Background
The Medical Devices Rules, 2017 were issued under the Drugs and Cosmetics Act, 1940 to establish a dedicated regulatory system for medical devices in India. Prior to these rules, most devices were treated as drugs, creating gaps in licensing, quality control, and post-market oversight. The rules introduced risk-based classification (Class A to D), licensing for manufacture/import/sale, quality management requirements aligned to ISO 13485, and provisions for clinical performance and vigilance.
Applicability
These Rules shall be applicable to:
Compliance Requirements under the Rules
Manufacturers or importers must maintain records of production, import, sales, and distribution. They must provide records, labels, and usage instructions when requested by Licensing Authorities, who may verify them anytime and investigate quality or safety issues.
Any person aggrieved by an order of the State or Central Licensing Authority may file an appeal to the respective Government within 45 days of receiving the order. After giving a hearing, the Government may confirm, reverse, or modify the order.
The State Licensing Authority shall either grant a licence in Form MD-5 or MD-6 for Class A (excluding non-sterile and non-measuring) and Class B medical devices, or reject the application with written reasons if requirements are not met within 45 days.
Rule 20- To manufacture Class A (excluding non-sterile and non-measuring) or Class B medical devices, an application must be submitted online in Form MD-3 or MD-4 with the prescribed fee, documents, and an undertaking of Quality Management System compliance.
If satisfied that all rules are met, the Central Licensing Authority shall, within 45 days of receiving the inspection report, grant a licence in Form MD-9 or a loan licence in Form MD-10, or reject the application with written reasons.
To manufacture Class C or Class D medical devices for sale or distribution, an application must be submitted to the Central Licensing Authority through the designated online portal of the Central Government. The application should be made in Form MD-7 for a licence or Form MD-8 for a loan licence, as applicable.
After receiving a licence in Form MD-5/6/9/10, the holder must: show the licence on request; report serious adverse events within 15 days; get approval for major changes; inform minor changes within 30 days; and test each batch before release as per Rule 83(3).
The licence holder must:
(i) withdraw and, where possible, recall non-conforming device lots as directed by the authority;
(ii) maintain an audit book in Form MD-11 for inspection;
(iii) keep one sample unit from each batch of invasive or diagnostic device for 180 days after expiry;
(iv) maintain manufacturing and sales records for inspection;
(v) ensure each device sold includes a package insert or user manual, if applicable;
(vi) conduct manufacturing/testing under qualified technical supervision;
(vii) inform the authority if manufacturing is stopped or the site is closed for 30 days or more.
If a licence or loan licence is suspended or cancelled, the licensee may appeal to the State or Central Government within 45 days of receiving the order. After a hearing, the authority may confirm, reverse, or modify the order.
The Central Licensing Authority shall, within 30 days of receiving the application, either grant a test licence in Form MD-13 if all requirements are met, or reject the application with written reasons after necessary enquiry, if any.
A small quantity of Class A (excluding non-sterile and non-measuring), Class B, Class C, or Class D medical devices may be manufactured for clinical investigations, testing, evaluation, examination, demonstration, or training purposes. For this, an application must be submitted to the Central Licensing Authority in Form MD-12, along with the applicable fee as specified in the Second Schedule.
Licence holder must maintain an audit/inspection book in Form MD-11 for recording observations and non-conformities by the Notified Body or Medical Device Officer during inspections.
The licence holder must keep at least one unit of sample from each batch of invasive medical device and in vitro diagnostic medical device manufactured, for reference, for 180 days after the batch’s expiry date.
The licensee must maintain records of the quantity of products manufactured under the test licence.
A Form MD-13 licence under Rule 31 is subject to conditions: use is limited to clinical investigation, testing, or training; Medical Device Officers may inspect the premises; and records of device quantity, testing, and disposal must be maintained.
A licensee, whose licence has been cancelled, may appeal to the Central Government within forty-five days from the date of the order.
The Central Licensing Authority shall, within nine months of receiving the application under Rule 34(1), grant a licence in Form MD-15 or reject the application with written reasons, based on the submitted documents and inspection report, if applicable.
