For the last 70 years, only a handful of medical devices have been regulated in Pakistan under its Drug Act of 1976. In an attempt to control the quality of the devices being sold and used in the country, the Drug Regulatory Authority passed the Medical Device Rules in early 2015; however, these regulations could not be implemented due to a lack of conformity assessment bodies in the country.
Now, Pakistan has new and improved regulations. The Medical Device Rules 2017 address everything from conformity assessment to fee structures.
What’s new with these Rules?
- Assessment and evaluation of medical devices will be carried out by Medical Devices Board (MDB). This role previously belonged to the conformity assessment bodies.
- MDB will be comprised of Federal and Provincial government officials, as well as physicians, surgeons, engineers, medical technologists, and pharmacists, especially those with backgrounds in manufacturing, quality control, and hospital pharmacy.
- Healthcare Devices Association of Pakistan (HDAP) and Pakistan Chemist and Druggist Association will be included in the MDB as observers.
- Product registration has been streamlined and the fee structure has been revised.
- Rules of enlistment for Class A devices have been introduced.
- Technical documentation requirement for medical device registration has been eliminated for the following products:
- Those that are imported from the U.S., Japan, Australia, Canada, Austria, Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Switzerland or the U.K.
- Those that are pre-qualified by the World Health Organization (WHO)
- Those that have been CE marked by manufacturers who have been assessed by conformity assessment bodies listed in the E.U.’s NANDO database
- Inspections of device manufacturers that are based outside of the country will be conducted by representatives of MDB.
- An exemption period for the registration of medical devices has been defined.
Need more details? Attend our free webinar on Wednesday, July 25th at 11am. Join us in a conversation with a leading regulatory expert from Pakistan to learn the ins and outs of the country’s new medical device regulations and gain expert advice on how your company can best prepare for these changes. Register here!
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