IPC To Come Out With New Standards On Performance, Quality For Medical Devices

Mumbai, 31 Oct 2018: In order to align with the requirements of new medical device rules (MDR) 2017, Indian Pharmacopoeia Commission (IPC) has been assigned to set new standards on performance and quality for health ministry's draft guidance document for medical devices. 

Guidance document for medical devices will be a techno-legal document which will provide manufacturers, license holders, regulators and healthcare professionals with requisite information on regulatory and technical requirements of medical devices. 

Informed a senior health ministry official, “Central Drugs Standard Control Organisation (CDSCO) would be providing the legal inputs on the same and IPC will offer technical inputs to make the document comprehensive and purposeful for the stakeholders.”

The document will also offer knowledge on classification, registration process, grouping and labeling. In addition to the new MD Rules, the document would be based on the standards adopted in Indian Pharmacopoeia 2018, British Pharmacopoeia, Japanese Pharmacopoeia, European Pharmacopoeia and the Bureau of Indian Standards. 

The draft was made available to the stakeholders for their suggestions and recommendations and a meeting was organized and chaired by Dr G N Singh, secretary-cum-scientific director, IPC order to review the suggestions. Experts from CDSCO, Indian Institute of Technology (IIT) and medical device representatives from various associations participated in the review process. 

Drafted as per new MDR 2017, the document aims to serve as a ready reference for all the stakeholders such as medical devices, pharmaceutical industries, suppliers and distributors

The document will also cover definition, notified devices, risk based classification, testing and accreditation, Quality Management System (QMS), Standards and post marketing surveillance (PMS).

In view of the safety aspects related to medical devices, a suitable advisory up to the year 2025 has also been recommended which has to be issued by the medical device company for medical professionals. The advisory shall provide recommendations to orthopaedic surgeons for patient management including regular follow-up.

Health ministry also plans to device a mechanism by which online information of medical devices could be made available about any withdrawal by regulatory agency or voluntary withdrawal by the company of drug or device safety and efficacy issues of drug or devices. 

As per MDR -2017 medical devices are classified into categories A, B, C and D depending on the risk factor. They include ablation devices, catheters, bone cement, cardiac stents, contraceptives like tubal and fallopian rings, male and female condoms, disinfectants, disposable hypodermic needles, heart valves and internal prosthetic replacements like penile, dental, vaginal, breast, retinal and cochlear implants. Pharmabiz