Registration for sale of Medical Devices: Procedure and conditions

Make an application in Form MD-41 to the State Licensing Authority of the concerned state along with all relevant documents mentioned below

Rakesh Dahiya

December 24, 2022

2822

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Rakesh Dahiya

SDCO Cum Licensing Authority |
Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com

Registration for sale of Medical Devices: Procedure and conditions

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Govt of India has issued notification No. GSR 754(E) dt 30-09-2022 for the registration certificate to sell, stock, exhibit, or offer for sale or distribute a medical device including in vitro diagnostic medical device

Download notification No. GSR 754(E) dt 30-09-2022

Requirement for registration for the sale of Medical Devices

Application of Form MD-41

(Make an application in Form MD-41 to the State Licensing Authority of the concerned state along with all relevant documents mentioned below)

Download Form MD-41, click the below link:

Form-MD-41

The application shall be accompanied with:

A fee of Rs. 3000/-;

Self-certificate of compliance with respect to Good Distribution Compliance;

Details of the applicant or firm including its constitution, along with identification proof, such as an Aadhar card or PAN card;

Documentary evidence in respect of ownership or occupancy on rental of the premises;

Brief description of other activities carried out by the applicant, namely, storage of drugs, medical items, food products, stationeries, etc., or any other activities carried out by the applicant in the said premises; and

An undertaking to the effect that the storage requirements to sell, stock, exhibit or offer for sale or distribute a medical device will be complied with.

Details of competent technical staff, under whose direction and supervision the sales activity of medical devices shall be undertaken:

Qualification of Technical Staff

The technical staff shall possess the following educational qualification and experience, namely:

Hold a degree from a recognized University/Institution; or
Is a registered pharmacist; or
Has passed the intermediate examination or its equivalent examination from a recognized Board with one-year experience in dealing with the sale of medical devices;

Apply online on for registraion of Medical Devices

Grant of registration certificate in Form MD-42

The State Licensing Authority shall, after scrutiny of documents and being satisfied that the
requirements of these rules have been complied with, grant a registration certificate in Form MD-42.

Download Form MD-42, click the below link

Form-MD-42

Conditions of registration certificate

(1) The registration certificate granted under rule 87A shall be displayed at a prominent place on the premises and visible to the public.

(2) The registration certificate holder shall provide adequate space and proper storage conditions for the storage of the medical devices.

(3) The registration certificate holder shall maintain the requisite temperature and lighting as per the requirements of such medical devices.

(4) The medical devices shall be purchased only from an importer or licensed manufacturer or registered or licensed entity.

(5) Separate records, in the form of invoice or register or electronic details including software of purchases and sales of medical devices showing the names and quantities of such medical devices, names and addresses of the manufacturers or importers, batch number or lot number and expiry date (if applicable) shall be maintained.

(6) The records referred to in sub-rule (5) shall be open to inspection by a Medical Device Officer appointed under the sub-rule (2) of rule 18, who may, if necessary, make inquiries about purchases and sale of the medical devices and may also take samples for testing.

(7) All registers and records mentioned under these rules, shall be preserved for a period of not less than two years from the last entry, therein.

(8) The registration certificate holder shall maintain an inspection book in Form MD-43 to enable the Medical Devices Officer to record his observations and defects noticed.

Download Form MD-43, click the below link:

Form-MD-43

Validity of registration certificate

A registration certificate issued in Form MD-42 shall remain valid in perpetuity, subject to payment of the registration certificate retention fee as specified in the Second Schedule, before completion of the period of five years from the date of its issue, unless, it is suspended or canceled by State Licensing Authority

Fee structure: All types of drugs licenses:

Download the pdf file for the license fee structure for all licenses under the Drugs and Cosmetics Act 1940 and the Rule framed thereunder. Click below link

License fee structure for all licenses

Fees for various kinds of drugs Licenses under Drugs and Cosmetics Act 1940 & Rules 1945

Types of Licenses	Application Form	License on Form	Fee	Renewal / Retention fee	Late fee	Duplicate license	Fee per item
Drug Sale Licenses
Whole Sale	19	20-B & 21-B	3000/-	3000/-	2%	300/-	–
Retail sale	19	20 & 21	-do-	-do-	-do-	-do-	–
Homeopathic (WSDL)	19-B	20-D	250/-	20-E	50/-	150/-	–
Homeopathic (RSDL)	19-B	20-C	250/-	20-E	50/-	150/-	–
Sch. X (WSDL)	19-C	20-G	500/-	500/-	2%	150/-	–
Sch. X (RSDL)	19-C	20-F	500/-	500/-	2%	150/-	–
Drug Manufacturing Licenses
Manufacturing (Non- Biological)	24	25	7500/-	7500/-	2%	1000/-	300/-
Manufacturing (Biological)	27	28	7500/-	7500/-	2%	1000/-	300/-
Manufacturing Schedule X	24 F	25 F	7500/-	7500/-	2%	1000/-	300/-
License for Test / Analysis	29	30	250/-	Valid for 3 years. Renewal for 1 year	–	–	–
Loan License (Biological)	27-A	28-B	7500/-	7500/-	2%	No	300/-
Loan License (Non- Biological)	24-A	25-B	7500/-	7500/-	2%	No	300/-
LVP	27-D	28-D	7500/-	7500/-	2%	No	300/-
Cosmetics Manufacturing Licenses
Manufacturing	COS 5	COS 8	10,000/	10,000/-	2%	–	500/-
Loan License	COS 6	COS 9	10,000/	10,000	2%		500/-
Laboratory	COS 22	COS 23	1,000/-	1,000/-	2%	100/-	–
Additional Section	–	–	10,000/	–	–	–	–
Free Sale	–	–	No fee	–	–	–	–
Medical Devices Manufacturing Licenses
Medical Devices (A& B)	MD-3	MD-5	5000/-	5000/-	2%	–	500/-
Medical Devices (Loan License) (A& B)	MD-4	MD-6	5000/-	5000/-	2%	–	500/-
Medical Devices (C& D)	MD-7	MD-8	50,000/-	50,000/-	2%	–	1,000/-
Medical Devices Loan License (C& D)	MD-9	MD-10	50,000/-	50,000/-	2%	–	1,000/-
Registration of Medical Devices Laboratory	MD-39	MD-40	20,000/-	20,000/-	2%	–	–
Sale License	MD-41	MD-42	3,000/-	3,000/-	2%	–	–
Free Sale certificate			1,000/- for each category
Other Licenses
Blood Centre	27-C	28-C	7500/-	26-G	1000/-	No	300/-
Homeopathic Mfg License	24-C	25-C	300/-	26-C	100/-	50/-	50/-
Approval of Commercial testing Lab	36	37	7500/-	7500/-	2%	–	–
Repacking Non-Biological	24-B	25-B	700/-	700/-	2%	1000/-	100/-