Medical devices sector is becoming an integral part for delivering proper diagnosis, prevention and better clinical outcomes and it is in synchrony with rapidly evolving healthcare industry. While various policies and regulatory developments framed by the government have helped the industry progress steadily, many manufacturers believe that the Centre should do more at the policy level to facilitate patients.
The medical devices sector in India was estimated at USD 4.2 billion in 2014 and is expected to grow at a CAGR of 16 per cent during 2014-2018, according to FICCI and QuintilesIMS report. Contributing factors to this growth include the growing burden of disease in India, the increasing aging population, larger spends on healthcare, better health infrastructure and advancements in technology. HealthCare Federation of India (NATHEALTH) states that the Indian medical device industry would grow faster than the global medical devices industry by 2020. The Indian market is among the top twenty in the world by market size, and fourth in Asia after Japan, China and South Korea.
Medical Device Draft Rule 2016
In October 2016, the draft on Medical Devices Rules was published by Central Drug Standards Organisation (CDSCO) which is a part of the Ministry of Health and Family Welfare. Some of the key regulations are:
• The manufacturer shall provide evidence of previous sale in India and apply for licence within a period of one hundred and eighty days from the date the device is notified.
• The draft proposes classification of the devices licenced in the country based on the severity of risks associated with them. The class-based risk system for medical devices ranging from Class A (low risk) to Class D (high risk) with Class B and C occupying the middle part (low moderate risk and high moderate risk) for medical devices other than IVD's and IVD medical devices.
• Already notified medical devices marketed in India before in time to the starting of these rules shall continue to be marketed as before till the expiry of 18 months or the current validity of the licence from the beginning of these rules. Class A medical devices manufacturers shall not be required to be licenced and these devices are self-regulated in accordance with the applicable standards.
• A licence shall be granted if the medical device is having free sale certificate (FSC) issued from the national regulatory authority or any other competent authority of any of the countries.
• The medical device imported from countries other than those mentioned in the above Class C and Class D medical devices may be granted after its safety and effectiveness tested through clinical investigation in India and for Class A and Class B it is granted through its published safety and performance data or through clinical investigation in the country of origin along with free sale certificate (FSC) from the country of origin.
• A licence shall remain valid for five years from the date of its issue.
• Before the due date fee along with a late fee calculated at the rate of 2% of the licence retention fee for every month or part of that up to 6 months and after that time the license shall be deemed to have been cancelled.
• In case of any change in the intended use or any major change authorised agent shall obtain prior approval from the Licencing Authority.
• Labelling of Medical Devices:
i) Sterile devices: The sterilisation date may be given as the date of the manufacture of the device.
ii) Expiry date: Raw materials details such as stainless steel/titanium and supplied non-sterile, the expiry date may not be necessary.
iii) If the device is supplied as a sterile product, its sterile state and the sterilisation method should be indicated.
iv) If the device is intended for clinical investigation: to overprint on the label with the words "For Clinical Investigation Only"
v) Devices or in vitro diagnostics which are not sold to customer or patient directly and are sold for use by hospitals or diagnostic labs provide affixing additional label or sticker on outer shelf pack information.
vi) Medical devices on which the information cannot be printed legibly due to the small size limitations, shall include the information necessary for product identification and safety.
• Shelf life of the medical devices: The shelf life of the medical devices shall not exceed 60 months from the date of manufacture.
According to Sushobhan Dasgupta, Managing Director, Johnson & Johnson Medical and MTaI founding member, "The move towards creating a separate draft policy on medical devices, the fact that the Government has taken notice that devices are different from drugs, is a very welcome change and much appreciated by the industry. Having said that there are some rules that need further amendment."
He said that the draft says that companies should specify the physical manufacturer's address as well as the manufacturing date of the device as per labelling requirements. However, the industry believes that this may result in additional investments in production which will increase market price of the devices.