MSME medical devices cos urge govt to extend deadline for registration of medical devices

New Delhi, October 6, 2021:

The small and medium scale medical devices manufacturers and importers are worried that their operations might be impacted and there will be a shortage of essential medical devices if the government does not pay heed to their requests to extend the deadline for registration of medical devices with the drug regulator. 

The surgical devices manufacturers have sought the drug regulator to waive off the ISO 13485 certification on Class A, non-sterile surgical instruments for registration.

The Surgical Instruments Development Society (SIDS), Jalandhar, has written a letter to the Drugs Controller General (India) recently, requesting waiver of ISO 13485 on Class A, non-sterile surgical instruments for registration. The registration or manufacturing license is to be done on the basis of self-declaration on a simple checklist or as per ISO 9001:2015 certifications.

“Surgical and dental instruments manufacturing are cottage based on skilled workers working for decades and involve many processes like forging, filling, grinding, polishing etc…and minimal machinery used. These instruments are tools for surgeons and not any drug or cosmetic,” said Harvinder Singh, general secretary, SIDS. Singh requested the government to extend the time period for ISO 9001 for one year.

The Surgical Manufacturers and Traders Association (SMTA), which has approached the Delhi High Court almost two years back against the government’s notification which extended the definition of drugs to all medical devices, has said that the licensing process itself is rigid and very expensive and many small and medium scale firms would end up closing down if the registration is made compulsory.

According to the government’s plan, the medical devices regulatory process starts with voluntary registration, which began in April, 2020, which will move to compulsory registration, for Class A and B products, starting from October 1, 2021 and Class B and C it will start from October 1, 2022. All the classes will eventually move to the licensing regime one year from there. Complying to ISO 13485 is one of the requisites to get the registration and this is one of the major hindrance for the micro and small firms. The Covid-19 onset also delayed the efforts of the industry to get the ISO certification and register themselves with the drug regulator.

Importers are also worried whether they would be allowed to import the devices in the Class A and B category from this month, if they are not registered with the regulator till now. Many importers are hesitant to import and this might end up in shortage of devices. The licensing fee for imports is already 37 to 140 times.

“People are already hesitant to import because if there is no registration, they are afraid whether it will not be cleared from the Port. Products which are already notified, people are afraid to import, because till the time you don’t have a license, you cannot import. For non-notified products also if you are not registered, you cannot import,” said Puneet Bhasin, secretary, SMTA.

The Surgical Dealers and Manufacturers Association, Mumbai, said that since notified bodies are going to be busy, there should be a time of one year for compliance with ISO 9000. Similarly, the time gap for ISO 13485 should be increased by two years, said Chetan Nayyar, of the Association. The Medical Surgical and Healthcare Industry Trade Association, also raised similar requests to the authorities.

The Association of Indian Medical Device Industry (AiMeD) said that a manufacturer cannot make clean room to appropriate requirements without knowing the class of device that falls in which product category. For most MSME it is expensive to invest Rs. 20-30 lakh in a clean room in a rented building and later make changes in it as per the auditors’ direction. Classification list was initially made available for 24 categories for around 1,800 items on September 3, 2020 and intensive discussion regarding each category is still going on to cover the categories and items misled out.

There are also technical glitches on the CDAC website, where there is a separate website of CDSCO for medical devices. Many units are not able to access the notifications and circulars in this website and only trained users of already licensed manufacturers are able to access them which are available on a separate CDSCO portal for pharma.

“These are teething problems of a Herculean task during transition times which have to be jointly addressed as it is a new system and support required from government departments to issue clarifications so that entrepreneurs know how to fulfil the regulatory requirement, especially if they already are not having ICMED/ISO 13485 per even ISO 9001 QMS certification for enabling continuity of business,” said Rajiv Nath, forum coordinator, AiMeD. ICMED, a voluntary certification, can help manufacturers to get ISO 13485 easily and move to the licensing regime from October 2022, he added.

The DCGI, Dr V G Somani, in a recent letter to the State drug controllers, said that the industry has made representations regarding the deadline and “The representations are under consideration of the ministry of health and family welfare, Government of India.”

“You are requested to take note of the same with a view to ensure uninterrupted supply of such medical devices and access to the patients till a decision is taken on the representations,” said the DCGI to all drug controllers.Pharmabiz