GUIDELINES FOR LABELING OF MEDICAL DEVICES FOR EXPORT

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Reference page 1 – Opening Line of Drugs & Cosmetics Act 1940 – Reads as follows:

An Act to regulate the import,  manufacture, distribution and sale of drugs (and Cosmetics).”

 

Above statement does not express intention to regulate Exports. However rule 94 of Drug and Cosmetics Act specifies certain exemptions for the label on packages or containers of drugs for Export (Provisions of rule 94 have been taken in consideration in the preparation of these guidelines).

 

GENERAL

 

Labels on packages of container for medical devices shall be adopted to meet the specific requirements of the country to which the device is exported whose onus for compliance is the importer/consignee and not the Indian Exporter.  In addition to the product specific requirements, the following particulars shall appear on the on the packages or containers as appropriate.

 

A. Non-Notified medical devices (Not Mandatory – Informative Guideline only)

 

(a) Name of the Device

(b) Batch No. or Lot number

(c) The name and contact information of the manufacturer or importer or marketing company on unit pack or shelf pack as appropriate unless not required to be labeled by the consignee/purchaser.

OR

(d) Information as per buyer’s instructions.

 

B. For Notified* medical devices

 

(a) Brand Name & Name of the Device (as per terminology used in Importing Country) 

(b) Batch No. or Lot number

(c) Date of expiry, if required

(d) The name & address of the manufacturer.

(e) Manufacturing License No.  Preceded by the letters ‘M.L. No’

 

 

 

 

 

 

 

 

 

 

C. For Notified* devices manufactured in Private labeling (Brand name of Third Party)

 

(a) Name of the device (as per terminology used in Importing Country) 

(b) Batch No. or Lot number

(c) Date of expiry, if required

(d) The name and address of the Consignee or Importer or Exporter or Marketing Co.

 

The name of consignee/supplier may be prefixed by the words.

 

- Manufactured for

            OR

- Marketed by

 

            OR

– Just the name & address only

            OR

- Symbol for legal manufacturer (the person placing the device on the market as per European Law) per clause 5.1.2 of EN 980: 2008         

 

Without necessarily mentioning ‘Made in India’ as this is dependent on the law of the Importing Economy.

 

Note: - The word ‘Manufactured By’ shall not appear with the name of the overseas consignee unless qualified by “Made in India”

 

In such case where the details of the Indian Factory (Primary Manufacturer) are missing the label on packages shall bear a code no. (Neutral code) as approved by the regulatory body (State or CLAA) to enable traceability to the Indian Licensee.  There is no need for the neutral code to be preceded by letter NC or NCNO.  The location of this nondescript code may be in the proximity of the address to enable easy location. 

 

There is no need for the exporter to submit a NOC letter from DCGI/CLAA for items under (a) above or in case the exporter has a valid manufacturing license/Free Sales Certificate for items under (b) above or has a valid manufacturing license/Free Sales Certificate &Neutral Code labeling permission for items under (c) above.

 

*Note: - For the 10 items notified by the gazette notification number 1077 dated 06.10.2005               and 19 items clarified on 20.03.2009 suitable transition period will be permitted to comply with above guidelines and will be defined when the revised Schedule M-III gets notified.

Copyrights 2009. Association of Indian Medical Device Industry.