Rule 34- An authorised agent holding a manufacturing or wholesale licence for sale or distribution, or a registration certificate in Form MD-42 under these rules, must apply for an import licence for medical devices through the designated online portal of the Ministry of Health and Family Welfare. The application must be submitted to the Central Licensing Authority in Form MD-14 to obtain the import licence.
If the application is rejected, the applicant may appeal to the Central Government within 45 days. The Government shall review the matter and pass an order within 90 days from the date of appeal.
The licensee shall maintain complete, accurate, and current records of the quantity of each product imported under the import licence. These records must capture all essential details, including date of import, description of goods, quantity, source details, and relevant import documentation. The data should be maintained in an organised format to allow easy retrieval and verification during inspections by regulatory authorities. Proper record-keeping ensures compliance with the terms of the import licence, facilitates transparency in trade, supports traceability in case of product recalls or quality concerns, and serves as evidence in meeting statutory obligations. Maintaining such detailed and accurate records is essential for regulatory accountability and smooth import operations.
If there is a change in the constitution of a licensee after the licence is granted under Rule 36(1), a fresh application for licence must be submitted under Rule 34(1) within 180 days from the date of such change.
The existing licence shall remain valid until the Central Licensing Authority either issues a fresh licence or rejects the application, whichever occurs earlier.
The Central Licensing Authority shall, within 30 days of receiving the application under Rule 40(2), grant a test licence in Form MD-17 or reject the application with written reasons, after necessary enquiry and confirming compliance with the rules.
A person intending to import a medical device for the purpose of test, evaluation, demonstration, or training under sub-rule (1) must apply to the Central Licensing Authority for an import licence in Form MD-16. The application must be submitted along with the applicable fee as specified in the Second Schedule.
In cases where the medical device is required to be taken to any place other than the ones mentioned in the test licence, the Central Licensing Authority shall be informed in writing before doing so.
The consignment of medical device shall be accompanied by an invoice or statement showing the name and quantity of the medical device
The holder of the test licence must maintain records of all activities, including the manufacturer’s name, quantity imported, and date of import.
A person aggrieved by an order of the Central Licensing Authority may appeal to the Central Government within 30 days. After necessary enquiry and hearing, the Government may pass an appropriate order.
If a manufacturer or licensee fails to comply with any import licence conditions or provisions of the Act or rules, the Central Licensing Authority may, after giving an opportunity to show cause, issue a written order to cancel or suspend the licence fully or partly for a specified period. It may also direct the licensee to stop the import, sale, or distribution of the medical device and order its destruction, along with the available stock, in the presence of an authorised officer if non-compliance is confirmed.
Medical device packaging must have indelible labels showing the device name, identifying details and use, manufacturer’s name and address, net quantity and unit count, and the month/year of manufacture and expiry or shelf life.
The following details must be printed in indelible ink on the label, shelf pack, or outer cover of a medical device, as applicable:
1. Indication if the device contains medicinal or biological substances, where required
2. Batch or lot number, clearly marked as “Lot No.”, “Batch No.”, or similar
3. Special storage or handling conditions, if applicable
4. Sterile status and sterilisation method, if the device is supplied sterile
5. Relevant warnings or precautions for user safety
6. Single Use” label, if the device is meant for one-time use
7. Physician’s Sample—Not to be sold” label, if the device is a free sample
8. Manufacturing licence number for domestic devices, labelled as “Mfg. Lic. No.” or similar
9. For imported devices: import licence number, name and address of the importer, actual manufacturing site, and date of manufacture (may be stickered if not pre-printed)
Export labels must meet the importing country’s laws but must also clearly show the following details-
1. Name of the device
2. Batch/Lot/Serial number
3. Expiry date, if applicable
4. Manufacturer’s name and address, and manufacturing site address
5. Licence number
6. International symbols as needed
The Central Government may order that all approved medical devices for sale, distribution, or import must carry a unique device identification as specified in the order.
Medical devices should have a shelf life of up to 60 months from the manufacturing month, unless the manufacturer provides valid proof to the Central Licensing Authority to justify a longer shelf life.
