Placing a Single-Use Medical Device in India: The 2026 CDSCO Route

Which Indian instruments govern a foreign single-use device in 2026?

The decision in this page is narrow: what must be true before a sterile single-use device made outside India can be imported for sale. The charter is the Medical Devices Rules, 2017, made under the Drugs and Cosmetics Act, 1940, and in force from 1 January 2018.³ Notification S.O. 648(E) of 11 February 2020 brought devices that had sat outside the old notified list into those rules.¹

G.S.R. 102(E), also dated 11 February 2020, issued registration numbers during the transition. FAQ answers 1 and 2 are direct. All medical devices are regulated under the 2017 rules. A G.S.R. 102(E) registration number is not a regulatory approval to manufacture or import. The licensing regime applies except for Class A devices that are non-sterile and non-measuring.¹ Treat a G.S.R. 102(E) number on an old certificate as a historical file reference, not as current permission to ship.

Two authorities divide the work.¹³

• Central Licensing Authority. The Drugs Controller General (India), at CDSCO in New Delhi. The CLA handles import of every class, manufacture of Class C and Class D, clinical investigation of a device that has no predicate, and risk classification.
• State Licensing Authority. The state drugs controller. The state handles manufacture of Class A and Class B and sale of every class, including a Form MD-42 registration certificate for a device distributor.

Device applications go through the Online System for Medical Devices at cdscomdonline.gov.in. FAQ 8 also names the National Single Window System. On 28 September 2026 the device portal itself labelled SUGAM as an older version. Some older CDSCO web pages still tell an applicant to file Form MD-14 on SUGAM. Use the screen that matches the current device portal, and do not treat a SUGAM screenshot alone as proof that a 2026 device file was filed.¹⁴

A draft Drugs, Medical Devices and Cosmetics Bill, 2026 has been reported as a proposal sent to other ministries for comment, intended to replace the 1940 Act.¹² Eleven associations wrote to the health minister on 8 August 2026 asking for the draft to be re-examined and for a separate devices law.¹³ It is not an Act. A file prepared now is built on the 2017 rules. Do not drop a dossier item because a draft bill might reorganize a board or a penalty.

Registration or import licence: which route does the device fall under?

FAQ 88 draws the line for import. An import licence from the CLA is required, except that a Class A non-sterile, non-measuring device completes a registration and receives a registration number.¹ FAQ 69 says those Class A devices are exempt from Chapters IV, V, VII, VIII, and XI. They are not exempt from labeling under Chapter VI or from applicable standards. FAQ 70 says the result is a system-generated registration number after the required information is furnished. It does not call the number instantaneous, and it does not call it a licence. FAQ 71 says there is no fee.¹

Everything else is Form MD-14, granted as Form MD-15 if the CLA is satisfied. That includes every Class B, C, and D device, and any Class A device that is supplied sterile or has a measuring function.¹³ The Fourth Schedule sets the import documents. FAQ 89 names Form MD-14 with Parts I, II, and III (Appendix I and II) of that schedule, plus the Second Schedule fee.¹

Sterility is a route switch, not a class switch. A Class A device that is marketed sterile loses the registration exemption and needs an import licence. It is still Class A unless the CLA has placed it higher, and the Class A import fee is the Class A fee. Do not budget a Class B fee merely because the pouch is sterile.¹²

Who can hold the licence when the manufacturer is abroad?

Rule 34(1) says the application is made by an authorised agent who already holds a licence to manufacture for sale or distribution, or a wholesale licence for sale or distribution, under these rules.³ FAQ 90 states the same test in operational language: a firm holding a valid licence to manufacture the devices, a wholesale licence, or a registration certificate in Form MD-42.¹ A foreign company does not file in its own name and does not become the Indian licence holder.

FAQ 144 is the point distributors miss. If the trader stocks and sells medical devices only, Form 20B, Form 21B, or Form 21C under the Drugs Rules is not mandatory. That trader obtains Form MD-42.¹ FAQ 143 confirms the other direction: a wholesale licence already issued under the Drugs and Cosmetics Rules, 1945 can be used to stock and distribute devices. An Indian manufacturer can also be the applicant. The holder is one of those three, not 'any Indian company with a GST number'.

