CDSCO import licence for medical devices: MDR 2017, Form MD-14 and MD-15, Class A to D, USD fees and timelines

India regulates medical devices as a category of drugs under the Drugs and Cosmetics Act, 1940^[2]. The detailed rules are the Medical Devices Rules, 2017 (MDR), notified as G.S.R. 78(E) on 31 January 2017 and in force from 1 January 2018^[1]. The regulator is the Central Drugs Standard Control Organisation (CDSCO), and import licences are issued by the Central Licensing Authority^[3].

The core rule for importers is that you need a licence before you import a medical device for sale. CDSCO's own FAQ says that for the import of medical devices, the applicant has to obtain an import licence under MDR 2017 from the Central Licensing Authority; only Class A non-sterile, non-measuring devices take a lighter registration route instead^[4]. The application is Form MD-14 and the licence is Form MD-15, issued by the Central Licensing Authority for devices in all four classes, A to D^[3].

Four points decide how hard this is for you:

• Is your product a medical device at all? Since 1 April 2020, the definition covers all devices, including software and accessories, intended for diagnosis, prevention, monitoring, treatment or alleviation of disease, and several other medical purposes^[2]. Intended use, not technology, decides.
• Which risk class is it? Class A is low risk and Class D high risk^[4]. Fees and evidence rise with the class.
• Who is your Indian applicant? Only an authorised agent with a manufacturing licence, a wholesale licence or a Form MD-42 registration can apply^[1].
• Where is the device already approved? A free sale certificate from Australia, Canada, Japan, the EU, the UK or the USA lets CDSCO grant the licence without clinical investigation^[1].

The CDSCO licence is separate from your IEC and from product-safety schemes such as BIS CRS. An electronic medical device can need several of these at once.

If your product also has a radio, a battery or a mains plug, CDSCO is only one of several approvals. Run it through our approval checker or the HS code approval finder first, and see the first-time importer guide for the basics such as the Importer Exporter Code.

In 2026 the Ministry amended the Medical Devices Rules twice on 14 August, and several drafts are still pending. None of the final changes we found rewrites the import licence route described on this page, but read them if your device is new to the market, sterilised, or Class A non-sterile and non-measuring.

• 14 August 2026, G.S.R. 744(E). CDSCO lists it as an amendment for the inclusion of EU countries in rule 63 and quality management system requirements for Class A non-sterile, non-measuring devices^[5]. Class A non-sterile, non-measuring devices were until now exempt from several chapters of the rules and only had to register^[4], so importers of such devices should read the new QMS requirement closely.
• 14 August 2026, G.S.R. 743(E). An amendment introducing a Ninth Schedule and labelling requirements for sterilisation activities^[5].
• Drafts. A draft of 23 June 2026 proposes further MDR amendments^[5], and drafts of 10 April 2026 deal with testing fees and EU-related provisions^[5].
• Testing officers. In February and March 2026 the Ministry notified Medical Device Testing Officers for labs and the qualifications of device inspectors and government analysts^[5].

We have read these notifications' titles on CDSCO's list, not their full text, so we do not describe their detail. See our 2026 rules tracker for other import rules that changed this year.

Until 2020 CDSCO regulated only a notified list of devices. That changed with S.O. 648(E) of 11 February 2020, which, from 1 April 2020, declared as drugs all devices intended for human or animal use for any of six purposes: diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder; diagnosis, monitoring, treatment of or assistance for any injury or disability; investigation, replacement or modification of anatomy or a physiological process; supporting or sustaining life; disinfection of medical devices; and control of conception^[2].

Newly covered devices were given a transition. G.S.R. 102(E) let them be registered rather than licensed, but that exemption ended 30 months from the notification for Class A and B devices and 42 months for Class C and D devices^[6]. Both periods have long passed. CDSCO now says all medical devices are in the licensing regime except Class A non-sterile, non-measuring devices, and a registration number obtained during the transition is not an approval to import^[4].

Software counts. Standalone software that meets the S.O. 648(E) definition is regulated under MDR 2017^[4], and CDSCO gives the same answer for software marketed for fitness or wellness: if it meets the definition, it is regulated^[4].

Wellness is the dividing line. CDSCO's example is massagers: one intended only for soothing or general wellness is outside the rules, but one intended for a therapeutic purpose or to alleviate a disease or disorder is regulated^[4].

MDR 2017 uses four risk classes: Class A low risk, Class B low-moderate, Class C moderate-high and Class D high risk^[4]. You do not choose your class freely. The Central Licensing Authority classifies devices by intended use and the parameters in the First Schedule and publishes class-wise lists on the CDSCO website; where your device's class in India differs from its class in IMDRF or GHTF countries, CDSCO may consider the higher class^[4].

