is required for certain foods, health products, and products with new ingredients
Processed Food Labeling Compliance /Labeling Requirements	Mandatory labeling as per FDA guidelines (Nutrition Facts, Ingredient Declaration, Allergens)	Must comply with EU Food Information Regulation (1169/2011); includes allergens, nutrition, and origin labeling.	Must follow FSANZ Food Standards Code for labeling; nutrition panels, allergens, and ingredient lists required	Must follow GB 7718-2011 (National Food Safety Standards) for labeling; mandatory nutrition facts, allergens, and shelf-life	Must follow GSO 9:2017 for pre-packaged food labeling; Arabic labeling, allergens, and nutrition facts required
Timeline for Registration	No fixed timeline: products can enter the market once compliant	No formal registration unless novel food; EFSA approval for health claims takes 12-18 months	No formal registration unless it's a novel food or makes health claims	Typically, 12-24 months for novel foods, shorter for regular processed foods	Approval may take 6-12 months for certain products. Regular processed foods can enter the market once label approval is obtained

Aspect	USA	EU	Australia	India	UAE
Regulatory Authority	FDA Center for Tobacco Products (CTP) / CDER	EC / Member States	TGA / FSANZ	Ministry of Health and Family Welfare and National Tobacco Control Cell (NTCC)	ESMA / MOHAP
Major Regulation Governing Compliance	Family Smoking Prevention and Tobacco Control Act (TCA);	Tobacco Products Directive 2014/40/EU (TPD); Novel Food Regulation	Therapeutic Goods Act 1989; Tobacco and Nicotine legislation; (Therapeutic Goods Standards for Nicotine and Therapeutic Vaping Products – TGO 110)	Food Safety and Standards Act (COTPA, 2003 and 2023 Amendment Rules; Prohibition of Electronic Cigarettes Act, 2019)	UAE Federal Law No. 15 (Tobacco Control); ESMA standards
Pre-market Approval Required?	Yes [Pre-market Tobacco Product Application (PMTA) for vaping products; drug approvals for nicotine gum)	Yes (Novel Food approval for some products; TPD notification for tobacco products)	Yes (Therapeutic Goods Administration approval)	Conventional tobacco products – not subject to registration; Nicotine products – approval required from Drug Authorities; Vapes/e-cigarettes – not applicable	Yes (Registration and conformity assessment required)
Labeling Requirements	FDA labeling rules for tobacco and nicotine products, including warnings	EU TPD labeling requirements, health warnings	TGA labeling for therapeutic/tobacco products	Labeling requirements as per MoHFW, including warnings and prescribed content	Mandatory health warnings and labeling per ESMA/MOHAP
Timeline for Registration	12-24 months (PMTA review can be lengthy)	6-18 months, depending on product and approval	6-12 months depending on product class	Traditional tobacco – no registration pathway; Other nicotine categories – as applicable	6-12 months registration and approval

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