Form MD-42 is applied for on Form MD-41 to the State Licensing Authority. FAQ 147 says the state may issue Form MD-42 within ten days from the date of application if the information is satisfactory. The FAQ says ten days, not ten working days. FAQ 148 says the certificate is perpetual, subject to a retention fee every five years.¹ The FAQ does not, in those answers, prescribe a pharmacist, a science graduate, or one year of device experience. Ask the state checklist for premises and personnel. Do not copy a drug-wholesale staffing rule into an MD-42 file without reading that checklist.

The overseas manufacturer appoints that Indian entity by a power of attorney. FAQ 102 requires the power of attorney in Part I of the Fourth Schedule, authenticated in India by a magistrate of the first class, by the Indian embassy in the country of origin, or by an equivalent authority through apostille.¹ A company chop and a notarization that is none of those three is not the authentication the FAQ describes.

Several changes force a new import licence. They do not all have the same interim status.

• Change of Indian agent. FAQ 104: a fresh import licence is required.¹
• Constitution, the manufacturer who signed the power of attorney, or the actual site. FAQ 92 requires a fresh import-licence application for a change in the constitution of the licensee, a change in the overseas manufacturer who executed the power of attorney, and a change in the location of the actual manufacturing site.¹
• Interim validity after a constitution change. Rule 39 requires the fresh Rule 34 application within 180 days of the change in constitution. The existing licence is deemed valid until the fresh licence is issued or the application is rejected. The explanation says the licensee includes the overseas manufacturer who executed the power of attorney. Do not apply that 180-day deeming sentence to a site move unless the text you are filing against says so. FAQ 92 still requires a fresh licence for a site move.³

Exclusivity is not required. FAQ 94 says more than one authorised Indian agent may import the same product from the same legal and actual manufacturer. FAQ 95 says a subsequent applicant submits Form MD-14, the new power of attorney, the free-sale certificate, the fee, the wholesale licence or Form MD-42 or manufacturing licence, the label, the instructions for use, a copy of the earlier import licence, and an undertaking that the device master file and plant master file are unchanged.¹ From 11 September 2025, CDSCO made a separate subsequent-importer provision functional on cdscomdonline.gov.in for devices and IVDs the CLA has already approved. The circular, listed on 15 September 2025, tells the applicant to use the checklist for that provision.⁵⁶ Use the portal checklist for the upload. Use FAQ 95 for what the underlying file still has to show. The lane does not let a second importer skip the fee or appoint itself without the manufacturer's undertaking.

What do the official fees and the statutory clock actually say?

Import fees in the Second Schedule are stated in US dollars, per overseas site and per distinct device. FAQ 13 points to that schedule. FAQ 14 says the rules contain no provision for a refund if the applicant withdraws. That answer is not Rule 34(3). Rule 34(3) is a different sentence: if the CLA believes quality is compromised and orders a test, the agent pays the testing laboratory the fee the CLA specifies.¹²³

FAQ 15 requires a separate fee for each brand applied for. A second brand name on the same construction is another device fee, not a free alias.¹

In vitro diagnostics use different device fees on the same help file: $1,000 per site and $10 per device for Class A or B, and $3,000 per site and $500 per device for Class C or D. This page does not walk an IVD dossier. Do not paste the non-IVD device column onto a reagent or an instrument.²

Rule 35 allows the CLA to inspect the overseas site before or after grant, itself or through a delegate. The applicant pays the Second Schedule inspection fee, which the help file prints as $6,000. FAQ 98 matches the rule: inspection is not a step the CLA must take on every file.¹²³ Budget the $6,000 as a contingent government fee, not as a consultant's travel estimate and not as a fee that is always charged.

Rule 36(1) is the grant clock: the CLA may grant Form MD-15, or reject with reasons, within nine months from the date of application, after examining the documents and any inspection report. FAQ 97 says the same nine months, provided the documents are satisfactory.¹³ A consultancy's three-to-six-month experience is not the legal clock. A contract that promises delivery on a three-month licence is promising something the rule does not promise. The nine months also is not a guarantee that a deficient file will be granted on day 270. The proviso in the FAQ is that the documents are found satisfactory.