The class drives three things: who your licensing authority is for local manufacture, the fee, and the clinical evidence CDSCO expects. For imports, the Central Licensing Authority licenses all four classes^[3].

Class A split. Class A devices that are non-sterile and do not have a measuring function are exempt from the licensing chapters of MDR, under G.S.R. 777(E) of 14 October 2022, but they must still be registered on the online portal and labelled correctly^[4]. That registration gives a system-generated number and costs nothing^[4]. A device has a measuring function if it is intended to measure a physiological or anatomical parameter, or energy or substances delivered to or removed from the body, and show the result in legal or acceptable units^[4]. A sterile Class A device, or a Class A device that measures, still needs the full import licence.

The overseas manufacturer cannot apply directly. Rule 34(1) says the application is made by an authorised agent holding a licence to manufacture for sale or distribution, a wholesale licence for sale or distribution, or a registration certificate in Form MD-42^[1]. An authorised agent is a person, firm or organisation appointed by the overseas manufacturer through a power of attorney to import its device into India^[4].

So the usual set-up is:

1. The foreign manufacturer signs a power of attorney appointing an Indian company as its authorised agent.
2. That Indian company holds a wholesale drug licence or a Form MD-42 registration to sell or distribute medical devices. The MD-42 certificate is valid in perpetuity subject to a retention fee before every five years^[1].
3. The Indian company also has its own IEC, because it is the importer of record.

More than one importer is allowed. Several authorised agents can import the same device from the same manufacturer. The later agent files Form MD-14, its own power of attorney, the free sale certificate, fees, its licence, the label and IFU, a copy of the first agent's import licence, and an undertaking from the manufacturer that nothing has changed in the device and plant master files^[4].

Changes need a fresh licence. A new import licence is needed if the licensee's constitution changes, the manufacturer who signed the power of attorney changes, or the actual manufacturing site moves^[4]. Plan distributor changes with this in mind.

Only an authorised person of the company, not an outside consultant, can ask CDSCO about the status of an application^[4].

All MDR applications are online, through www.cdscomdonline.gov.in or the National Single Window System at www.nsws.gov.in^[4]. The sequence below follows rule 34 to rule 36 and the CDSCO checklist.

Testing. Rule 34(3) allows CDSCO to have the device evaluated or tested if it has reason to believe quality is compromised, and the authorised agent pays the testing laboratory^[1].

Inspection. CDSCO may inspect the overseas manufacturing site itself or through a delegate, and the applicant pays USD 6,000 for the visit^[1].

Clinical evidence. This is where the country of approval matters. If the device has a free sale certificate from Australia, Canada, Japan, the EU, the UK or the USA, the licence is granted without clinical investigation^[1]. If it is approved only elsewhere, Class C and D devices may need clinical investigation in India, while Class A and B can rely on published safety and performance data or clinical investigation in the country of origin plus a free sale certificate^[1].

Adding products later. A licence for an additional device from the same site, or an additional site for the same device, is a subsequent application with its own fee and documents^[1].

Quality system. Importers do not run the manufacturing QMS themselves, but they must submit a quality certificate showing the manufacturer conforms to a QMS as the Fourth Schedule requires^[4].

CDSCO publishes a checklist for fresh MD-14 applications. In summary, it asks for a covering letter, the MD-14 form, the fee challan, a power of attorney with undertaking authenticated by a first-class magistrate, an Indian embassy or apostille, the agent's wholesale or manufacturing licence or MD-42, free sale certificates, site registration, QMS and CE certificates, and the plant and device master files^[7]. The Device Master File alone has around twenty parts, from device description and grouping justification to software validation, stability data, clinical evidence, post-market data and batch release certificates for three consecutive batches^[7].

Import fees under the Second Schedule of MDR 2017 are charged in US dollars, per manufacturing site and per distinct device. For devices other than in-vitro diagnostics, the figures are:

• Class A (sterile or measuring): USD 1,000 per site plus USD 50 per device^[1].
• Class B: USD 2,000 per site plus USD 1,000 per device^[1].
• Class C or D: USD 3,000 per site plus USD 1,500 per device^[1].

In-vitro diagnostics are cheaper per product: USD 1,000 per site plus USD 10 per IVD for Class A and B, and USD 3,000 per site plus USD 500 per IVD for Class C and D^[1].

Three rules push the bill up. A separate fee applies to each brand^[4]. If one site makes devices in several classes, the fee is set by the risk class of the devices^[4]. And MDR has no provision to refund fees, even if you withdraw^[4].

A worked example using only the Second Schedule figures. Suppose an Indian distributor wants to import three Class B devices (say, three distinct models) from one overseas factory under one brand.

