1. Regulatory Documentation Gaps: DMF and PMF:

Indian submissions require highly detailed and structured documentation. Manufacturers often need to reformat or expand their existing documents to meet the CDSCO medical device registration India expectations. For example,

 The Device Master File (DMF) must include the below details:

• Manufacturing flowchart
  
  
• Clinical trial or published data
  
  
• Biocompatibility reports
  
  
• Physiochemical tests
  
  
• Risk Management Report
  
  
• Essential Principles Checklist
  
  
• Quality control for raw and finished products

The Plant Master File (PMF) must include the below details:

• Manufacturing site layout
  
  
• Process flow and QA/QC systems
  
  
• Organization structure
  
  
• Plant registration certificate from the National Regulatory Authority (NRA).

2. Process Validation and Biocompatibility Data:

Manufacturers often submit only high-level protocols for other international market approvals, however, medical device approval in India requires additional details such as simulated use, mechanical stress, and animal feasibility testing in the process validation report. Additionally, the Summary results must include the following – Bioburden testing, Pyrogen and sterility residue data and Packaging validation ISO 11607. For Biocompatibility reports, full reports and not summaries are required for cytotoxicity, sensitization, systemic toxicity, subchronic toxicity, genotoxicity, implantation, hemocompatibility, etc.

3. Shelf Life Evidence:

Both accelerated and real-time aging studies must be submitted. Submitting only one is not sufficient for approval and the CDSCO will raise a query for the same.

4. Product Classification & Grouping Issues:

CDSCO expects products grouped under one application to:

• Have the same intended use
  
  
• Have the same material of construction
  
  
• Have the same design

Additionally, the CDSCO released an FAQ stating that the products which come under the same brand name would be considered to be one family, else, separate CDSCO fees would have to be paid. For example, previously, an orthopaedic manufacturer could register their implants – plates, burrs and screws under one family in India. But now, the applicant needs to apply for them separately, increasing the cost of CDSCO fees.

5. Power of Attorney and Legalisation Issues:

The manufacturer’s name should match across the Form 40, FSC, Schedule D(I), and POA. In terms of the article numbers and pack sizes, they must match the Free Sale Certificate and CDSCO forms. Additionally, The POA must be apostilled, not just notarized.

6. Labeling & Predicate Device Evidence:

The CDSCO mandates a predicate device comparison chart, which directly impacts the timelines for approval. Basically, if the product does not have an identical predicate, the manufacturer must be prepared that they will have to go through the MD-26 pathway wherein the CDSCO will decide if trials will be required and if yes, what the pathway would be. If a predicate and GHTF Approval (Approval from US, Canada Japan, Australia, EU, UK) is available, then the process is relatively straightforward and takes 6-9 months to get approved.

As per the Legal Meteorology (Packaged Commodity) Rules, 2011 an India specific artwork must include the below:

• Importer Details
  
  
• Import License Number
  
  
• Month/ Year of Import
  
  
• Maximum Retail Price (MRP)

This label can be customized based on the Manufacturer and Morulaa can support in creating a template for the same.

7. Certificates and Validity Criteria:

 When a manufacturer prepares the documents for medical device registration in India, they need to ensure that all certificates (e.g., FSC, DoC) must be valid for at least six months at the time of submission and must also keep in mind that CE Design Certificates are not accepted for Class I and II devices. Additionally, each product must have its own DoC with risk classification, printed on the manufacturer’s letterhead and signed by authorized personnel.

8. Price Control by NPPA:

As per the National Pharmaceutical Pricing Authority (NPPA), all medical devices companies in India must follow the below:

• Devices on the NPPA’s Schedule list are subject to ceiling prices.
  
  
• Even non-scheduled devices cannot exceed a 10% price increase annually.
  
  
• NPPA has authority to fix prices in public interest, affecting manufacturers’ selling price in the market.

For example, if you are selling Stents into India, there is a cap at which they can be sold. For more information, click here.

9. Clinical Investigation and Post-Market Data:

For Class C and D devices, CDSCO may demand Local clinical investigations unless the device has –

• Two years of post-market use in India or
• An equivalent model already approved in India.

The Evidence must include Indian sales data or global post-market surveillance data.

10. Import Duties and Valuation:

Import duties and valuation play an important role when importing medical devices into India. Devices are subject to varying rates of import duty, typically ranging from 0% to 28%, depending on how the product is classified under the Harmonized System of Nomenclature (HSN) code. The HSN code determines the specific category a product falls under, which directly impacts the applicable rate of customs duty. The declared value of the imported goods must be genuine and fully supported by appropriate documentation, such as purchase invoices, shipping documents, and product catalogs. If customs authorities detect any discrepancies or suspect that the product has been undervalued or misclassified, they have the authority to delay clearance, reassess the shipment, impose fines or penalties, or even mandate that the goods be returned to the country of origin. Therefore, at the time of customs clearance, all importers must be fully prepared to justify the pricing and classification of their products with proper documentation and transparency to avoid delays and complications.

11. Foreign Exchange Compliance (FEMA):

Invoicing and payments between overseas companies and Indian partners must be in accordance with FEMA regulations. Repatriation of funds requires clear documentation and a transparent transaction flow. Manufacturers should also factor in GST, TDS, and, where relevant, transfer pricing requirements

12. Promotional and Advertising Restrictions:

The Uniform Code for Marketing Practices in Medical Devices (UCMPMD) 2024 sets basic rules for how medical device manufacturers in India should promote their products. It bans giving gifts or other benefits to healthcare professionals and requires honest advertising and labeling. Companies must submit a yearly declaration confirming they follow the rules.