Rule 37 is the validity rule, and it is where many commercial pages are still wrong. A licence granted under Rule 36(1) remains valid in perpetuity unless cancelled or surrendered, provided the authorised agent deposits the retention fee for each overseas site and each licensed device after every five years from issue. FAQ 55 says the same for an import licence, a manufacturing licence, and a registration certificate.¹³ There is no five-year expiry and no renewal form that replaces the licence. FAQ 141 adds the operational protection: if the retention application and fee are submitted on time, and the acknowledgement has not yet arrived, the licence is deemed valid and the product may still be marketed.

The late window is in the proviso to Rule 37, not in a Rule 37(2). The CLA may allow the retention fee after the due date but before ninety days have expired, with a late fee at 2 percent per month. If the fee is not deposited in that period, the licence is deemed to have been cancelled.³ Do not replace that ninety-day import proviso with a longer window taken from manufacturing-licence commentary. The consolidated import-licence text checked for this article is ninety days. After deemed cancellation, the practical route back is a new Form MD-14. The rule does not describe a revival button.

Post-approval changes are Rule 38, not a second import licence, unless a fresh-licence trigger in the previous section applies. For a major change specified in the Sixth Schedule, the agent needs prior approval. The CLA indicates approval or rejection within sixty days. If no communication arrives in that time, Rule 38(1)(vi) says the change is deemed approved. A minor change specified in the Sixth Schedule is notified within thirty days after it takes effect and does not need prior approval. FAQ 136 and FAQ 137 match those two clocks for import.¹³ The sixty days is the authority's response time, with silence treated as approval. It is not an instruction that the applicant must obtain a signed letter before day 60 or start again.

Can a CE mark, a 510(k), or an NMPA registration replace the Indian licence?

No instrument below replaces Form MD-15 or the Class A registration number. FAQ 88 and FAQ 89 still require the Indian filing and the Second Schedule fee. What a foreign approval can change is the clinical-investigation step, and only on the terms of the specific rule.¹

Read Rule 36(3), (4), and (5) before reading the no-predicate waiver. They are the ordinary import path.³

• Rule 36(3). Where a free-sale certificate has already been issued by the national regulatory authority, or another competent authority, of Australia, Canada, Japan, a European Union country, or the United States, the licence is granted without carrying out a clinical investigation. A CE mark printed on a label is not itself that certificate. The rule names the free-sale certificate. The United Kingdom is not named in this sub-rule. NMPA is not named.
• Rule 36(4). If the device is imported from a country other than those five, a Class C or Class D licence may be granted after safety and effectiveness are established through a clinical investigation in India under Chapter VII.
• Rule 36(5). For a Class A or Class B device from a country outside that list, the licence may be granted after safety and performance are established through published data, or through a clinical investigation in the country of origin, and a free-sale certificate from the country of origin is furnished.

China sits in Rule 36(4) and (5), not in Rule 36(3). For a sterile Class A or Class B consumable, the rule's path is published safety and performance data, or origin-country clinical investigation, plus a Chinese free-sale certificate. It is not an automatic Indian trial, and it is not a waiver of the licence. A Class C or Class D device from China is the case in which Rule 36(4) points to an Indian clinical investigation.³

The no-predicate case is Rule 63, not Rule 36. The rules define a predicate device as a device, first of its kind, already approved by the CLA for manufacture for sale or for import, with similar intended use, material of construction, and design characteristics.³ If there is no predicate, the application for permission is Form MD-26, and the permission is Form MD-27, after clinical investigation, with a fee. The further proviso says clinical-investigation results need not be submitted where the device is approved by the regulatory authorities of the United Kingdom, the United States, Australia, Canada, or Japan, has been marketed for at least two years in that country, and the CLA is satisfied with the safety, performance, and pharmacovigilance data, and both of the following are true: there is no evidence, and no theoretical possibility on existing knowledge, of a difference in behavior and performance in the Indian population; and the applicant undertakes in writing to conduct a post-marketing clinical investigation for safety and performance under a protocol the CLA approves.³ FAQ 117 states the country list and the two-year marketing test, and adds that the waiver is decided case by case in consultation with the Subject Expert Committee. The FAQ's shorter wording does not delete the two conditions in the rule.¹

An EU CE mark is on the Rule 36(3) free-sale list and is not on the Rule 63 country list. A UK approval is on the Rule 63 list and is not named in Rule 36(3). An NMPA registration is on neither list. Calling all three 'dossier evidence only' hides the one statutory difference that changes the clinical file: an EU, US, Canadian, Japanese, or Australian free-sale certificate can take clinical investigation out of the ordinary import licence. It still does not take the licence, the fee, or the Fourth Schedule out.

