R&Q's Blog

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

 

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!

FDA 510(k) Memorandum #K97-1 “Deciding When to Submit a 510(k) for a Change to an Existing Device

The FDA is looking for industry input for the revision of FDA 510(k) Memorandum #K97-1 “Deciding When to Submit a 510(k) for a Change to an Existing Device,” January 10, 1997. This is a critical go-to document for the average Regulatory Engineer, so I have been thinking about what I would change to make it more straight forward. While I can appreciate how difficult it is to make general rules that can apply to an infinite variety of products, there are sections of this document that could certainly be clarified.

Crowd Source in Medical Devices?

Collaborative development, or for the purposes of this post we'll call it "crowd sourcing", seems to be discussed and used more frequently in the current business environment. Obviously, crowd sourced projects have been around for a long while (Wikipedia is just one well-known example), but other examples are appearing more frequently, including in the medical device industry.

March Madness

The season is upon us. Unfortunately, the season is not spring…winter still seems to be lingering. However, the season of March Madness is in full swing! Everyone’s bracket selections are in, and we wait to find out who is the National Champion.

HFES Health Care Symposium – What’s New in Human Factors and Usability?

Last week I had the opportunity to attend the Human Factors & Ergonomics Society Health Care Symposium. Since I work on medical devices, I mainly went to the presentations in the medical devices track and found them to be very interesting and educational. The opening keynote speaker, Dr. Ross Ungerleider, talked about practices that foster an environment (particularly in an operating room) conducive to innovative thinking and learning from human error. There were a number of presenters from the medical device industry who shared case studies, lessons learned, and various models for applying usability in their individual companies and departments. We were also fortunate to learn about some changes coming for human factors standards and the latest FDA perspectives on best practices, which I thought I’d share with you this week.

Getting Control of Supplier Controls

It seems that for one reason or another supplier controls are a requirement that slips through the cracks of even some of the largest medical device organizations. Those of us in the medical device field should know better since 21 CFR Part 820 clearly includes requirements that medical device manufacturers shall have controls over purchased products or services related to medical device being manufactured.

Latex and DEHP and BPA, Oh my!

They’re just as frightening as Lions and Tigers and Bears, but how much do you know about them? Are they in your medical devices?

Technology Overkill?

Over the past few years, there have been some really great technologies that have changed the way we live our lives. Smartphones are the easiest example. Life would be a lot different if I didn’t have instant access to my e-mail, the weather, the spinning schedule at my gym, or Fruit Ninja. While many technology advancements have certainly improved the way we live our lives, there are some that may be technology overkill. Like a washing machine or dryer that you can remotely monitor and control from your PC, or a Mercedes Benz that can shift the direction of your headlights away from the oncoming traffic. A washing machine that you turn on yourself, or headlights that point straight ahead are alternative options that accomplish the same end goal, they just do it much more cost-effectively than the high-tech ways. Don’t get me wrong, the development and engineering that went behind these things is super impressive, but sometimes, the bang is just not worth the buck.

New Medical Devices Coming Soon to a Hospital Near You

Recently I came across a FoxNews article (‘Medical breakthroughs on the horizon for 2013’ by Dr. David Samadi) that got me excited. The reason why I pursued the medical device industry was to be in a field that impacted people; a field that matters. I don’t care who you are – anyone with a loved one who has ever been sick, or needed surgery, etc. has been impacted by medical devices in some way. What impresses me is how medical devices are always pushing the boundaries.

Headaches

The FDA received funding to increase its workforce at the CDRH for 2012 and 2013. They have set aggressive goals to improve the turnaround times for 510K approval. They have instituted programs to retain their employees and to increase the reviewer to manager ratio. My colleagues and I were very excited to hear about it. These changes will make things better for the public and smoother for us, especially after these new employees are fully trained. Good news, right?

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