Medical device manufacturers must register under the MDR 2017 to manufacture medical products. The Medical Device Rule 2017 states that an application needs to be submitted on the Sugam Portal to get manufacturing permission for class C and Class D medical devices. 

If a Class C or Class D medical device is being manufactured, the manufacturer will need to apply for permission for a manufacturing license to the Central Licensing Authority (i.e., CDSCO).

Class C Medical Devices Classification

The Classification System of Medical Device Rules, 2017, as the below medical devices in Class C.

Non-invasive medical equipment for channeling or stocking substances referred to in sub-clause shall be assigned Class C if it's a blood bag that does not contain a medicine product.

Non-invasive medical equipment for the modification of compositions of substances that are subject to sub-clause(b) shall be assigned Class C if it's intended for altering the biological or chemical makeup of blood, other body liquids, or other liquids for infusion into a body.

Sub-clause (b) applies to invasive medical devices (body orifices) for long-term usage. If it is intended for long-term use, an invasive medical device (body orifice) shall be assigned Class C.

Transient surgically invasive medical equipment shall be assigned the same classification as the active medical device it is meant to connect.

Short-term surgically invasive medical equipment Subject to subclause (c), Class C will be assigned to any device that is intended for a chemical change in a body or for the administration of any medical product or the supply of energy in ionising radio radiation.

Class C shall be assigned to surgically invasive medical equipment and implantable medical device for long-term usage subject to sub-clauses b, c, and d.

Class C shall be given to an active therapeutic medical instrument if it is intended to control, monitor, or directly influence the performance of a Class A active therapeutic device.

Class C shall be given to active diagnostic medical devices, as defined in sub-clause(a) if they are intended for monitoring.

If a medical device is used for contraception or to prevent the transmission of any sexually transmissible disease, it shall be classified as Class C.

Class D Medical Devices Classification

The medical device rules 2017 have the following medical devices classified under Class D.

If a surgically invasive medical device is for temporary use, it will be classified as Class D under the classification system. This applies if it is specifically intended to be in direct contact with the central nervous system or to diagnose, monitor, or correct a defect in the heart of central circulatory systems.

If a surgically invasive medical device is for short-term use, it will be classified as Class D if it has a biological effect, or is wholly, mainly, or primarily absorbed by the body, or to be used for diagnosis, monitoring, or correction of a defect in the heart or central circulatory system via direct contact with those parts.

This new classification will be applied to implantable medical devices as well as surgically invasive medical equipment for long-term use. It is only allowed to be in direct contact with the heart, central circulatory system, or central nervous system.

Sub-clause (b), medical devices that incorporate medicinal products shall be classified as Class D. If it includes an integral part of a substance, it may be considered a medicinal product. It is also liable to act upon a human body with an action that is ancillary.

If medical devices that incorporate animal or human cells, tissues, or derivatives are subject to sub-clause b, they will be assigned to Class D if they are made from, or incorporate, cells, tissues, derivatives of cells or tissue, or any combination thereof, which have been or become non-viable.

If it is an implantable or invasive medical device for long-term use, medical devices for contraceptive purposes referred to under clause (a) shall be assigned Class D.

Process To Get Manufacturing Permission for Class C And D Medical Device

Step 1 - Application for Manufacturing Licence

The applicant must submit an online application at the CDSCO portal CDscomdonline.gov.in. Fill out the form MD-7 for a license to be issued on MD-9 or as required by the Medical Device Rules. Also, include the necessary documents and fees.

Upload mandatory documents with the application form for class C and Class D medical device manufacturing permission -

1. Covering Letter

2. Application Form

3. Receipt challan fees

4. Incorporation of firm

a. Partnership deed/ Memorandum and Article of Association

b. Declaration of the Proprietor/ Partners/ Director(s),/ Managing Director

c. List of all Partners/ Directors with their addresses and complete postal/residence addresses.

5. Documents of site ownership / Tenancy agreement

6. Plant Master File (as per Appendix I of Part III, fourth schedule).

Other than the information required under appendix 1 of Part III, the fourth schedule, you should also submit the following documents:

a. Declaration of Manufacturing Chemist.

b. Declaration of Analytical Chemist.

c. Documents proving educational qualifications, experience, and approval certificates for the proposed Manufacturing Chemist & Analytical Chemist; Appointment letter; ID proof.

d. Registration through District Industries Centre

e. Consent of Rajasthan State Pollution Control Board to establish and consent to operate.

7. Device Master File for each product (as per appendix I/appendix III of the Fourth Schedule)

8. Performance Evaluation Report (if relevant)

9. If applicable, a copy of the Test License

10. Assure that the manufacturing location is in compliance with the Fifth Schedule.

Step 2 - Application review

Any discrepancy/deficit should be reported. Once the applicant has replied to their query, further action is taken. If the application is deemed in order, it can be submitted for inspection of factory premises by a notified entity as per Medical Device Rules.

Step 3: Application Audit

Audit of applicant premises by CDSCO. The applicant will rectify any non-compliances.

Step 4 - Audit Results

The audit report will be received and will be reviewed. If it is satisfactory, it will then be sent on to the next stage.

Step 5 - Products Scrutiny

The application to manufacture class C & class D medical devices will be reviewed and granted a license if the details of the product are in conformity with the norms.

Step 6 - Grant of License

Class C and Class D medical device manufacturing permission will be granted when all conditions have been met.

Anybody who would like to manufacture Class C & D Medical Devices may submit Form MD-7 to request permission. The CDSCO reviews your application. A Notified body may inspect the manufacturing site. Medical Device Officers might also inspect it, either with or without an engineer. CDSCO can issue the MD-9 license upon this basis.

CliniExperts serves as India's authorized agent for medical devices. It holds a valid Drug Wholesale License and has a strong position in Indian Healthcare. CliniExperts offers expert support for all aspects of the application process, including the submission and processing of Form MD-7. These licenses will be used to distribute or manufacture Class C and D medical devices.