The Pakistani government has enacted legislation establishing a formal regulatory framework for medical devices and in vitro diagnostics.

The law, known as the Medical Device Rules, 2015, creates a risk-based classification system with principles of safety and performance, conformity assessment and registration requirements, and rules for product labeling. It also sets standards for conformity assessment bodies that certify devices before they enter the market.

A Medical Device Board, housed within the Drugs Regulatory Authority of Pakistan, will be responsible for registering CABs and devices, licensing establishments and issuing import and export permits.

The law also calls for devicemakers to have quality management systems that comply with ISO 13485. Manufacturers of Class B products must maintain a QMS, but may exclude design and development control and process control. Class C and D devices require a full QMS and on-site audits to verify compliance.

Companies seeking to register devices in Pakistan must provide clinical evidence of the product’s safety and effectiveness. Data from trials in the U.S., EU, Canada, Japan and Australia will be accepted for registration, the law says.

Registration fees are set at US $200 for locally manufactured devices and $1,000 for imported devices. Other fees range from $10 for an export permit to $1,000 for an establishment license.

The law also covers good distribution practices, customs clearance certificates, vigilance systems that include distribution records, complaint handling, problem reporting, corrective actions and recall procedures. Manufacturers of Class B, C and D devices are subject to audit of the postmarket surveillance system by a CAB.

Advertising is also covered under the law. Devicemakers must get MDB approval before running an ad and cannot spend more than 5 percent of their annual revenues on product promotions.

The law comes a little more than two years after Pakistan’s drugs authority was established and accomplishes what neighboring India has repeatedly failed to do — create a distinct framework to oversee medical devices.

Pakistan will face challenges, such as resources at the government level to regulate devices and sufficient reimbursement opportunities for companies in the market, not to mention hospitals and trained healthcare workers that can properly use devices, says Vince Suneja, CEO of TwoFour Insight Group.

Pakistan’s device market is small and growth is affected by ongoing sociopolitical problems and recurring security threats, says BMI Research. Total volume in 2013 was about US $260 million, with the market projected to reach $352 million by 2018. Imports account for more than 90 percent of the market, with surgical instruments comprising the bulk of the limited domestic manufacturing sector, the firm says.

Many of the sections in the law include templates. Read device rules at www.fdanews.com/03-15-DRAP-Regulation.pdf. — Jonathon Shacat