• Site fee for Class B: USD 2,000^[1]
• Device fee: 3 x USD 1,000 = USD 3,000^[1]
• Government fee: USD 5,000, before any inspection.

If CDSCO decides to inspect the overseas site, add USD 6,000^[1], taking the total to USD 11,000. A second brand of the same devices would need its own device fees^[4].

Five years after the licence is issued, the retention fee falls due at the same rates: USD 2,000 for the Class B site and USD 1,000 for each device^[1].

What the example leaves out: notarisation and apostille of the power of attorney and certificates, preparation of the master files, any test fees CDSCO orders, and consultant charges. None of these are in the Second Schedule.

Rule 36(1) gives CDSCO nine months from the date of application to grant the licence in Form MD-15 or reject it with written reasons^[1]. CDSCO's FAQ repeats that the timeline is nine months, provided the documents are satisfactory^[1]. There is no deemed approval if CDSCO takes longer.

If CDSCO rejects the application, you can appeal to the Central Government within 45 days, and the Government may decide the appeal within 90 days^[1].

The route for Class A non-sterile, non-measuring devices is far quicker: the registration number is system-generated once the information is entered on the portal^[4].

For small personal imports, rule 43 sets a seven-day decision period for Form MD-20 applications, decided by permission in Form MD-21^[1].

There is no renewal in the old sense. Rule 37 says an import licence remains valid in perpetuity, unless cancelled or surrendered, as long as the authorised agent pays the licence retention fee for each overseas site and each licensed device after every five years from the date of issue^[1].

Miss the date and there is a short grace period. The retention fee can be paid up to 90 days late with a late fee of 2% per month; after that the licence is deemed cancelled^[1]. The retention fee follows the same table as the grant fee^[1].

CDSCO has clarified a practical point: if you submit the retention application with the fee in time, the licence is treated as valid and you can keep marketing the product even if the acknowledgement has not yet arrived^[4].

Remember that some changes need a completely new licence rather than a retention, such as a new manufacturing site or a change in the manufacturer who executed the power of attorney^[4].

Worked example. A licence issued on 1 December 2026 needs its retention fee paid by 1 December 2031, five years from issue^[1]. For one Class B site with three devices, the retention fee mirrors the grant fee: USD 2,000 for the site plus 3 × USD 1,000, so USD 5,000^[1]. Paid 60 days late, that attracts a late fee of 2% a month, about four per cent; after 90 days the licence is deemed cancelled^[1]. Diary the date with our licence renewal date tool or compliance calendar.

Rule 44 sets the label content for all devices: the device name, details to identify the device and its use, manufacturer name and manufacturing site address, net quantity, month and year of manufacture and expiry (or shelf life), batch or lot number, special storage conditions, sterile state and method if sterile, and single-use marking where relevant^[1].

For imported devices, rule 44(n) adds the import licence number, the importer's name and address, the address of the actual manufacturing premises and the date of manufacture, and allows these to be added by sticker in India if they are not already printed^[1]. Class A non-sterile, non-measuring devices, though exempt from licensing, must still meet these labelling rules^[4].

Residual shelf life at import. Rule 47 blocks imports with too little shelf life left: less than 40% where total shelf life is under 90 days, less than 50% where it is 90 days to one year, and less than 60% where it is more than a year^[1]. Ship fresh stock.

If the device is a retail pre-packaged product, the general package declarations under LMPC can also apply; our product label checklist covers how the different label rules fit together.

The CDSCO label sits alongside the Legal Metrology package declarations for retail packs; see our Legal Metrology label rules, the LMPC importer registration guide and the product label checklist, and test your artwork with the label checker.

You need an Importer Exporter Code, the CDSCO import licence or Class A registration number, and labels that already carry the India-specific details. Missing any one is a common reason a consignment sits at the port.

The IEC. No one may import without an IEC unless exempted^[8]. It is applied for online on the DGFT portal for Rs 500^[9]; see our IEC guide and the DGFT portal guide.

The licence. A licence from the Central Licensing Authority is needed to import devices for marketing; Class A non-sterile, non-measuring devices need a registration number instead^[4]. CDSCO says the old registration number is not a regulatory approval to import^[4].

The label. The import licence number, the importer's name and address, the manufacturing site address and the date of manufacture must be on the label, by sticker if not printed^[1].

Shelf life. Devices cannot be imported with less than 40%, 50% or 60% of their shelf life left, depending on total shelf life^[1]. A device with a two-year shelf life must arrive with at least 60% of it left, so ship stock within about nine months of manufacture.

The customs clearance documents checklist, our ICEGATE guide and the article on why shipments get held at Indian ports cover the rest, including the bill of entry and the role of your customs broker.

