R&Q's Blog

Medical device industry news and trends - and the resources to understand and act on them.

 

License Amendment Triggers in Canada

Sometimes changes in process can have a dramatic effect on product registration. There are several events that can cause a re-registration of a registered medical device. A new product name, part number, material, manufacturing site, country of origin, business name or manufacturing process are common re-registration triggers. It all depends on the specific regulations of the country involved.

I recently had to deal with a company that had changed contract manufacturers; the legal manufacturer and owner of design control remained the same. This move also involved a change in the country of origin. We were concerned specifically how this affected the current license in Canada. I read the Health Canada Guidance for Interpretation of Significant Change of Medical Device and the License Amendment Fax-Back Form from the Health Canada website. After reading these documents, I felt that an amendment to the license was necessary. I wasn't entirely sure. I asked a few colleagues for their opinion. After reading carefully, none of us were fully clear what path we needed to take in order to meet the requirements.

However, the one great thing about Health Canada is that the Medical Device Bureau is as polite and helpful as the rest of the country. We were quickly able to get clarification via email from the Device Licensing Services Division. Basically here is what we found out: If the products in question are Class II devices, then a License Amendment Fax-Back Application is not required (you can inform Health Canada when the product is renewed). However, if the devices in question are Class III or IV, then a License Amendment Fax-Back Application is needed.

Luckily, our devices were Class II, so we did not need to fill out the License Amendment Fax-Back Form. Thanks for your help, Canada!

 

 

Health Canada Guidance for Interpretation of Significant Change of Medical Device please see the following website:

http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/md-im/applic-demande/guide-ld/signchng_modimportante-eng.pdf

License Amendment Fax-Back Form please see the following website:

http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/fb_licnamechng_fm_modnomhom-eng.php

India Medical Device Labeling

 

This week I will provide some information about labeling in India. CDSCO (Central Drugs Standard Control Organization) regulates the medical device industry in India. Only medical devices that CDSCO has put in the “Notified Devices Category” require registration. There are very few product types on this list and they are regulated as “drugs”. Registration is not required for import of non-notified medical devices in India. Please refer to the link below for a list of the notified device categories that must be registered in India:

http://cdsco.nic.in/Medical_div/list%20of%20notified%20medical%20device.0001.pdf

If your device does not fall into one of the types on this list, it doesn’t require product registration.

For Medical Devices that do fall under Notified Devices Category (per CDSCO), products are required to have labeling as per the labeling requirements under GHTF guidelines and Rule 96 of the Drugs and Cosmetic Act, (which can be found at the following link):

http://cdsco.nic.in/Drugs&CosmeticAct.pdf

In India, medical devices are categorized as “drugs”. Some of the labeling requirements in Rule 96 are specific to drugs, and will not pertain to medical devices. According to rule 96, the following items must be on the labeling for Notified Devices:

1. product description

2. number of units of contents,

3. The name of the manufacturer and the address of the premises of the manufacturer where the product has been manufactured.

4. A distinctive batch number, being preceded by the words ‘Batch No.’ or ‘B. No.’ or ‘Batch’ or ‘Lot No.’ or ‘Lot’.

5. Every product manufactured in India shall bear on its label the number of the license under which it is manufactured, the figure representing the manufacturing license number being preceded by the words “Manufcaturing Licence Number” or “Mfg. Lic. No.” or “M.L.”.

6. Date of manufacture, and the date of expiration

In addition, these products also need to comply with labeling and local laws as per Drug Price Control order and Standard Weights and Measures Act 1976 & Rules 1977.

As per Standard Weights and Measures Act 1976 & Rules 1977, the manufacturer shall indicate the following information on the package:

1. Name and Address of Manufacturer/Importer/Packer
2. Quantity
3. Generic Name of Product
4. Maximum Retail Price (M.R.P.) inclusive of all taxes:
5. Date of manufacture/ (Imported or Packed) Expiration Date
6. Contact information (Name, Address, Telephone Number and E-mail address) for Customer Complaint

Most of which is redundant.

Some frequently asked questions can be found on the CDSCO website at:

http://cdsco.nic.in/FAQ-IMPORT%20&%20REGISTRATION%2002022013_DONEE.pdf

Good luck with your labeling!

Regulatory Intel - Jan. 21, 2013

Wrap-up of a few notable news stories from last week:

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