Clarification Regarding Medical Devices from CDSCO
Clarification Regarding Medical Devices from CDSCO
Introduction
Medical devices have come a long way due to advancement in technology and are being used in each and every aspect of medical treatment. The Central Drugs Standard Control Organization (CDSCO) plays an important role in safeguarding and enhancing public health by ensuring the quality, safety and efficacy of drugs, cosmetics and medical devices. It is the Central Drug Authority in India for fulfilling functions allocated to the Central Government under the Drugs and Cosmetics Act.
Our highly skilled and trained team at CliniExperts provides a stress-free approach to obtain your manufacturing or import license and registration for medical devices. This way you can focus on important aspects such as manufacturing the medical device and let us worry about the tedious licensing and registration procedures.
Clarification Concerning Medical Devices
Medical devices are classified under notified and non-notified medical devices. Notified medical devices require complete registration while non-notified medical devices only require a clarification letter for import or manufacturing. However, both do require a manufacturing license, if being manufactured here in India. Furthermore, registration is not required for import of non-notified medical devices in India. However, certain devices that are regulated as drugs under the Drugs and Cosmetics Act and Rules require registration and import license to India such as:
- Blood group sera
- Ligatures
- Umbilical tapes
- Sutures
- Tubal rings
- Staples
- Intra Uterine Devices (IUD)
- Condoms
- Surgical dressing
- Blood or blood component bags
There are stringent and lengthy rules and regulations put in place to guarantee appropriate manufacturing of medical devices. The most recent clarification was post in 2014 by the CDSCO in response to several requests for clarification of unclear guidelines. In 2014, the CDSCO posted additional clarification information regarding the control of various medical devices. The one before that was in 2012.
Clarification as regards the regulatory status of any medical device to be registered in India is as follows:
- Registration certificate in Form 41
- Import License in Form 10
- NOC not needed at the port office in case they don’t fall under the Drugs and Cosmetic Act, 1940 & Rules, 1945
- In case of medical devices manufactured outside India, an approval from that country is needed and a Free Sale Certificate from that country needs to be submitted
- All Peripheral Stents are covered under the Drugs and Cosmetics Rules and therefore need to be registered for import and licenses approved by Central License Approving Authority (CLAA) by the manufacturer
- All “Cardiac Patches” and “Occluders” are considered as “Internal Prosthetic Replacement” (Medical Devices) and need to be registered under the provisions of the Drugs and Cosmetics Rules and require a valid registration
- If a stent is already used abroad a six month clinical trial needed to be done on 100 patients in India
- For a new stent a twelve month clinical trial on 100 patients is needed to introduce in India
- Any change in the Design and/or change in Material and/or change in Composition of pre-approved Medical Devices requires prior approval by the Drugs Controller General of India
CliniExperts: Your one-stop shop
- We offer complete support for our customers by helping them overcome the challenges with the provisions of the Drugs and Cosmetics Act, 1940 & Rules
- We help our customers fill out all the form required for their procedure
- We make sure all the declarations and conditions are understood by our customers
- We respect the value of time and are committed to finishing the paperwork on time