The question usually reaches us late. An overseas manufacturer appointed its Indian distributor as authorised agent to get the first import licence moving. Two years on, the relationship has soured and the manufacturer wants to move to a new partner — and discovers that the licence does not travel with the product. It sits with the agent.
The Indian authorised agent is the single most consequential appointment a foreign manufacturer makes for India. This guide sets out what the Medical Devices Rules, 2017 actually require of the role, who can hold it, what the agent files and signs, what it must do after the licence is granted, and where appointments go wrong.
What the Rules mean by “authorised agent”
Rule 3(f) of the Medical Devices Rules, 2017 defines an authorised agent as a person, including a firm or organisation, who has been appointed by an overseas manufacturer through a power of attorney to undertake import of medical devices into India. CDSCO’s own FAQ on the Rules repeats the definition in the same terms.
Three things follow from that definition. The agent is appointed by the manufacturer, not by CDSCO. The appointment is made by power of attorney, not by a distribution agreement. And the purpose of the appointment is import — the agent is the party that applies for, holds and answers for the import licence.
For most devices, an import licence is mandatory. CDSCO’s FAQ states that importers must obtain an import licence from the Central Licensing Authority under the Rules, with the exception of Class A devices that are non-sterile and non-measuring, which need a registration number rather than a licence. Either way, a foreign manufacturer without an Indian entity of its own cannot sell into India without an agent.
Who can act as your authorised agent
Rule 34(1) limits who may apply for an import licence: an authorised agent holding a licence to manufacture for sale or distribution, or a wholesale licence for sale or distribution. CDSCO’s checklist for a fresh Form MD-14 application and its FAQ also accept a registration certificate in Form MD-42, the certificate now issued to persons who sell, stock or distribute medical devices.
In practice, that means the agent must be an Indian entity that already holds one of three things before the import application is filed:
- a medical device manufacturing licence;
- a wholesale licence for sale or distribution; or
- a Form MD-42 registration certificate.
A foreign manufacturer’s Indian subsidiary can be the agent if it holds one of these. So can an independent regulatory firm, a distributor or an importer. The choice between them is commercial and strategic, and we return to it below.
The power of attorney and the agent’s undertaking
The power of attorney is the legal foundation of the whole arrangement. CDSCO’s FAQ requires it to be submitted together with an undertaking from the authorised agent as specified in Part I of the Fourth Schedule to the Rules. It must be authenticated in India, either by a Magistrate of First Class or by the Indian Embassy in the country of origin, or by an equivalent authority through apostille.
The power of attorney is also the document that determines scope. It names the manufacturer, the sites and the devices the agent is authorised to import. If a device or a manufacturing site is not covered, the application for it cannot rest on that document.
What the agent files: from Form MD-14 to Form MD-15
The agent submits the import licence application in Form MD-14 through the Ministry of Health and Family Welfare’s online portal, with the fee set in the Second Schedule and the documents set out in the Fourth Schedule (Rule 34). CDSCO’s checklist for a fresh MD-14 application lists the dossier the agent must assemble with the manufacturer:
- covering letter, Form MD-14 and fee challan;
- the authenticated power of attorney and the agent’s undertaking;
- the agent’s manufacturing licence, wholesale licence or MD-42 certificate, and its constitution details;
- Free Sale Certificate or marketing authorisation from the country of origin, if any, and from the USA, UK, EU, Canada, Japan or Australia where held, notarised;
- overseas manufacturing site or plant registration, and the latest inspection or audit report by a competent authority from the last three years, if any;
- quality management system certificate for the actual manufacturing site, applicable CE certificates and the manufacturer’s declaration of conformity;
- Plant Master File (Appendix I of the Fourth Schedule) and Device Master File (Appendix II), including batch release records or certificates of analysis for at least three consecutive batches.
Under Rule 36(1), the Central Licensing Authority grants the licence in Form MD-15 within nine months of the date of application, where it is satisfied with the documents. CDSCO’s FAQ adds that the Authority may inspect the overseas manufacturing site before or after grant. If the application is rejected, Rule 36(2) allows an appeal to the Central Government within 45 days.
Once granted, the licence remains valid in perpetuity unless cancelled or surrendered, provided the authorised agent deposits the licence retention fee with the Central Licensing Authority every five years (Rule 37). Note who pays it: the Rule places the obligation on the agent.
What the agent must do after the licence is granted
This is the part most appointments underestimate. Rule 38 sets the conditions an import licence holder must meet, and several of them fall expressly on the authorised agent:
- Produce the licence when a Medical Device Officer or other authorised officer asks for it.
- Report regulatory action abroad. Where a device is withdrawn, restricted or otherwise acted on by a regulator elsewhere, the licensee must inform the licensing authority forthwith, and in any event within fifteen days.
- Stop supply. In those cases the authorised agent must immediately stop despatch and marketing of the device.
- Follow directions from the Central Licensing Authority on marketing, sale, distribution or withdrawal from the Indian market.
- Obtain prior approval for major changes listed in the Sixth Schedule. The Authority responds within sixty days; if it does not, the change is deemed approved.
- Report minor changes within thirty days of their occurrence.
- Report changes in constitution of the overseas manufacturer or the agent in writing within thirty days.
- Ship correctly. Each consignment must travel with an invoice or statement showing the name and quantity of the device, and devices must be supplied with their package insert or user manual where applicable.
Under Rule 38(2), where a device is found not to conform, the Authority may stop sale of the batch or direct its recall, including from hospitals, and may extend that to further batches or all batches.