The free-sale certificate has its own rejection rules. FAQ 108: the certificate should state both the legal manufacturer's name and address and the actual manufacturer's name and address. FAQ 111: a certificate of exportability, meaning the product may not be freely sold in the country of origin but may be exported, is not acceptable as a free-sale certificate.¹ An export-only Chinese certificate will not fill the Rule 36(5) free-sale line. For how to read the document itself, see the guide to verifying a certificate of free sale and the guide to reading an NMPA registration certificate before it is put into an Indian file.

How is a sterile single-use device classified, and what if India disagrees with the home country?

Rule 4(3) says the Central Licensing Authority classifies medical devices by intended use and the First Schedule. The class-wise list is published on the CDSCO website and may be changed. FAQ 77 says only the CLA is competent to classify. FAQ 76 tells the reader to use the published list. FAQ 78 says that if the device is not on the list, the applicant may ask the CLA for a classification, with the label, the instructions for use, and the regulatory status in other countries.¹³ A worked example on this page is a reading of those parameters. It is not a class assigned to a VEMERIX or Medison SKU.

FAQ 93 is the mismatch rule, and its words are narrower than 'CDSCO will enforce the higher class'. If the classification in IMDRF (formerly GHTF) countries differs from the classification in India, the higher risk class may be considered by the licensing authority.¹ 'May be considered' is not an automatic regrade, and it is not triggered by energy delivery or mucosal contact unless an IMDRF country's class is actually higher. Those facts belong in the First Schedule. If the CLA does apply a higher class, the Second Schedule fee follows the class on the application, not the home-country class.

Standards are Rule 7, not Rule 43. Rule 43 is the personal-baggage and personal-use import rule. Rule 7 says the device conforms to a Bureau of Indian Standards standard, or a standard the Ministry notifies. If none is laid down, it conforms to an ISO or IEC standard, or another pharmacopoeial standard. If none of those is specified, it conforms to the manufacturer's validated standard. FAQ 25 matches the first two steps: a BIS standard, where one exists for that device, is mandatory; otherwise ISO or IEC applies. FAQ 26 adds the pharmacopoeial or validated manufacturer's standard where BIS, ISO, and IEC are silent.¹³

Two duration definitions matter before anyone picks a class. Transient use is continuous use for less than sixty minutes. Short-term use is continuous use for not less than sixty minutes and not more than thirty days.³ A circumcision ring that is intended to remain in place for several days is not a transient instrument just because the procedure itself is short.

What do the 2025 and 2026 portal changes add to a file being prepared now?

• Classification request for a device that is not on the list. The portal banner on 28 September 2026 says a risk-classification provision for medical devices has been available since 27 November 2025. CDSCO's circular list records a 5 December 2025 circular on that provision. This is the digital form of the FAQ 78 request. It does not reclassify a device that is already on the published list, and it does not replace Form MD-14.⁴⁵¹
• IVD classification dates do not match across two official surfaces. The 6 February 2026 IVD circular says the IVD module was functional from 2 February 2026. The portal banner on 28 September 2026 says the IVD provision has been available since 18 February 2026. Confirm the date on the screen you are filing. Either way, the module is for an IVD that is not already listed. This guide does not use it for a non-IVD consumable.⁴⁷
• Import Export Code. The same banner says IEC details must be added from the menu before an import-licence application, and that they are mandatory to proceed. A manufacturer that has not yet given its Indian agent an IEC-linked portal account should not expect Form MD-14 to open.⁴
• Special code. The banner also says a special-code provision has been available since 15 May 2026. That is an export-code function. It is not Form MD-15.⁴
• Procurement licences. CDSCO's circular list dated 20 November 2025 includes a circular titled as a requirement that procurement agencies obtain a licence issued by CDSCO or a State Licensing Authority when procuring medical devices. Read that circular before quoting it to a tender committee. What this page can say from the title, together with FAQ 88, is that a CE certificate or a 510(k) is not the Indian authorization a buyer is being told to ask for.⁵¹
• Subsequent importer. Use the 11 September 2025 portal provision and its checklist, as described above.⁶
• Software guidance. CDSCO's medical-device page lists a guidance document on medical device software under the 2017 rules, dated 21 July 2026. It does not open or close the Form MD-14 route for a sterile single-use device that contains no software.¹⁴

