Challenges Faced by Overseas Medical Device Manufacturers While Entering the Indian Market: Insights from Morulaa HealthTech on Navigating India’s Multi Layered Regulatory Framework
Overseas Medical Device Makers: India Entry Challenges Guide
Regulatory approval by the Central Drugs Standard Control Organization (CDSCO) alone is just not sufficient for the international manufacturer of medical devices looking to venture into the Indian medical device market. The regulation of the Indian medical devices industry involves several regulatory organizations that have different compliance guidelines as follows:
NPPA (National Pharmaceutical Pricing Authority) for Price Fixation
CPCB (Central Pollution Control Board) for E-Waste and Plastic Waste
Environment Ministry for Packaging
FEMA (Foreign Exchange Management Act) for Structuring and Profit Repatriation
Customs for Value of Goods and Duties
Advertising Laws and Codes (UCPMP, DMR Act)
Morulaa HealthTech helps medical device manufacturers understand these different medical device regulations in India.
What are the common challenges a manufacturer faces when they are looking to enter India? Some of the common ones are as below
1. Documentation Issues in Terms of Regulations: DMF & PMF
The Indian regulatory submissions need extensive and properly formatted documents. The manufacturers have to make changes in their documents to meet the requirement of the registration of medical devices India imposed by CDSCO.
For example,
DMF must contain the following information:
Manufacturing process flowchart
Clinical trial or scientific literature
Biocompatibility data
Physico-chemical testing data
Risk assessment report
Checklist of Essential Principles
QC of raw materials and finished goods
PMF must include the following information:
Manufacturing plant floor plan
Process flow and QA/QC System
Organization chart
2. Process Validation and Biocompatibility Data:
The manufacturers usually send high-level protocols for other international markets’ approval but for the approval of medical devices in India, more information needs to be provided which includes simulation of use, mechanical stress test and animal feasibility study in process validation data. Moreover, the summary data needs to have the following bioburden testing, pyrogen and sterility residue data, packaging validation ISO 11607. For biocompatibility data, full reports and not summaries are needed for cytotoxicity, sensitization, systemic toxicity, subchronic toxicity, genotoxicity, implantation, hemocompatibility, etc.
3. Shelf Life Data:
The manufacturer should provide both accelerated and real time aging data for approval of medical devices in India. Providing only one of these is not enough.
4. Product Classification and Family Issues:
Products classified under the same application should:
Have the same purpose
Be made from the same material
Be designed similarly
Moreover, CDSCO also provided a guideline where it was mentioned that if the products belong to the same family name, then they will be considered one family; otherwise, they will be subjected to different CDSCO fees. Previously, an orthopaedic manufacturer used to register his implants such as plates, burrs and screws under one family in India. But now, he has to apply separately for each of these implants, thereby increasing CDSCO fees.
5. POA and Legalisation Issue
The manufacturer’s name should be consistent between the Form 40, FSC, Schedule D(I), and POA. As far as the article numbers and pack sizes are concerned, they should be consistent with the Free Sale Certificate and CDSCO forms. Furthermore, the POA must be apostilled.
6. Labeling & Predicate Device
It needs to be understood that a predicate device comparison chart is a requirement of the CDSCO, which affects the timescale of approval. What it means is that when the product does not have an identical predicate device, the manufacturer should know in advance that he is likely to face the MD-26 route, where the CDSCO will decide whether trials are necessary or not, and if yes, what the route will be. But if the predicate device and GHTF Approval (Approval from US, Canada Japan, Australia, EU, UK) are there, the process becomes quite easy and takes 6-9 months.
According to the legal rules of the Legal Meteorology (Packaged Commodity), 2011 the following information must be there in case of an artwork specific to India:
Importer Details
Import License Number
Month/Year of Import
Maximum Retail Price (MRP)
The above label can be customized depending upon the manufacturer and Morulaa can help in doing so.
7. Certificates & Validity Criteria
It is important to note when preparing documents for the registration of a medical device in India that all certificates (FSC, DoC) must be valid for six months from the date of submission. It is also important to note that CE Design Certificate is not accepted for Class I and II devices. In addition, each device must have its own DoC with risk classification on the manufacturer's letterhead.
8. NPPA Pricing Regulations:
As per the guidelines of the National Pharmaceutical Pricing Authority (NPPA), all the companies involved in the medical devices industry in India must adhere to the following:
If the product falls under the NPPA Schedule, then it is bound by the ceiling price.
Products which are not in the NPPA Schedule can see an increase of not more than 10% in price every year.
NPPA is authorized to set prices in the interest of the public, thereby affecting the price at which the manufacturer sells the product in the market. For example, in case you are selling Stents to India, there is a limit beyond which you cannot sell. Find out more here.
9. Clinical Investigation and Post-Market Data:
In cases of Class C and D medical devices, CDSCO may demand local clinical trials only if the product is not having
Two years' experience in the Indian market or
Equivalent of the device already cleared in the Indian market.
The data should be based on Sales data from India or international post marketing data.
10. Import Duties and Valuation:
It will be necessary to consider the import duties and valuation in the case of imports of medical devices in India. Import duties applicable to the imports of medical devices are not uniform but range from 0% to 28% depending on the HSN code of the imported item. What is worth noting is that the HSN code of the product imported helps to categorize the product under one particular classification and thus determine the customs duty payable for the importation of such a good. Moreover, the valuation of the product must be genuine and properly documented using purchase invoices, bills of lading and catalogs of the imported products. In the event of any doubt in respect of the valuation and classification of products, customs officials have the power to hold the goods till clearance and penalties are levied.
11. Foreign Exchange Compliance (FEMA):
The payment procedures and the invoices related between the foreign firm and its counterpart in India need to adhere to the FEMA rules. Money repatriation will require documentation and visibility in the entire process of transaction. The manufacturing firm will also need to keep in mind GST, TDS, and also transfer pricing if required.
12. Promotional and Advertising Restrictions:
Basic rules of conduct that the Indian manufacturers of medical devices need to adhere to while marketing their devices are described in the Guidelines of the UCMPMD for 2024. Any gifts or inducements cannot be given to the healthcare professionals. There should be no misleading statements made on marketing and labeling of products. Annual declaration from the companies with respect to compliance with guidelines is mandatory.
Why Work With Morulaa HealthTech
Morulaa HealthTech gives help to medical devices manufacturers from other countries who work in India. We offer help in meeting all the regulatory requirements for medical devices in India listed above:
DMF, PMF formatting and preparation, risk and test reports
POA, Schedule D(I), Form 40 legalization
Sterilization and biocompatibility testing and review help
Labeling help, model mapping and predicate
Price help and NPPA documents
Classification and import duty help
Help with FEMA invoicing and foreign exchange related matters
Clinical trial waiver application preparation
Documentation without risking IP and agency communication
Query resolution by CDSCO and post approval compliance
We are based in the USA, Europe, Asia, and Oceania regions and make sure that the documentation and strategy that we offer are fully compliant not only with the CDSCO medical device registration India regulations, but also with other regulations.
Conclusion
How to register your medical device in India? This is a tricky procedure that requires more than CDSCO licensing. The Indian regulatory framework is no longer limited to CDSCO regulations today, it covers such aspects as prices, waste disposal, packaging, currency, advertising and many more. Those who take into consideration only one particular issue often run into problems and may even be refused. With its ten years of experience, Morulaa HealthTech will help you solve all the issues related to medical device manufacturing in India.
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