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Applicability

These Rules shall be applicable to:

1. Establishment engaged in sale/distribution of medical device
2. Importer of medical device
3. Laboratory carrying out Test / Evaluation for Manufacturer

Compliance Requirements under the Rules

1. Maintenance of records by Manufacturers/Importers (Rule 19L)

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.

2. Appeal Against Registration Cancellation/Suspension for Class A Nonsterile Medical Devices (Rule 19M)

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.

3. Form MD-5/MD-6: Licence for Manufacturing Class A/B Medical Devices (Excl. Nonsterile/Non-measuring) (Rule 20 (4) / (6))

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.

4. Form MD-9/MD-10: Licence to Manufacture Class C/D Medical Devices for Sale or Distribution (Rule 25)

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.

5. Conditions for manufacturing licence or loan licence (Rule 26)

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.

6. Appeal against cancellation or suspension of license granted in Form MD-5 /MD-6 / MD-9 / MD-10 (Rule 30)

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.

7. Form MD-13: Licence to manufacture medical devices for clinical investigation or testing purposes (Rule 31)

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.

8. Maintain Audit/Inspection Book in Form MD-11 (Rule 26)

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.

9. Maintain Reference Samples of Invasive & In Vitro Diagnostic Medical Devices
   (Rule 26)

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.

10. Maintain Record of Quantity Manufactured Under Test Licence (Rule 31)

The licensee must maintain records of the quantity of products manufactured under the test licence.

11. Conditions for License granted in Form MD-13 (Rule 32)

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.

12. Appeal against cancellation of license granted in Form MD-13 (Rule 33)

A licensee, whose licence has been cancelled, may appeal to the Central Government within forty-five days from the date of the order.

13. Form MD-15: Licence to Import Medical Device (Rule 36)

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.

14. Appeal against rejection of application for import license (Rule 36)

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.

15. Conditions for License granted in Form MD-15 (Rule 38)

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.

16. Intimation for change in constitution (Rule 39)

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.

17. Form MD-17 – Test Licence for Import of Medical Devices for Testing, Evaluation.
    (Rule 41)

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.

18. Consignment of Medical Device shall be accompanied by Invoice (Rule 38 (ix))

The consignment of medical device shall be accompanied by an invoice or statement showing the name and quantity of the medical device

19. Maintenance of records for activities under MD-17 (Rule 41)

The holder of the test licence must maintain records of all activities, including the manufacturer’s name, quantity imported, and date of import.

20. Appeal against suspension and cancellation of Import License (Rule 43A)

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.

21. Labelling requirements for medical device (Rule 44)

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)

22. Export Labelling Requirements for Medical Devices as per Importing Country Laws
    (Rule 45)

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

23. Unique device identification of medical device (Rule 46)

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.

24. Shelf Life of Medical Devices Capped at 60 Months Unless Approved by Licensing Authority (Rule 47)

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.

25. Labelling Requirements for Devices Used in Clinical Investigation, Testing, Demo, or Training (Rule 48)

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.

26. Form MD-27: Permission to Import/Manufacture Medical Devices which does not have Predicate Device (Rule 63)

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.

27. Form MD-29- Permission to import or manufacture new in vitro diagnostic medical device (Rule 64)

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.

28. Conditions for the License granted in Form MD -27 & MD -29 (Rule 65)

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

29. Form MD-40: Registration Certificate for Medical Device Testing Laboratories for Manufacturer (Rule 83(3))

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.

30. Form MD- 42: Certificate to sell/stock/exhibit/sale/distribute medical device incl. vitro diagnostic (Rule 87)

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.

31. Conditions for certificate granted under MD-42 ( Rule 87B)

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

32. Appeal against suspension or cancellation of certificate granted in Form MD-42 (Rule 87D)

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.

33. Supply using delivery challan (Rule 88)

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.

34. Recall of Medical Device (Rule 89)

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.

1. If a manufacturer or authorised agent believes that a medical device in the market may be unsafe for patients, they must immediately inform and cooperate with the competent authority.
2. The manufacturer, importer, or authorised agent must also report actions taken to reduce patient risk and must not prevent or discourage anyone from cooperating with the competent authorities, as per the Act and rules, if such cooperation can help prevent, reduce, or eliminate risks from the device.