Which public tenders can a Chinese-origin line enter?

Split the buyer before you split the product. A private hospital buying for itself is not inside the General Financial Rules. A central ministry, a public enterprise, or another body covered by the 23 July 2020 Department of Expenditure order is.¹⁰

That order, F. No. 6/18/2019-PPD, inserted Rule 144(xi). A bidder from a country that shares a land border with India may bid in the procurements the order covers only if registered with the competent authority, the Registration Committee in the Department for Promotion of Industry and Internal Trade. Registration depends on political and security clearance. China shares a land border with India.¹⁰¹¹ The bidder test reaches an entity incorporated in such a country, an entity controlled or beneficially owned from there, and an Indian agent of such an entity. It is not a rule that every carton manufactured in China is ineligible, regardless of who the bidder is. An Authorised Indian Agent of a Chinese manufacturer should treat itself as possibly inside the definition and should not plan a government tender as if the order did not exist. An Indian-owned distributor that is not an agent of, and is not controlled from, a land-border country has a different question, which the order's definition has to be applied to on the facts. This page is not that legal opinion.

Private-hospital purchasing is outside that order. A valid Form MD-15, or the Class A registration number where that is the real route, is still required to import and sell. Country of origin does not, by itself, close a private formulary. Do not describe government business as closed for every Chinese-made consumable, and do not describe it as open because a private hospital has already bought the product.

Trade remedies are a separate register. On 25 June 2026 the Directorate General of Trade Remedies initiated an anti-dumping investigation, F. No. 6/19/2026-DGTR, into dialyzers originating in or exported from China PR and Malaysia. Later entries on the case page are procedural. They are not a duty order.⁸⁹ Circumcision devices, laser fibers, and wound-therapy consumables are not the product under consideration in that notice. Check the DGTR case list before a supply contract assumes that no duty exists on the actual customs heading. Do not infer a duty on a different device from the fact that an investigation into dialyzers has been opened.

Three portfolio examples, read as classification questions rather than assigned classes

These examples use VEMERIX catalogue families because that is the file a distributor of this brand would actually open. NMPA class and a CE mark are home-country facts. They are not the Indian class. No VEMERIX or Medison product is held out as CDSCO-licensed. The CLA's published list, or a classification request if the device is absent from it, is the class that goes on Form MD-14.¹

Example A: a sterile circumcision ring and a sterile circumcision anastomat

These are different devices. The circumcision ring is a single-use device supplied sterile, with an NMPA Class II registration and a CE mark on the product page. The anastomat kit is a separate single-use sterile kit, also NMPA Class II, built around a stapler rather than a ring. Putting both on one Indian licence line because they share a procedure is how a model number gets left off the endorsement.

For the ring, the First Schedule question starts with duration and with whether the device is invasive through a body orifice. If the intended continuous use is several days, the short-term body-orifice rules are the ones to read, not the transient-use rules. The registration exemption is already unavailable because the device is sterile, whatever class the CLA assigns. If the CLA assigns Class A, the import fee is $1,000 for the site and $50 for the device. If the CLA assigns Class B, those figures are $2,000 and $1,000.²³

