“87A.
Registration certificate to sell, stock, exhibit or offer for sale or distribute a medi
SR.NO CHECKPOINTS REMARKS
3000 (Registration certificate for sale of
medical devices ) AND 3000 FOR Retention fee
for registration
certificate for sale of medical
1 fees specified in Second Schedule; devices
self certificate of compliance with
2 respect to Good Distribution Compliance Template
details of the applicant or firm including Partnership deed- incase of partnership, cin in
its constitution, along with identification case of pvt ltd , for properietor ship company
3 proof, such as, Aadhar card or PAN card declarartion of same by proprietor
documentary evidence in respect of
ownership or occupancy on rental of the rent aggrement in case of rented premises ,
4 premises registrastion copy in case ownership of building
List of employees with their educational
qualification and work exp for following
requirments
a) hold a degree from a recognized
University/Institution; or
details of competent technical staff, (b) is a registered pharmacist; or
under whose direction and supervision (c) has passed intermediate examination or its
the sales activity of medical device shall equivalent examination from a
be undertaken, who shall possess the recognised Board with one-year experience in
following educational qualification and dealing with sale of medical
5 experience, namely devices;
brief description on other activities
carried out by applicant, namely, storage
of drugs, medical items, food products,
stationeries, etc., or any other activities
carried out by the applicant in the said
6 premises; and Activity flowchart and brief descritption
an undertaking to the effect that the
storage requirements to sell, stock,
exhibit or offer for sale or distribute a
7 medical device will be complied with. Undertaking template
conditions of registration
The registration certificate holder shall
provide adequate space and proper
storage condition for storage of the
1 medical devices.
The registration certificate holder shall
maintain requisite temperature and
lighting as per requirements of such
2 medical devices.
The medical devices shall be purchased
only from importer or licensed
manufacturer or registered or licensed
3 entity.
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
4 applicable) shall be maintained.
All registers and records mentioned
under these rules, shall be preserved for
a period of not less than two years from
5 the last entry, therein
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.
ale or distribute a medical device including in vitro diagnostic medical device.—
GOOD DISTRUBUTION DECLARATION
20.1. Self-inspections shall be included in the quality system. These shall be
conducted to monitor implementation and compliance with the principles of GDP
and, if necessary, to trigger corrective and preventive measures.
20.2. A designated, competent person shall conduct self-inspection in an
independent and detailed way.
20.3. There shall be records of self-inspection results which shall contain all
observations made during the inspection and if required proposal for corrective
measures. There shall be an effective follow-up programme and evaluation of
inspection report and corrective action taken by the management.
CDSCO Registration for cosmetic imports includes two levels of assessment. The first is the application and the document asse
This article provides you a document checklist for pre-screening of your CDSCO Approval application
Cover Letter
Cover Letter should entail the your purpose behind applying CDSCO certificate. You have to clear, concise and convincing whe
Application Form 42D
Needless to say, you should make no mistake as you enter your details in the application form. For the pre-screening, the deta
1. The application form should be signed & stamped by you.
2. The details of the cosmetic product, including:
a. Name of the product
b. Variant of the product
c. Actual manufacturer details
d. The categorization of the product
3. Name of your Authorized Agent, the one filing the application on your behalf.
4. Name and address of the factory premises.
Fee Challan
You need to provide TR-6 Challan specifying the CDSCO registration fees. The registration fee is USD 1000 for each proposed b
1. Bank's stamp
2. Name of the drug
3. Address of the manufacturing site
4. Head of the fee details
Copy of the valid license
Copy of the valid whole sale license or Manufacturing license for the Indian Origin manufacturer
Authorization letter from the company
The company's authorization letter that let's the authorized agent collect and submit the documents.
Undertaking of the Authorized Indian agent
Provide an undertaking that contains the name and designation of the Authorized Agent who is representing your certification
Plant Master File
Provide a notarized copy of the plant master file
Master file
Provide a Notarized copy of the master file
Product Registration certificate
Provide a copy of the product registration certificate from the country in which the cosmetic product is manufactured.
Labels of the cosmetic product
Provide the details of the label to be posted on the packaging of the product. The label should entail the following:
1. Name of the cosmetic product
2. Name of the manufacturer
3. Ingredients of the cosmetic product.
4. Wholesale License number
5. Import license number
cation and the document assessment, also known as pre-screening. At this level, the Central Drug Standard Control Organization scrutinize
r, concise and convincing when drafting this particular document.
or the pre-screening, the details that CDSCO scrutinize is as follows:
USD 1000 for each proposed brand. Don't deposit this document if your challan doesn't have the following:
representing your certification requirements to the CDSCO.
duct is manufactured.
ntail the following:
Control Organization scrutinizes your application and your documents. The core of its assessment is the correctness of the documents that
ectness of the documents that you submit.