Two more practical duties sit outside Rule 38. Rule 44(n) requires imported devices to carry the import licence number, the importer’s name and address, the manufacturing premises address and the date of manufacture — by stickering, where these are not already printed on the label. And CDSCO’s FAQ confirms that medical devices may be imported only through ports notified under the Drugs Rules, 1945.
One agent or several, and what happens when you change
CDSCO’s FAQ answers two questions that shape every appointment.
Can more than one agent import the same product? Yes. More than one Indian authorised agent may import the same device for the same legal and actual manufacturer. A subsequent agent files its own Form MD-14 with a power of attorney, Free Sale Certificate, its own wholesale licence, MD-42 or manufacturing licence, labels and instructions for use, a copy of the earlier agent’s import licence, and the manufacturer’s undertaking that the Device Master File and Plant Master File are unchanged.
What happens if you change agent? The FAQ is direct: a change in Indian agent requires a fresh import licence. A fresh application is also needed where the constitution of the licensee changes, or where the overseas manufacturer’s location or manufacturing site changes. Rule 39 deals with changes in constitution and provides a 180-day period for the fresh application under Rule 34(1).
Read together, these two answers explain the scenario at the top of this article. The licence is held by the agent. Moving to a new agent means a new application and, until it is granted, no licence in the new agent’s name.
Where this goes wrong
Appointing a distributor as sole agent without an exit plan. A distributor that holds your only import licence holds your Indian market access. If you later want to change partner, the new agent starts from a fresh MD-14. Manufacturers who want commercial freedom either appoint an independent agent that does not compete for distribution, or plan a second agent early using the multiple-agent route above.
The agent is not yet eligible on the day of filing. Rule 34(1) requires the agent to hold a manufacturing or wholesale licence, and the checklist accepts MD-42. If the agent’s MD-42 or wholesale licence is still being processed by the state authority, the import application cannot be filed. Check this first, not last.
A power of attorney that is too narrow or not properly authenticated. A power of attorney that omits a manufacturing site, a device or the Part I undertaking — or that is notarised abroad but not authenticated by a Magistrate of First Class, the Indian Embassy or apostille — sends the file back.
A Free Sale Certificate that names only one manufacturer. CDSCO’s FAQ states that the Free Sale Certificate must carry the name and address of both the legal manufacturer and the actual manufacturer, and that a Certificate of Exportability is not accepted in its place. Where an OEM makes the device for a brand owner, check the certificate before it is notarised.
Missing the change-reporting clock. Rule 38(1)(viii) gives thirty days to report a change in constitution of the manufacturer or agent in writing. CDSCO’s FAQ refers to forty-five days for changes in name, address or constitution. Until the two are reconciled, plan to the shorter period in the Rule. Mergers, renamings and address changes at the overseas manufacturer are the usual triggers, and the agent often hears of them last.
Treating labelling as the manufacturer’s problem. Rule 44(n) particulars — import licence number, importer’s name and address — are Indian details the overseas factory will not print by default. If nobody arranges compliant stickering before the goods are released, the consignment is non-compliant on arrival.
Choosing your authorised agent
The Rules do not tell you whom to appoint, but they make the agent the face of your device to CDSCO for as long as the licence lives. Ask four questions of any candidate:
- Does it already hold a wholesale licence, manufacturing licence or MD-42 certificate, and for which premises?
- Does it have people who can prepare and defend a Device Master File and Plant Master File, and respond to CDSCO queries in your name?
- Will it stop supply and report overseas regulatory action within the Rule 38 timelines, even when that hurts its own sales?
- If you part ways, will it co-operate with your transition to a new agent?
Frequently asked questions
Does a foreign manufacturer need an Indian authorised agent to sell in India?
If it has no Indian entity of its own that holds a manufacturing licence, wholesale licence or MD-42 certificate, yes. Rule 34(1) allows only such an authorised agent to apply for an import licence, and CDSCO’s FAQ confirms an import licence is required for all devices other than non-sterile, non-measuring Class A devices, which need a registration number.
Can our Indian subsidiary be the authorised agent?
Yes, provided it holds one of the qualifying licences or the MD-42 certificate and is appointed by power of attorney with the Part I undertaking. Many manufacturers move to their own subsidiary once volumes justify it — remembering that a change of agent requires a fresh import licence.
How long does CDSCO take to grant the import licence?
Rule 36(1) sets nine months from the date of application for grant in Form MD-15, where the documents are satisfactory. Query responses and any overseas site inspection affect the actual time.
Do we have to renew the import licence?
No. Under Rule 37 the MD-15 licence remains valid in perpetuity unless cancelled or surrendered, but the authorised agent must deposit the licence retention fee every five years. Missing it puts the licence at risk.
Can we appoint more than one authorised agent?
Yes. CDSCO’s FAQ confirms that more than one Indian authorised agent may import the same device for the same legal and actual manufacturer, each under its own import licence.
Is the authorised agent responsible if a device is recalled abroad?
The agent is responsible for acting on it in India. Rule 38 requires the licensing authority to be informed within fifteen days of regulatory action abroad and requires the authorised agent to stop despatch and marketing immediately.
Medfins acts as Indian Authorised Agent for overseas manufacturers and prepares and manages the Form MD-14 import licence application through to MD-15. If you are appointing an agent for the first time, or reviewing an appointment you already have, contact our team with your device list and manufacturing sites, or see our Indian Authorised Agent service.