For the anastomat, the relevant parameter is a surgically invasive device for transient use. The default in that parameter is Class B. A reusable surgical instrument is pushed to Class A. A disposable stapler is not that reusable-instrument case. Further clauses move a transient surgically invasive device up if it supplies ionising radiation, is intended to have a biological effect or to be wholly or mainly absorbed, administers a medicine in a potentially hazardous way, or contacts the central nervous system or the central circulatory system. Staples that remain in tissue are a separate question for the CLA, because implantable rules are not the same as the rule for the handpiece that fires them. Sterility, again, chooses the licence route. It does not choose Class B.³

Either device, once a class is assigned, is a Form MD-14 file: power of attorney, Fourth Schedule documents, free-sale certificate naming the legal and actual manufacturers, and the fee for that class. A Chinese free-sale certificate is tested under Rule 36(5) if the class is A or B, not under the EU limb of Rule 36(3).¹³

Example B: a 1470 nm single-use laser fiber

The fiber is Medison's NMPA-registered single-use consumable. It is used with a partner-supplied diode laser source. The NOVACURE console is not a Medison-manufactured or Medison-registered capital system, and it is not covered by the fiber's file. The fiber needs its own Indian authorization. The console, if it is imported at all, needs its own.

On the First Schedule, a transient surgically invasive device that is intended to be connected to an active device is assigned the class of that active device. An active therapeutic device intended to administer or exchange energy is Class B, and it moves to Class C if that energy may be administered in a potentially hazardous way, taking account of the nature, density, and site of the energy and the technology. Endovenous use is exactly the fact pattern in which that 'potentially hazardous' clause has to be asked. It is not a sentence that already answers Class C.³ FAQ 93 can then be asked only if an IMDRF country has actually classified the device higher than the Indian class. An NMPA Class II registration does not answer either question.

The fee follows the class the CLA assigns. Class B is $2,000 plus $1,000. Class C is $3,000 plus $1,500. Quoting one of those pairs in a distribution agreement, before the list or a classification request, is quoting a hypothetical.²

Example C: a non-sterile post-operative garment

Circum-CARE pants are a non-sterile protective garment for after circumcision or other outer-genital surgery, with an NMPA Class I filing on the product page. The First Schedule assigns a non-invasive device that only contacts intact skin, and that is not caught by the earlier non-invasive rules, to Class A. If it is also non-measuring, and if the published list does not place it higher, the import route is the registration number rather than Form MD-15, and FAQ 71 says the fee is nil.¹³ That is a parameter reading. It is not a statement that the CLA has already registered this garment, and it is not a statement that upload of an ISO 13485 certificate is the statutory act that creates the number. FAQ 69 requires the portal information, Chapter VI labeling, and applicable standards. Use the current portal form for the upload list.

If a buyer asks for the garment to be supplied sterile, the registration exemption is gone even if the class stays Class A.¹

How do you verify an Indian licence before signing a distribution agreement?

Ask for documents that the rules and the FAQ actually describe. Do not accept a class label or a portal nickname as a substitute.

• The instrument matches the route. A sterile device should come with Form MD-15, or with a filed Form MD-14 and a clear statement that the licence is not yet granted. A registration number answers only the Class A non-sterile, non-measuring case.¹
• Names and addresses match. The legal manufacturer and the actual site on the licence should match the ISO 13485 certificate, the free-sale certificate, and the carton. FAQ 108 is the same discipline for the free-sale certificate.¹
• The model list is the model list. Brand and model endorsements are what the fee was paid for. A family name is not an endorsement of every diameter.
• Retention is in date. If the grant was more than five years ago, ask for the retention payment and the acknowledgement. FAQ 141 covers a timely application that is still being processed. The ninety-day late proviso is not a reason to ignore a missed payment.¹³
• The agent can legally hold the file. Manufacturing licence, wholesale licence, or Form MD-42, plus the power of attorney. A device-only trader does not satisfy this by waving Form 20B if FAQ 144 says that form is not the device-only path.¹
• The buyer is the buyer you think. For a covered public tender, ask whether the bidder falls inside Rule 144(xi) and, if so, whether DPIIT registration exists. A private hospital purchase does not ask that question.¹⁰

Where VEMERIX fits, and where due diligence still begins

VEMERIX is the international brand of Weihai Medison Medical Equipment Co., Ltd., positioned as a Minimally Invasive Surgery Total Solution Platform serving urology, vascular surgery and perioperative care.