Three situations, worked through with the rules above.

1. A distributor importing blood pressure monitors. A Chennai distributor wants to import two models of digital BP monitor from a factory in Taiwan. A BP monitor measures a physiological parameter, so it is a measuring device^[4] and cannot use the Class A exemption even if it were Class A^[4]. The distributor first gets a wholesale licence or an MD-42 registration, because only such an authorised agent can apply^[1]. It obtains a power of attorney from the manufacturer, files MD-14 on the portal with the device and plant master files, and pays the site fee plus the per-device fee for each of the two models at the rate for the class CDSCO lists. If the monitors hold an EU or US approval, the free sale certificate lets CDSCO grant the licence without clinical investigation^[1]. The distributor plans stock for a decision within nine months^[1].

2. A smartwatch brand adding a health feature. An Indian brand imports smartwatches under BIS CRS, where smart watches are a listed category^[10]. Its next model adds a feature marketed as detecting an irregular heart rhythm. That claim is about monitoring or diagnosing a disorder, which brings the feature within the device definition^[2], and software doing it is regulated too^[4]. The brand now needs to classify the feature, find an Indian authorised agent and plan for an MD-14 application, or market the watch without the medical claim. See our smartwatches page for the non-medical approvals.

3. An importer of a low-risk, non-sterile product. An e-commerce seller imports a Class A product that is non-sterile and has no measuring function. It does not need an MD-15 licence. It registers the product on the medical devices portal, gets a free system-generated number^[4], and makes sure the label meets rule 44, including the importer details for imported devices^[1]. If CDSCO's list puts the product in a higher class, the full licence applies instead^[4].

Most delays come from documents that do not meet the checklist, or from evidence that does not fit the device's class.

The licence carries continuing duties. Under rule 38, the licensee must inform CDSCO within 15 days of any regulatory action abroad, such as a market withdrawal, cancellation or a not-of-standard-quality declaration, and stop dispatch and marketing of that device^[1].

If the importer fails to comply with licence conditions or the Act and rules, rule 43A allows the Central Licensing Authority, after a show-cause notice, to suspend or cancel the licence, direct the licensee to stop import, sale or distribution, and order destruction of the stock; an appeal lies to the Central Government within 30 days^[1].

Non-payment of the retention fee ends the licence automatically after the 90-day grace period^[1]. Import without any licence leaves the goods unable to clear Customs, and the earlier transition-era registration number is not a valid approval^[4].

Yes, in small quantities. Rule 43 lets a person bring a device in personal baggage for their own use if it is prescribed by a registered medical practitioner, the quantity does not exceed the prescription and it is declared to Customs if asked. Outside baggage, the person applies in Form MD-20 with the prescription, and CDSCO grants permission in Form MD-21 or rejects within seven days^[1].

This route is not for business samples. Devices for test, evaluation, demonstration or training need an import licence for those purposes, at USD 100 per device^[1].

Start with CDSCO's own online portal and checklist; bring in a regulatory consultant if you have no in-house regulatory staff. Only an authorised person of your company, not a third-party consultant, can ask CDSCO about the status of an application^[4], so keep that contact in-house.

• Foreign makers should read our guide for foreign manufacturers and the sourcing guides for the USA, Germany, Japan and China. Free sale certificates from Australia, Canada, Japan, the EU, the UK or the USA avoid clinical investigation in India^[1].
• Documents for the import itself are listed in our import documents guide.
• A second opinion. Ask us for a free compliance check on your product list.

A connected or battery-powered device can also need a WPC approval for its radio, battery and e-waste EPR registration as a producer, and Legal Metrology registration for retail packs. CDSCO approval does not replace any of them.

• Radio. WPC's Equipment Type Approval is needed to import, sell and use wireless devices in de-licensed bands^[11]. A Bluetooth pulse oximeter or BP monitor falls into that net; see WPC ETA and how to get WPC approval.
• Batteries. Anyone who imports equipment containing batteries is a battery producer^[12], so a battery-powered device brings battery EPR with it.
• E-waste. Many electrical devices are listed for e-waste EPR; check the EEE code for your product.
• Packaging. Importers of pre-packed goods register under Legal Metrology rule 27^[13]; see LMPC.
• Safety marks. Consumer electronics such as smartwatches and Bluetooth earphones need BIS CRS as products; whether a medical-purpose version is covered depends on the order, so check before you ship.

Our cost of importing electronics page and the compliance cost estimator help you add these up, and the 2026 compliance fee table lists the official fees side by side.

Electronic medical devices often sit under several regimes. A connected health monitor, for example, could need CDSCO for its medical purpose, a WPC ETA for its radio, and EPR obligations as electrical equipment. The table sets out how they differ.