Wednesday, October 5, 2022

New guidelines and regulations turn on the alert alarm for aligner industry!

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May 14: Aligner market is expanding in India like never before. More and more companies are applying all the possible tools and techniques to be at the topmost place in the clear aligner industry in India. The race to lure the prospective customers is so fierce that few amateur companies are heading in the wrong direction and fooling the customers. Since the pandemic Covid19 hit the country, few aligner companies started ‘direct-to-home’ aligner services. As convenient and easy it may sound but teeth straightening via aligners is a medical process and needs proper doctor-directed treatment. The unsatisfied customer complaints start to erupt leading the court to order strict action against any malpractices regarding this medical process. Dental Council of India issued a public notice where it stated that engaging untrained technicians and offering at-home services to the patients bypassing the professional expertise of the dentists, the companies were violating the provisions of Clinical Establishments (Registration and Regulation) Act 2020, among others. 

In the light of keeping a proper check on the manufacturing and sales of medical devices the authorities have taken a step further by incorporating the medical devices in the same category as that of medical drugs regulation. Therefore, manufacturing and sales of medical devices will be as strict and controlled like that of medical drugs in India. The giant step has been taken to alert the medical device companies and deter them from any malpractices on their part. 

CDSCO (The Central Drugs Standard Control Organisation) is preparing newer guidelines to be followed by all the old and new medical device companies. Clear aligners being orthodontic devices also fall in the ambit of medical device companies. These stricter guidelines are being set to weed out the companies that are focusing on profit making rather than quality manufacturing and service. For any company to be able to design and manufacture medical devices, an ISO: 13485 certification is mandatory. To set the bar higher, the ISO: 13485 certification can only be granted by CDSCO notified bodies only. This ensures that no other unauthorised body can grant the ISO certification to any medical device manufacturing company. So, if the company wishes to be registered as a manufacturer of medical devices, it must have applied for the ISO 13485 certification before the month of February 2022 and the last date to get the approval is 30th September 2022. 

These regulation and certifications will make it difficult for unmindful companies to penetrate the medical device manufacturing market easily. If the companies fail to procure the ISO:  13485 certification, the manufacturing licence of the same will be cancelled immediately. Only focused and dedicated companies will lead the market. In case of clear aligner manufacturing, experienced and committed companies like 32 Watts, Toothsi, Illusion & Flash are among few serious players who have already obtained the ISO: 13485 certification.  Meanwhile, the newer guidelines and regulations will be a tough row to hoe for relatively new players in the clear aligner industry such as Snazzy, Glamyo etc.

Considering the strictness in medical device manufacturing and sales industry in India only the companies who aim to manufacture and service ethically and responsibly will have a foothold in the aligner manufacturing market. The ISO certification and other regulations will act as window of credibility for both the manufacturing companies and the customers.  

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