VEMERIX does not hold, and does not claim, a CDSCO import licence or an Indian registration number for the products discussed here. Under Rule 34 the Indian authorised agent holds the application. A distributor, a hospital group, or another Indian entity that already has a manufacturing licence, a wholesale licence, or Form MD-42 is the party that files Form MD-14.³

What the manufacturer can put on the table is the material that agent needs in order to build the Fourth Schedule file, not a file that has already been granted in India. For the catalogue families above, that material is the kind of technical and quality evidence the product pages already describe: the NMPA registration identity, sterility and packaging information where the device is supplied sterile, and the free-sale documents needed to name both the legal manufacturer and the actual site. An Indian partner still has to map that material onto the Fourth Schedule, pay the Second Schedule fee, and live with the class the CLA assigns. ISO 10993 and ISO 11135 reports, where they exist for a sterile device, are evidence in that dossier. They are not an Indian licence. Rule 47 is a separate import condition on residual shelf life: under ninety days of labeled shelf life, at least 40 percent must remain; from ninety days to one year, at least 50 percent; over one year, at least 60 percent, unless a longer shelf life has been justified to the CLA. A tender that asks for 75 or 80 percent remaining is a different document. The comparison is in the note on residual shelf life in sterile-device tenders.³

The same families are already discussed for other markets in the Brazil placement guide and the Mexico placement guide. An NMPA class does not travel. Neither does a CE mark. The Indian conversation starts with the route in Table 1, the holder test, and the verification block above. Manufacturing controls are described on the quality page. A distributor that wants to be the authorised agent starts at contact, with the model list and the buyer type, private or public, stated up front.

Frequently asked questions

Does a CE mark or a 510(k) let the device into India? No. Both can support the dossier. A free-sale certificate from the United States, or from an EU competent authority, can remove the clinical-investigation step under Rule 36(3). The Form MD-14 application, the fee, and Form MD-15 remain.³

Is MD-15 valid for five years? No. Rule 37 and FAQ 55 keep it valid until suspension, cancellation, or surrender, if the retention fee is paid every five years. The late deposit window is ninety days, then deemed cancellation.¹³

Can the foreign manufacturer hold the licence? No. Rule 34 requires an Indian authorised agent that already holds a manufacturing licence or a wholesale licence under the rules. FAQ 90 also accepts Form MD-42. FAQ 144 says a device-only trader obtains MD-42 rather than Form 20B, 21B, or 21C.¹³

Do all Class A devices avoid an import licence? No. Only Class A devices that are both non-sterile and non-measuring. A sterile Class A device is still Class A, and it still needs Form MD-15, at the Class A fee.¹²

What if India classifies the device higher than China does? FAQ 93 says the higher class may be considered when an IMDRF country's class differs from India's. It does not require the CLA to adopt the foreign class, and an NMPA Class II registration is not an IMDRF classification.¹

Can a second Indian distributor import the same device? Yes. FAQ 94 allows more than one agent. From 11 September 2025 the subsequent agent uses the dedicated portal provision and its checklist. FAQ 95 still describes the documents, including the manufacturer's undertaking that the master files are unchanged, and the fee is still due.¹⁶

Is a certificate of exportability enough? No. FAQ 111 rejects it as a free-sale certificate. The device has to be freely sold in the country of origin, and FAQ 108 expects both the legal and the actual manufacturer on the certificate.¹

Can a Chinese manufacturer bid in an Indian government hospital tender? Only if the bidder is outside Rule 144(xi), or is registered with the DPIIT committee. An Indian agent of a Chinese manufacturer may be inside the bidder definition. A private hospital's own purchase is not that rule. The product still needs its Indian import authorization.¹¹⁰

Has the 2026 drugs and devices bill replaced the 2017 rules? No. Trade reporting describes a draft sent to other ministries, and a letter of 8 August 2026 from eleven associations asking for a separate devices law. The draft is not in force.¹²¹³

Is any VEMERIX product CDSCO-licensed? No. Market entry starts when an eligible Indian entity files. The manufacturer's NMPA registrations and CE marks, where the product page states them, are home-country facts for that file. They are not Form MD-15.