Devices for clinical investigation, testing, demo, or training must be labelled with: product name/code, batch/lot/serial number, manufacture and use-before dates, storage conditions, manufacturer’s name and address, and intended purpose.
The Central Licensing Authority may approve or reject, with reasons, an application to import or manufacture a medical device without a predicate, within 120 days or an extended period of up to 30 days, using Form MD-27.
Unless stated otherwise, to import or manufacture a medical device without a predicate, the applicant must submit Form MD-26 to the Central Licensing Authority after completing clinical investigation under Chapter VII. The application can be made by the authorized agent (for imports) or the manufacturer, and must include the required fee as per the Second Schedule and information specified in Part IV of the Fourth Schedule.
The Central Licensing Authority may approve or reject, with written reasons, an application to import or manufacture a new in vitro diagnostic device in Form MD-29 within 90 days or an extended period of up to 30 days from the application date.
To import or manufacture a new in vitro diagnostic medical device, an application must be submitted to the Central Licensing Authority in Form MD-28. This can be done by an authorized agent (for imports) or by the manufacturer. The application must include the prescribed fee as per the Second Schedule and the required information as specified in Part IV of the Fourth Schedule.
Permission is subject to:
(a) Device must match submitted specs
(b) MD-27 holder to submit PSURs every 6 months for 2 years, then annually for 2 more
(c) Launch date must be informed
(d) Serious adverse events to be reported within 15 days
Medical device testing laboratories must obtain registration under Form MD-40 from the Central Licensing Authority to legally conduct testing or evaluation of medical devices on behalf of manufacturers. Before granting registration, CDSCO will inspect the laboratory premises through a designated Medical Device Officer, with or without an expert in the relevant field. The officer will submit a detailed report with findings and recommendations. Based on this, the Central Licensing Authority will assess whether the lab has adequate infrastructure, qualified personnel, suitable equipment, and the ability to meet recognised standards. If satisfied, registration in Form MD-40 is granted within 45 days of the application. To retain registration, the lab must continue to maintain adequate facilities, employ responsible and qualified personnel, and comply with all applicable testing standards and regulatory conditions as prescribed under the rules.
The State Licensing Authority shall issue Form MD-42 or reject the application with written reasons within 10 days of receiving it, after verifying compliance with the rules.
Anyone intending to sell, stock, exhibit, offer for sale, or distribute a medical device, including in vitro diagnostic devices, must apply to the State Licensing Authority using Form MD-41 to obtain a registration certificate for these activities.
Conditions for registration certificate:
1. Display certificate visibly
2. Ensure proper storage and space
3. Maintain required temperature and lighting
4. Buy from licensed sources only
5. Keep detailed purchase/sale records
6. Allow inspection and sampling
7. Preserve records for 2 years
8. Maintain Form MD-43 inspection book
A registration holder whose certificate is suspended or cancelled may appeal to the State Government within 45 days of receiving the order. The State Government will confirm, reverse, or modify the order after a hearing, with written reasons.
Despite the Drugs and Cosmetics Rules, 1945, any person with a valid sale licence or Form MD-42 registration may supply invasive implantable medical devices to hospitals for patients via a delivery challan. Any person with a valid sale licence or Form MD-42 registration may supply invasive implantable medical devices to hospitals for patients via a delivery challan.
If a manufacturer or agent believes a medical device may pose health risks, they must immediately withdraw it from the market and patients, state the reasons, and inform the competent authority with full details.
Penalty & Punishment
Whoever without reasonable cause or excuse, contravenes the provisions of section 18B shall be punishable with imprisonment for a term which may extend to one year or 3[with fine which shall not be less than twenty thousand rupees or with both
Section 27(b) – Activities done without a valid licence-
without a valid licence as required under clause (c) of section 18, shall be punishable with imprisonment for a term which shall 1 [not be less than three years but which may extend to five years and with fine which shall not be less than one lakh rupees or three times the value of the drugs confiscated, whichever is more
Section 30-
Under clause (b) of section 27 is again convicted of an offence under that clause, shall be punishable with imprisonment for a term which shall not be less than seven years but which may extend to ten years and with fine which shall not be less than two lakh rupees
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